Back to what changed for PTSD

Reported trial results for PTSD

Every PTSD trial Voxsanity tracks that has reported results to a public registry, newest first. These trials have finished, so they are not recruiting. Not medical advice.

173 trials have reported results.

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

  • NCT04044534 · results posted 13 July 2026

    According to the results reported on ClinicalTrials.gov, this trial (NCT04044534) involved 6 participants, all of whom completed the study. It used a crossover design, meaning each participant tried both treatments at different times — in this case, intranasal insulin and a placebo (an inactive substitute). The trial was measuring changes in PTSD symptoms using a standardised clinician-administered questionnaire called the CAPS-5, which covers 20 symptoms across four areas: intrusive memories, avoidance, negative thoughts and mood, and being on edge or reactive. Scores on this scale range from 0 to 80, where higher numbers indicate more severe symptoms. The reported data shows that, on average, participants in the intranasal insulin group had a score change of −7.33 points on the CAPS-5 scale, while participants in the placebo group had a score change of −7.00 points. In both cases, a negative number means symptoms were rated as lower after the one-week period compared to before it. The two numbers were very close to each other. No other outcome measures were reported in the submitted data. It is worth noting that with only 6 participants, this was a very small trial — likely an early-stage study intended to test whether a larger trial is feasible, rather than to draw broad conclusions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT05862467 · results posted 2 July 2026

    According to the results reported on ClinicalTrials.gov, this trial enrolled 28 autistic adults who received a treatment called Written Exposure Therapy — a structured approach where participants write about traumatic experiences over several sessions. The trial was measuring changes in post-traumatic stress disorder (PTSD) symptoms as its main focus, and also tracked changes in depression, anxiety, loneliness, general psychological wellbeing, and a pattern called "experiential avoidance" (a tendency to avoid distressing thoughts or feelings). Of the 28 people who started, 23 completed the treatment phase, 19 completed a one-month follow-up check, and 18 completed a six-month follow-up check. The reported data shows that on the main PTSD symptom scale (scored 0–80, where higher means more symptoms), the average score across participants was 40.64 at the start, dropping to 22.00 after treatment, 19.11 at one month later, and 17.82 at six months later. For the secondary measures, the reported data shows average depression scores (0–27 scale) moved from 14.25 at the start to 9.44 at six months; anxiety scores (0–60 scale) moved from 33.79 to 23.47; loneliness scores (3–9 scale) moved from 7.68 to 6.65; general psychological adjustment concern scores (6–42 scale) moved from 26.93 to 20.06; and experiential avoidance scores (15–90 scale) moved from 57.59 to 47.82. These figures represent group averages at each time point as reported, and no comparison group (such as a control group receiving no treatment) was included in this trial. It is worth noting that because this trial had only one group and no comparison group, the reported numbers alone cannot tell us what caused any changes observed. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT05280691 · results posted 30 June 2026

    According to the results reported on ClinicalTrials.gov, this trial involved 885 family members of patients in an intensive care unit (ICU). Of these, 412 people received a special family support intervention on top of usual care, while 473 received usual care only. The trial was measuring things like how satisfied families felt with the care provided, how well staff communicated with them, how supported they felt by nurses, how well the family was functioning as a unit, how resilient families felt, and their overall satisfaction with life — all tracked using standardised questionnaires. The reported data shows that, for the main outcome — family satisfaction with ICU care, scored on a scale of 0 to 100 (where 100 means completely satisfied) — the family support group scored 81.78 and the usual care group scored 79.39. For the secondary outcomes, the reported data shows that on a communication quality scale of 1 to 5, the family support group scored 3.82 compared to 3.45 for usual care. For the measure of how supported families felt by nurses (scored 14 to 70), the family support group scored 48.36 versus 39.33 for usual care. For family functioning (scored 1 to 4, where lower means better functioning), both groups recorded very similar scores across multiple measurement points, ranging roughly between 1.55 and 1.70. For family resilience (1 to 5, higher is better) and satisfaction with life (5 to 35, higher is better), the reported data shows the two groups scored similarly across all measurement time points, with no notable difference between them. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03974503 · results posted 9 April 2026

    According to the results reported on ClinicalTrials.gov, this trial (NCT03974503) enrolled 48 adults in total — 23 in a group receiving a therapy called Exposure, Relaxation, and Rescripting Therapy (ERRT) and 25 in a group receiving a programme called Sleep and Nightmare Management. Of those, 18 and 21 people respectively completed the study. The trial was measuring things like sleep quality, a heart-rate signal during sleep (called Respiratory Sinus Arrhythmia, or RSA — a measure of how the nervous system influences the heart overnight), nightmare frequency and severity, and symptoms of post-traumatic stress disorder (PTSD). The reported data shows the following numbers across the two groups. For sleep efficiency (the share of time in bed actually spent asleep), the ERRT group started at about 74.9% and ended at about 66.7%, while the Sleep and Nightmare Management group started at about 69.5% and ended at about 71.0%. For the heart-rate signal (RSA), both groups started at similar levels (3.85 versus 2.96) and ended at similar levels (3.46 versus 3.15). For nightmares in the past week, the ERRT group reported going from about 3.2 at the start, to 2.9 after treatment, and 2.3 at the three-month follow-up; the Sleep and Nightmare Management group went from 3.5, to 2.7, then 2.5. For PTSD symptom scores (on a scale of 0–80, where higher means more severe), the ERRT group went from 34.0 at the start, to 26.4 after treatment, and 24.6 at three months; the Sleep and Nightmare Management group went from 34.4, to 29.7, then 28.6. Nightmare severity scores (0–4 scale) followed a similar pattern across both groups. An additional measure of breathing disruptions during sleep (apnea-hypopnea events per hour) was recorded but was described as a pre-specified exploratory measure rather than a primary or secondary outcome. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04228289 · results posted 11 March 2026

    According to the results reported on ClinicalTrials.gov, this trial (NCT04228289) looked at whether oxytocin (a hormone sometimes given as a nasal spray) made a difference to symptoms of post-traumatic stress disorder (PTSD) compared to a placebo (an inactive dummy treatment). A total of 92 people were assigned to receive oxytocin and 88 to receive placebo at the start of the study. By the end, 68 people in each group had completed the trial, meaning 24 people in the oxytocin group and 20 in the placebo group did not finish. The reported data shows that PTSD symptom severity was measured in two ways: by a clinician using a structured interview (called the CAPS-5, scored from 0 to 80, where lower scores mean fewer symptoms), and by participants themselves using a self-report questionnaire (called the PCL-5, also scored 0 to 80, with lower scores again meaning fewer symptoms). For the clinician-rated measure, the oxytocin group's average score dropped by 10.1 points, while the placebo group's average score dropped by 12 points. For the self-report measure, the oxytocin group's average score dropped by 19.4 points, while the placebo group's average score dropped by 25.2 points. In both cases, the reported data shows the placebo group had a numerically larger average reduction in symptoms than the oxytocin group, though the data as submitted does not include information about whether this difference was considered statistically meaningful (that is, whether it was large enough to be unlikely due to chance). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04395157 · results posted 25 February 2026

    According to the results reported on ClinicalTrials.gov, this trial enrolled 100 veterans who were engaged in mental health rehabilitation or recovery programs through the VA (Veterans Affairs) health system in the United States. The study was measuring several things at the same time: how well participants performed on a standardised brain and thinking skills test (called the MCCB), how they performed on a one-hour computerised listening and sound-recognition training exercise, their day-to-day functioning (using a World Health Organization disability questionnaire), and their overall quality of life (using a World Health Organization quality-of-life questionnaire). Of the 100 people who initially consented, 78 completed all follow-up visits over the course of the study. The reported data shows the following numbers. On the thinking skills test (MCCB), the average score across participants was 40.59 on a standardised scale where 50 represents the general population average and scores between 40 and 60 are considered within the normal range. On the computerised sound training exercise, participants completed an average of about 15 levels. For day-to-day functioning (scored 12–60, where higher means more difficulty), the average score started at 25.8 at the beginning of the study and was reported as 23.16, 22.54, and 22.87 at the one-, two-, and three-month follow-up points respectively. For quality of life (scored 26–156, where higher means better quality of life), the average score started at 80.94 and was reported as 83.95, 84.93, and 84.4 at the same follow-up points. A brain signal measurement called Mismatch Negativity — which reflects how the brain automatically detects changes in sound — was recorded at an average of −1.46 microvolts at the start of the study. The reported data also shows that participants missed or cancelled approximately 7% of their scheduled visits across the study period. It is important to note that this trial did not include a comparison group, so all figures reflect measurements taken from the one group of veterans involved. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT06271733 · results posted 20 February 2026

    According to the results reported on ClinicalTrials.gov, this trial looked at the use of Transcranial Magnetic Stimulation (TMS) — a non-invasive procedure that uses magnetic pulses directed at the brain — in people with post-traumatic stress disorder (PTSD). Six participants took part, and all six completed the study. The trial measured PTSD symptom severity as its main focus, and also looked at depression symptom severity as a secondary measure. The reported data shows that at the end of the study, the average score on the PTSD Checklist (PCL-5) — a self-reported questionnaire where 0 means no symptoms and 80 means the most severe symptoms — was 30.8 for the TMS group. For the depression measure (PHQ-9), where scores run from 0 to 27 with higher scores meaning more severe symptoms, the reported average score was 10.4. These are the scores recorded at the time of measurement; the data submitted does not include a comparison score from before the treatment began, so a before-and-after comparison cannot be drawn from the figures provided. It is worth noting that with only six participants, this was a very small study, and the results as reported reflect only this small group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03760731 · results posted 29 December 2025

    According to the results reported on ClinicalTrials.gov, this trial compared two talking therapies for people experiencing what the researchers called "moral injury" — a term for distress that can arise when someone feels they have witnessed, done, or failed to prevent something that goes against their deeply held values. The two therapies compared were Acceptance and Commitment Therapy for Moral Injury (ACT-MI) and Present Centred Therapy for Moral Injury (PCT-MI). A total of 74 people were enrolled across both groups (38 in ACT-MI and 36 in PCT-MI). The main focus of the trial was not to test whether the treatments worked, but rather to examine whether participants found them acceptable and to gather feedback to improve the treatment programs for future research. The reported data shows that, on a satisfaction questionnaire (scored from 8 to 32, with higher meaning more satisfied), 27 out of 29 ACT-MI participants and 22 out of 27 PCT-MI participants who completed the post-treatment assessment provided scores. For the interviews asking participants about their experience of the therapy, 29 ACT-MI participants and 27 PCT-MI participants provided feedback. Among those who left the treatment early, 10 from the ACT-MI group and 14 from the PCT-MI group completed a questionnaire about their reasons for leaving. The reported data also shows scores from several secondary questionnaires — covering things like how much participants felt they were living according to their values, general psychological wellbeing, and satisfaction with social activities — recorded at the start of the trial, at the end of treatment, and at one- and three-month follow-up points. Exact time-point labels for the secondary measure scores were not clearly separated in the submitted data, so a full time-point-by-time-point breakdown cannot be provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03466346 · results posted 2 December 2025

    According to the results reported on ClinicalTrials.gov, this trial looked at two treatments for depression and post-traumatic stress disorder (PTSD) in people who had experienced trauma: a talking therapy called Interpersonal Psychotherapy (IPT) and an antidepressant medication called fluoxetine. The trial ran in two stages. In the first stage, 1,082 people were assigned to IPT and 1,080 to fluoxetine. Those who did not respond well enough in the first stage moved into a second stage, where they were assigned to either switch treatments or combine both — 68, 104, and 160 people started in those three second-stage groups respectively. The reported data shows that at the end of first-stage treatment, 127 of the IPT participants and 89 of the fluoxetine participants still met the threshold score for major depression on a standard questionnaire (a score of 19 or above out of 63). For PTSD, measured using a separate questionnaire (a score of 23 or above out of 80), 173 IPT participants and 108 fluoxetine participants still scored at or above that threshold at the end of treatment. In the second stage, the numbers still meeting those thresholds were much smaller across all three groups — ranging from 6 to 11 participants for depression, and 10 to 20 for PTSD — though these groups also started out considerably smaller. The data as reported does not include information on what proportion of participants in each group scored below the thresholds, so those figures are not available here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04293341 · results posted 6 November 2025

    According to the results reported on ClinicalTrials.gov, this trial enrolled 304 participants in total — 153 in a group receiving a "Transdiagnostic Behaviour Therapy" (a single therapy designed to address multiple mental health conditions at once) and 151 in a group receiving "Disorder Specific Therapies" (separate therapies each targeting one particular condition). Of those who started, 90 and 87 participants respectively completed the trial. The trial was measuring symptoms of three conditions across both groups using standard questionnaire scores: PTSD (post-traumatic stress) using the PCL-5 (scored 0–80), depression using the PHQ-9 (scored 0–27), and panic disorder using the PDSS (scored 0–28). In all three scales, higher scores indicate more severe symptoms. The reported data shows the following score changes across four time points (likely baseline, mid-treatment, end of treatment, and follow-up, though the exact timepoints are not labelled in the submitted data). For PTSD symptoms (PCL-5), the Transdiagnostic group's scores moved from 48.0 → 42.44 → 35.00 → 37.40, while the Disorder Specific group's scores moved from 46.37 → 36.95 → 27.36 → 33.50. For depression symptoms (PHQ-9), the Transdiagnostic group recorded 17.29 → 13.49 → 11.44 → 13.93, and the Disorder Specific group recorded 16.28 → 12.87 → 10.32 → 13.84. For panic disorder symptoms (PDSS), the Transdiagnostic group recorded 13.40 → 11.53 → 9.86 → 9.82, and the Disorder Specific group recorded 12.59 → 11.25 → 6.98 → 8.81. The data does not report statistical comparisons between the two groups, so no conclusions about differences between them can be drawn from the submitted figures alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03937713 · results posted 21 October 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT03937713) enrolled 53 people in total — 26 in a group that received a combination of a brief behavioural sleep programme (called BBTI) plus a sleep medication (eszopiclone), and 27 in a group that received the behavioural programme alone. By the end of the study, 22 and 21 participants respectively had completed it. The trial was measuring changes in sleep quality, insomnia severity, PTSD symptom severity, and depression symptom severity, as well as how consistently participants used a CPAP machine (a device used for breathing difficulties during sleep). The reported data shows the following changes in questionnaire scores from the start of the trial to six months later (on all these scales, a lower score means fewer or less severe symptoms, so a minus number means scores went down). For the main sleep quality measure (the PSQI, scored 0–21), the combination group's average score dropped by 5.25 points and the behavioural-programme-only group's dropped by 5.45 points. For insomnia severity (ISI, scored 0–28), the drops were 8.32 and 8.64 points respectively. For PTSD symptom severity (PCL-5, scored 0–80), the drops were 10.63 and 4.46 points. For depression symptoms (BDI-II, scored 0–63), the drops were 4.34 and 3.07 points. Regarding CPAP use, the reported data shows that 37.15% of participants in the combination group and 16.85% in the behavioural-programme-only group met the definition of consistent CPAP use (using the device for four or more hours a night over a 28-day period) at the six-month point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04143243 · results posted 8 October 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT04143243) enrolled 176 participants in total — 90 in a programme called "ACT on Life" and 86 in a comparison group called "Education, Resources, and Support." Of those, 83 and 77 participants respectively completed the study. The trial was designed to measure symptoms of depression, anxiety and stress, as well as how difficult veterans found it to readjust to civilian life after military service. It also tracked a range of other experiences, including post-traumatic stress symptoms, pain, and how well participants felt they were living in line with their own values. The reported data shows that, on the main depression, anxiety and stress scale (scored 0–63, where higher means more severe symptoms), the ACT on Life group scored 28.97 on average and the Education, Resources, and Support group scored 30.77. On the civilian reintegration difficulty scale (scored 0–4, where higher means greater difficulty), the scores were 2.296 and 2.395 respectively. For the secondary measures, the reported data shows average post-traumatic stress scores (0–80 scale) of 42.38 and 47.36; average pain severity scores (0–10 scale) of 5.77 and 5.87; a psychological flexibility measure (7–49 scale, higher meaning less flexibility) of 30.10 and 30.78; and a "living in line with personal values" score (10–100 scale, higher meaning greater alignment) of 48.80 and 51.54 — all for the ACT on Life and Education, Resources, and Support groups in that order. It is worth noting that the figures above appear to reflect scores at a single point in time as reported in the structured data, and no change-over-time or comparison figures were included in the data submitted to ClinicalTrials.gov, so those are not reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT05849454 · results posted 22 September 2025

    According to the results reported on ClinicalTrials.gov, this trial tested a program called "Messy Memories," which appears to be a digital intervention involving a memory processing module — a tool where participants could record and replay personal memories. The trial was designed as a feasibility study, meaning its main purpose was to find out whether the program could be practically delivered and whether people would engage with it, rather than to test whether it treated a specific condition. Of the 69 people initially considered, 45 were found eligible, 29 agreed to take part, 25 completed a starting visit, and 19 completed the full study. The reported data shows several feasibility measurements. Around 65% of screened people met the eligibility criteria, and approximately 64% of those eligible went on to enrol. Of the enrolled participants, about 66% recorded at least one memory using the memory processing module. On average, each participant accessed the memory processing module 5 times over the course of the study, and spent a reported average of around 57 minutes using it in total. When asked at the end of the study to rate how feasible the intervention felt to them (using a questionnaire scored from 1 to 5, where higher means more feasible), approximately 79% of participants gave a score of 4 or above. The reported data does not include outcome numbers for any clinical health measures — this trial was focused entirely on feasibility and engagement figures, so no data on symptoms or health changes was reported to ClinicalTrials.gov for this study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT05374408 · results posted 9 September 2025

    According to the results reported on ClinicalTrials.gov, this trial looked at a mobile phone app called BounceBack Now (BBN), which was designed for people who have experienced trauma. The study had two main aims: first, to get feedback on educational materials about the app from patients and behavioural health providers (mental health staff); and second, to test whether the app could realistically be used in a real-world healthcare setting. In total, 29 people took part across four groups — 5 patients and 2 behavioural health providers in the first aim's focus groups, and 12 patients and 10 staff/providers in the second aim. Of the 12 patients in the second aim, 6 completed the study. The reported data shows that in the first aim, small numbers of participants (ranging from 2 to 4 people per group across different discussion topics) took part in the "think aloud" interviews about the educational materials. For the second aim, the reported numbers across interview topics ranged from 1 to 10 participants per group. When it came to the app itself, 6 out of the patients reported downloading and using the app over the 6-week study period. Usability of the app was measured using an 18-item questionnaire where scores can range from 18 (lowest) to 126 (highest) — the reported average score was 113.8 out of 126. A separate "burden" questionnaire measured how much trouble or stress participants felt using the app, with scores ranging from 0 (not at all) to 80 (extremely) — the reported average score was 4.17 out of 80. It is worth noting that this was a small study involving a limited number of participants, and the results are based largely on interviews and questionnaire scores rather than clinical health outcomes. The reported data describes how participants responded to the app and its materials, not whether the app produced any particular health result. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04999852 · results posted 5 September 2025

    According to the results reported on ClinicalTrials.gov, this trial looked at whether adding a listening-based program called the Safe and Sound Protocol (SSP) to regular psychotherapy made a difference for people with trauma-related difficulties. A total of 45 participants took part — 32 in the group that received psychotherapy combined with SSP, and 13 in the group that received psychotherapy alone (treatment as usual). Of those who started, 19 from the SSP combination group and 12 from the psychotherapy-only group completed the trial. The trial measured changes in PTSD symptoms and anxiety symptoms as its main outcomes, and also tracked some body-based measures related to how the nervous system responds to stress. The reported data shows that, on average, participants in the psychotherapy-plus-SSP group reported a decrease of 9.9 points on the PTSD symptom scale (which runs from 0 to 80, where lower scores mean fewer symptoms), while the psychotherapy-only group reported an average decrease of 2.3 points. For anxiety symptoms (measured on a 0–21 scale), the reported average decrease was 1.9 points in the SSP group and 0.8 points in the psychotherapy-only group. For a body-awareness questionnaire measuring nervous system-related sensations, the SSP group reported an average decrease of 1.7 points compared with 0.1 points in the other group. These are changes from the start of the trial to its end — they tell us what shifted on average within each group, not how the two groups compare statistically. The reported data also shows some measurements taken only in the SSP group related to heart activity during different body positions (lying down, sitting, standing). Heart period — the time between heartbeats, measured in milliseconds — decreased on average by 99.8 ms, 90.0 ms, and 70.2 ms across the three positions. A measure of heart rhythm variation linked to the calming part of the nervous system also showed changes of −0.35, −0.43, and −0.04 (in the units used by the study). These were described by the researchers as measures of how the body's automatic stress-response system may be changing, rather than direct measures of symptoms. No data was reported for these heart-related measures in the psychotherapy-only group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT05419999 · results posted 29 May 2025

    According to the results reported on ClinicalTrials.gov, this trial enrolled 25 people in total — 12 in a group that received transcranial direct current stimulation (tDCS, a mild electrical brain stimulation) combined with a talking therapy called Written Exposure Therapy (WET), and 13 in a group that received a sham (inactive/pretend) version of the stimulation combined with the same talking therapy. Twenty-four of the 25 participants completed the study. The trial was measuring whether it was practical to run this combination treatment, and tracking scores on several questionnaires that assess symptoms of post-traumatic stress (PTSD), depression, and anxiety before and after treatment. The reported data shows that on the main PTSD self-report questionnaire (scored 0–80, where lower means fewer symptoms), the tDCS-plus-therapy group started with an average score of about 44 and ended with about 23, while the sham-plus-therapy group started at about 43 and ended at about 25. On a clinician-rated PTSD interview (also 0–80), the tDCS group went from roughly 36 down to about 15, and the sham group went from roughly 35 down to about 16. All 12 completers in each group finished all five therapy sessions, which was the trial's key feasibility measure. The reported data shows that on the depression questionnaire (0–27), both groups started around 15–16 and finished around 11. On the anxiety questionnaire (0–21), both groups started around 15 and finished around 10. It is important to note that this was a small, early-phase trial primarily designed to test whether the study design was practical to run, not to draw firm conclusions about whether one treatment is better than another. The numbers above describe what was recorded in both groups, but the trial was not large enough to determine whether any differences between the groups are meaningful. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02512445 · results posted 9 May 2025

    According to the results reported on ClinicalTrials.gov, this trial enrolled 145 people in total — 74 in a group receiving Trauma Informed Guilt Reduction Therapy and 71 in a group receiving Supportive Care Therapy. Of those, 48 and 50 people respectively completed the study, meaning a number of participants in both groups did not finish. The trial was measuring changes in feelings of guilt related to traumatic experiences, as well as related measures including PTSD symptom severity, depression, shame, quality of life, and general psychological distress. The reported data shows that, for the primary measure — a guilt severity scale scored from 0 to 4, where higher means more severe guilt — both groups started at an average score of 2.5. At the end of the study, the Trauma Informed Guilt Reduction Therapy group's average score was reported as 1.6, while the Supportive Care Therapy group's average score was reported as 2.2. For the secondary measures, both groups also started at similar levels across all scales. The reported data shows that on the PTSD symptom scale (0–80), scores moved from 38.2 to 23.3 in the guilt therapy group, and from 38.6 to 30.9 in the supportive care group. On the depression scale (0–27), scores moved from 15.1 to 9.8 and from 14.4 to 12.5 respectively. On the shame scale (0–120), scores moved from 51.4 to 37.4 and from 49.6 to 41.9. For quality of life (0–100, where higher is better), scores moved from 43.7 to 48.3 and from 44.5 to 44.4. On the general distress scale (0–72), scores moved from 53.1 to 47.3 and from 54.0 to 49.0. It is worth noting that the reported data shows score changes at the group level only; individual experiences within the trial are not captured in these numbers, and a substantial number of participants did not complete the study in both groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT05168267 · results posted 8 April 2025

    According to the results reported on ClinicalTrials.gov, this trial looked at delivering a talking therapy called Cognitive Processing Therapy (CPT) — a structured program designed for people who have experienced trauma — inside correctional facilities. A total of 69 people started the intervention: 35 women at one facility and 34 men at another. The trial was measuring three main things: how many people stuck with the program from start to finish, how much self-reported trauma (PTSD) symptoms changed during the program, and how satisfied participants were with the therapy. The reported data shows that when it comes to attendance, 31 of the 35 women and 32 of the 34 men completed all offered sessions. For PTSD symptoms, participants filled out a questionnaire (scored from 0, meaning no symptoms, to 80, meaning very severe symptoms) before and after the program. The reported data shows an average decrease in scores of around 19 points for women and around 13 points for men — with lower scores meaning fewer reported symptoms. Regarding satisfaction, participants completed a questionnaire scored from 8 to 32, where higher numbers mean greater satisfaction; women reported an average score of about 28.5 and men about 25.7 out of 32. The reported data also shows that, as secondary measures of how practical the program was to run, 43 women and 36 men were found eligible to take part after screening, and 31 women and 30 men attended at least 75% of all sessions offered. These figures were collected to help assess whether running this kind of program in a correctional setting was workable. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03068325 · results posted 8 April 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT03068325) involved a single group of participants called "EAT-PTSD." A total of 63 people started the study, 58 completed it, and 5 did not finish. The trial was measuring changes in post-traumatic stress disorder (PTSD) symptoms over 8 weeks, using a standardised clinical interview tool called the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5). This scale runs from 0 to 80, where a higher number means more severe PTSD symptoms. The reported data shows that, on average, participants scored 38.6 on the CAPS-5 scale at the start of the study (before any treatment began), and 26.9 at the 8-week point. This means the average score on this particular symptom-severity scale was numerically lower at 8 weeks compared to the beginning of the study. No secondary outcome measures were included in the submitted results data. It is also worth noting that this trial had only one group — there was no separate comparison or "control" group reported in this data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04597190 · results posted 26 March 2025

    According to the results reported on ClinicalTrials.gov, this trial enrolled 700 people in total across three treatment groups. One group (169 people) started on an SSRI medication and then had a talking therapy called WET added on top; a second group (179 people) started on an SSRI and then switched to a different type of antidepressant called an SNRI; and a third group (352 people) started with WET talking therapy and then switched to an SSRI. The trial was measuring PTSD symptom levels, mental health-related quality of life, and depression symptom levels across these groups. By the end of the study, 590 of the 700 participants had completed the trial. The reported data shows that PTSD symptoms were measured using a self-reported questionnaire scored from 0 to 80, where higher numbers mean more severe symptoms. At the first measurement point, scores were 39.3, 38.6, and 40.5 for the three groups respectively — suggesting broadly similar starting points. At a later measurement point, the reported scores were 49.3, 42.1, and 44.5 for the same three groups. For mental health-related quality of life (scored 0–100, where higher is better), the reported data shows scores of 34.7, 34.1, and 32.9 at the first time point, and 29.4, 32.0, and 31.7 at the later time point. For depression symptoms (scored 0–27, higher meaning worse), the reported figures were 12.6, 12.3, and 13.3 at the first time point, and 14.3, 13.4, and 14.6 at the later time point. The data does not specify which time points these measurements correspond to, so direct comparisons between them should be treated with caution. It is worth noting that the reported results data does not include information about statistical comparisons between the groups, so it is not possible from these numbers alone to draw conclusions about whether differences between groups were meaningful. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT06081309 · results posted 19 March 2025

    According to the results reported on ClinicalTrials.gov, this trial enrolled 30 adults who received a brain stimulation treatment called TMS (Transcranial Magnetic Stimulation) that was personalised using EEG (a recording of the brain's electrical activity). All 30 participants completed the study — none dropped out. The trial was looking at unwanted events (called adverse events) that occurred during the study, as well as changes in PTSD symptom scores on a standard checklist called the PCL-5, which runs from 0 to 80, where a lower number means fewer or less severe symptoms. The reported data shows that across all participants, a total of 26 adverse events were recorded during the study. Of these, 14 out of 30 participants experienced at least one adverse event. Breaking those 26 events down further: 3 were reported as moderate in severity and 2 as severe (the remainder are not separately detailed in the submitted data); 9 were considered possibly or definitely related to the treatment, while 17 were reported as not related; none were classified as serious adverse events; and none required follow-up treatment or intervention. Regarding PTSD symptoms, the reported data shows the average PCL-5 score at the start of the study was 52.2, and by the end it was 22.9 — a reported average drop of 29.3 points on that 0–80 scale. It is worth noting this trial had no comparison group (such as a placebo group), so all results come from a single group of participants who received the active treatment. The reported data does not include longer-term follow-up figures beyond the study period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT05305235 · results posted 5 March 2025

    According to the results reported on ClinicalTrials.gov, this trial involved 60 people in total — 27 assigned to a program called "RISE Guide" and 33 assigned to a "Relaxation Control" group. The trial was testing whether it was practical and acceptable to run a study using these two approaches, rather than measuring whether a treatment cured or treated a condition. By the time the study ended, 19 people in the RISE Guide group and 17 in the Relaxation Control group had completed it, meaning a notable number of participants did not finish in both groups. The reported data shows that participants in the RISE Guide group scored an average of 57.53 out of 70 on a scale measuring how acceptable and easy to stick with they found the treatment (higher scores mean more acceptable). On a separate scale measuring how much participants believed the treatment would help them and how credible they found it — scored out of 56 — the RISE Guide group averaged 22.85 and the Relaxation Control group averaged 18.61. A survey about how often participants logged in and how interested they were (where lower scores mean greater use and acceptability) returned averages of 12.45 for RISE Guide and 10.89 for Relaxation Control. The reported data also shows that on average, about 2 participants per month were successfully enrolled and randomly assigned to a group across the whole study. For following up with participants at 7 weeks, 85% of the RISE Guide group and 67% of the Relaxation Control group were retained; at 6 months, those figures were 70% and 52% respectively. Finally, the reported data shows zero unexpected adverse events were recorded in either group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04889755 · results posted 17 February 2025

    According to the results reported on ClinicalTrials.gov, this trial — called SibACCESS — enrolled a very small number of participants: 3 siblings and 3 parents. All 6 people who started the study completed it. The trial was looking at how siblings of children with cancer were faring emotionally and psychologically, using a range of questionnaires filled out by both the siblings themselves and their parents. The reported data shows the following scores across the questionnaires used. On the main measure — the Child PTSD Symptom Scale, which tracks stress symptoms related to traumatic experiences on a scale of 0 to 80 (where higher means more symptoms) — the sibling group recorded an average score of 15.3. On the Strengths & Difficulties Questionnaire, which measures general emotional and behavioural difficulties on a scale of 0 to 40 (higher meaning more difficulties), siblings reported an average of 16.3 and parents reported an average of 13.0 for their children. The Sibling Perception Questionnaire, scored from 18 to 72 (higher meaning more negative adjustment), showed an average of 24.7 from siblings and 36.5 from parents. For siblings only, the Coping Self-Efficacy Scale (0–260, higher meaning more confidence in coping) returned an average of 188.0; the Emotional Avoidance Scale (0–68) returned an average of 11.7; and the Perceived Filial Self-Efficacy Scale (16–112, higher meaning stronger family-role confidence) returned an average of 89.7. No scores were reported for parent participants on the measures designated as sibling-only. It is worth noting that with only 3 participants in each group, these numbers reflect a very small pilot-scale study, and the reported data does not include any comparison group or before-and-after figures, so the numbers above represent single time-point averages only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT04937504 · results posted 14 February 2025

    According to the results reported on ClinicalTrials.gov, this trial enrolled 60 people in total — 31 in a group receiving an in-person programme called STAIR-PC, and 29 in a group using an online version called WebSTAIR. Both programmes are designed to support people experiencing symptoms of post-traumatic stress (PTSD). The trial was measuring three main things: changes in PTSD symptom scores over time, how many people stuck with the programme (called "feasibility"), and how satisfied participants were with it. A number of additional measures tracked general mental wellbeing, difficulties managing emotions, and distress related to experiences of discrimination. Assessments were taken at the start of the trial, at 15 weeks, and at around 9 months. The reported data shows that PTSD symptom scores (measured on a scale of 0–80, where higher means more severe) started at around 61 for the STAIR-PC group and 58 for the WebSTAIR group. By 15 weeks these had dropped to approximately 39 and 36 respectively, and by 9 months to around 28 for STAIR-PC and 36 for WebSTAIR. For the feasibility measure — how many people completed at least 90 minutes of the programme by 15 weeks — 24 out of 31 did so in the STAIR-PC group compared with 12 out of 29 in the WebSTAIR group. Satisfaction scores (on a scale of 1–32, higher being more satisfied) were reported as approximately 26.6 for STAIR-PC and 23.7 for WebSTAIR at 15 weeks, remaining similar at 9 months. The reported data also shows reductions over time in scores measuring general psychological distress and difficulties with emotions in both groups, though the numbers at each time point differed between the two groups. For the discrimination-related trauma symptom scores, the reported figures varied across time points and groups, and the data does not clearly show a consistent pattern in either direction. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03841773 · results posted 6 February 2025

    According to the results reported on ClinicalTrials.gov, this trial (NCT03841773) looked at a tablet called TNX-102 SL (5.6 mg), placed under the tongue, compared to a placebo (a dummy tablet with no active ingredient) in people with PTSD. A total of 192 people took part — 93 in the placebo group and 99 in the TNX-102 group. The trial ran for 12 weeks and measured changes in PTSD symptom severity using several questionnaires and rating scales. The reported data shows the following numbers after 12 weeks of treatment. For the main measure — a PTSD symptom scale called the CAPS-5, which runs from 0 (no symptoms) to 80 (most severe) — scores in the placebo group fell by an average of 18.5 points from their starting level, while scores in the TNX-102 group fell by an average of 20.7 points. On a separate clinician-rated severity scale (scored 1–7, where higher means more unwell), the placebo group's scores dropped by an average of 1.5 points and the TNX-102 group's by 2.0 points. A self-reported scale measuring how much symptoms disrupted daily life (scored 0–30, where higher means more disruption) showed an average drop of 7.6 points in the placebo group and 9.4 points in the TNX-102 group. Finally, a sleep disturbance measure showed an average drop of 9.4 points in the placebo group and 13.0 points in the TNX-102 group — in both cases, a lower score indicates less sleep disturbance. It is worth noting that 29 people in the placebo group and 40 in the TNX-102 group did not complete the trial, which may affect how the numbers are interpreted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT05520190 · results posted 10 January 2025

    According to the results reported on ClinicalTrials.gov, this trial enrolled 42 participants in total, with 33 completing the study and 9 not completing it. The trial was designed to look at whether a program could influence deaf or hard-of-hearing people's willingness to seek professional help for behavioural health concerns (such as alcohol use). It measured things like participants' attitudes toward treatment, their sense of what others in their community thought about seeking help, how much control they felt they had over seeking treatment, and whether they actually went ahead and booked or attended a professional service. The reported data shows that out of all participants, 8 scheduled or attended at least one professional treatment service during the study. For the attitude questions — rated on a scale of 1 to 7, where higher numbers mean more positive attitudes — the reported average score moved from 4.93 before the program to 5.40 afterwards. The "subjective norm" score (how participants perceived their community's views on seeking help) moved from 5.18 to 5.51 on the same scale. The score measuring how much control participants felt they had over seeking treatment was 6.10 beforehand and 6.14 afterwards. Their intention to seek treatment, rated on a scale of 3 to 21, went from an average of 4.62 to 4.92. As an additional measure reported after the study was completed, average drinks per day in the past month was recorded as 1.42 at the start and 0.88 at the end. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT05938816 · results posted 5 November 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT05938816) compared two group programmes — Mindfulness-Based Stress Reduction (MBSR) and a Health and Wellness Education programme — in people with PTSD (post-traumatic stress disorder). The trial was primarily designed to explore whether MBSR was feasible and acceptable to participants, meaning it was looking at practical questions like what got in the way of people completing the programme and whether participants felt the content was relevant to their lives. Secondary measurements included self-reported questionnaires about psychological resilience and PTSD symptoms, as well as physical measurements of blood pressure responses during a stress task. The reported data shows that no participant numbers have been recorded against any of the study milestones — the number of people who started, completed, or did not complete the trial is listed as zero for both groups. Additionally, no numerical results have been submitted for any of the outcome measures, whether the primary qualitative interviews or any of the secondary questionnaires and physical measurements. This means the actual findings from the trial — what participants said in interviews, their resilience scores, their PTSD symptom scores, and their blood pressure readings — have not been reported in the structured data available on ClinicalTrials.gov at this time. In plain terms, while the trial was registered and its intended measurements are described, the results data was not reported for this trial as of the information available. It is not possible to describe what the trial found, because those figures were not submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02774642 · results posted 8 October 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT02774642) enrolled 94 people in total — 52 in one group called CBTI-PE (a combination of cognitive behavioural therapy for insomnia and prolonged exposure therapy) and 42 in a comparison group called Hygiene-PE (sleep hygiene education combined with prolonged exposure therapy). Of those, 43 and 35 participants respectively completed the study. The trial was measuring two main things over time: changes in PTSD (post-traumatic stress disorder) symptom severity, and changes in sleep efficiency (the proportion of time in bed actually spent asleep). The reported data shows that for PTSD symptoms — measured on a scale of 0 to 80 where lower means less severe — the CBTI-PE group had scores of 25.74 and 28.59 recorded at different timepoints, while the Hygiene-PE group had scores of 28.18 and 24.93. For sleep efficiency — measured as a percentage, where higher is considered better — the CBTI-PE group recorded 88.71% and 86.46% at different timepoints, compared with 78.44% and 78.23% for the Hygiene-PE group. The reported data also shows secondary measures including insomnia severity (scale 0–28, lower is less severe), quality of life across several areas, pain, and participant satisfaction with therapy, though the full breakdown of timepoints for some of these measures was not always clearly labelled in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04889664 · results posted 8 October 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT04889664) looked at a combination of ketamine infusions and a talking-based approach called Written Exposure Therapy (WET) for people with PTSD. A total of 16 people went through the initial screening phase, 14 of those moved on to receive the study treatment, and 13 completed the full treatment period. The reported data shows that the trial measured PTSD symptom severity using a tool called the CAPS-5 (Clinician Administered PTSD Scale for DSM-5). This is a structured interview where a clinician rates the frequency and intensity of a person's PTSD symptoms. Scores on this scale can range from 0 to 80, with higher numbers meaning more severe symptoms. According to the results reported on ClinicalTrials.gov, participants had an average score of 41.6 at the start of the study (before treatment began), and an average score of 20.8 at the 12-week follow-up point. No other outcome measures were included in the submitted results data. It is worth noting that this trial had only one group — everyone received the same combination treatment — so there was no separate comparison or control group reported in the submitted data. The reported data shows only the numbers for the group as a whole at two points in time. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04236986 · results posted 26 September 2024

    According to the results reported on ClinicalTrials.gov, this trial enrolled 34 people across two groups: 18 people who had experienced trauma but did not have PTSD (the "healthy control" group), and 16 people who had experienced trauma and did have PTSD. Of those, 15 people in each group completed the study. The trial was measuring activity of a protein in the brain called TSPO — a marker linked to brain inflammation — using a specialised brain scan technique. Participants were scanned twice: once at their normal baseline, and once after receiving a small dose of a substance called LPS (lipopolysaccharide), which is used in research to temporarily trigger a mild inflammatory response in the body, so researchers could see how the brain responded. The reported data shows that, at baseline, the TSPO measurement (recorded in units called mL/cm³, which reflect how much of the scan tracer the brain was taking up) ranged across four brain regions. For the trauma-exposed group without PTSD, the reported values across brain regions were approximately 4.89 to 5.33 mL/cm³, while for the PTSD group the values ranged from approximately 4.38 to 5.33 mL/cm³. After the LPS dose, the reported values were higher in both groups: approximately 6.82 to 7.73 mL/cm³ in the trauma-exposed group without PTSD, and approximately 5.66 to 7.73 mL/cm³ in the PTSD group. For the secondary outcomes — which looked at attention speed and visual learning using computerised tasks — the reported data shows the two groups recorded differing scores at baseline and after LPS, though some of the baseline attention figures appear unusually different between groups and the data as submitted was not accompanied by explanatory notes. The reported data also includes scores for visual learning (how well participants correctly identified repeated images), with baseline scores of approximately 0.93 for the trauma-exposed group without PTSD and 1.01 for the PTSD group, and post-LPS scores of approximately 0.98 and 0.91 respectively — where higher numbers reflect a greater proportion of correct responses. These numbers are as submitted by the trial sponsor and no further breakdown or statistical comparisons were included in the structured data provided to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT05187364 · results posted 24 September 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT05187364) involved a single group called the "COPE Therapy Arm." Four participants started the study, but only one completed it, and three did not finish. The trial was looking at how practical and usable a piece of equipment was — specifically, whether participants could turn it on and off within five minutes, and how easy and acceptable they found it to use overall. The reported data shows that, of the participants assessed, two were recorded as being able to turn the equipment on and off within five minutes. The trial had set a target of 80% of participants achieving this. Separately, usability was measured using a standard questionnaire called the System Usability Scale, which runs from 0 to 100 — a higher number means people found the system easier and more acceptable to use, and a score of 68 or above is generally considered acceptable. The reported average score for the group was 90 out of 100. It is worth noting that, given only a very small number of people took part and most did not complete the study, these numbers come from a very limited sample. No other outcome measures were included in the submitted results data. Secondary outcomes, if any were planned, were not reported in the data available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT04163341 · results posted 19 September 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT04163341) enrolled 60 people in total — 30 in a group receiving the CETA (Common Elements Treatment Approach) counselling protocol, and 30 in a group receiving enhanced usual care. The trial was primarily designed to test whether the study itself was practical to run — looking at how easy it was to recruit participants, how satisfied participants were with the care they received, and how consistently the counsellors delivered the CETA program as intended. It also collected information on several HIV-related measures as secondary outcomes. The reported data shows that 92 people needed to be approached to enrol the 60 participants. On the Client Satisfaction Questionnaire (a satisfaction survey scored from 8 to 32, where higher means more satisfied), the CETA group scored 29.3 out of 32 — noting that no score was reported for the enhanced usual care group in the submitted data. For counsellor fidelity (how closely the counsellors stuck to the CETA program, rated 0–4), the two CETA counsellors scored 3.3 and 3.0 respectively. Regarding the secondary measures, the reported data shows that for HIV viral load suppression (a measure of how much virus is detectable in the blood), the numbers varied across two separately reported timepoints — and for appointment attendance, 22 participants in each group met the definition of being engaged in care over the 12-month follow-up period. It is worth noting that this was a feasibility study, meaning its primary purpose was to assess whether a larger trial could be conducted, rather than to draw firm conclusions about any treatment. Some data points — such as the satisfaction score for the enhanced usual care group — were not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02856412 · results posted 19 September 2024

    According to the results reported on ClinicalTrials.gov, this trial enrolled 84 veterans in total — 41 in a group exercise programme (called the Veterans Group Exercise arm) and 43 in a programme called Illness Management and Recovery. Of those who started, 30 and 34 participants respectively completed the study, meaning 11 and 9 did not finish. The trial was measuring two main things: PTSD symptom severity, using a clinician-administered rating scale called the CAPS-5 (scored 0–80, where higher numbers mean more severe symptoms), and psychological quality of life, using a World Health Organization questionnaire called the WHOQOL-BREF (scored 0–100, where higher numbers mean better psychological wellbeing). The reported data shows that, at the end of the study, the Veterans Group Exercise group had an average CAPS-5 score of 24.4, compared with 22.0 in the Illness Management and Recovery group. For psychological quality of life, the reported average scores were 41.5 for the exercise group and 45.2 for the Illness Management and Recovery group. The reported data also shows results from several secondary measures. On a mindfulness questionnaire (FFMQ — Observing subscale, range 8–40), average scores were 22.2 and 26.4 respectively. On a physical activity questionnaire, scores were very similar: 44.2 versus 43.8. On a self-reported PTSD checklist (PCL-5, range 0–80), average scores were 36.3 and 39.9. On a general psychological symptoms checklist (SCL-90-R, range 0–4), both groups reported virtually the same average score of 1.14 and 1.13. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03759223 · results posted 27 August 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT03759223) involved 50 people in total across three groups: 19 were randomly assigned to receive an online problem-solving therapy called E-PST, 19 were randomly assigned to a control group, and 12 chose to join the E-PST group outside of the random assignment process. The trial was measuring psychological distress, self-reported thinking and memory concerns, and mood symptoms in people who had experienced a brain injury. Not everyone finished the study — 16 of the 19 randomised E-PST participants, 14 of the 19 control participants, and 7 of the 12 non-randomised E-PST participants completed it. The reported data shows the main thing being measured was a psychological distress score (called the BSI-18 Global Severity Index T-score), where a score of 50 represents an average healthy person and higher scores indicate more distress. At the start, all three groups scored in the mid-60s (around 64–67). By the end of the study, the randomised E-PST group's score was reported as approximately 61, the randomised control group's score was approximately 62, and the non-randomised E-PST group's score was reported as 57. For mood symptoms (PHQ-9, scored 0–27 with lower meaning fewer symptoms), the randomised E-PST group went from about 12 at the start to about 9 at the end, while the control group's score stayed around 11–12. The reported data also shows scores from several thinking and memory tests across all time points. On measures of self-reported cognitive concerns and abilities, both groups scored below the average healthy population benchmark of 50 throughout the study. Memory and attention test scores were similarly below that healthy-population average for both groups at all time points, with no large differences between the groups apparent in the numbers as reported. Some data points for the non-randomised group were not reported for the secondary measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03283163 · results posted 14 August 2024

    According to the results reported on ClinicalTrials.gov, this trial enrolled 23 people who had both chronic pain and PTSD (post-traumatic stress disorder). All participants were in a single group. The trial was measuring changes in three main areas: PTSD symptom levels (using a questionnaire called the PCL-5), how much pain interfered with daily life (using a questionnaire called the WHY-MPI), and a thinking pattern called "pain catastrophising" — which refers to how much a person dwells on, worries about, or feels helpless about their pain. The trial also measured levels of two naturally occurring hormones in the blood (called ALLO and PA) that are associated with stress and pain responses. Of the 23 people who started, 12 completed the study and 11 did not complete it. The reported data shows the following changes from the start of the study to week 13. On the PCL-5 PTSD symptom scale (which runs from 0 to 80, where higher numbers mean more severe symptoms), the reported average change was 15.64 points. On the pain interference scale (which runs from 0 to 6, where higher numbers mean greater interference), the reported average change was 2.56 points. On the pain catastrophising scale (which runs from 0 to 52, where higher numbers mean more catastrophising thinking), the reported average change was 13.92 points. The reported data shows that after 12 weeks, average resting blood levels of ALLO and PA were 5,855.33 pg/ml, and average peak levels (measured during an exercise test) were 4,062.50 pg/ml. No baseline comparison figures for the blood hormone levels were included in the reported data, so it is not possible to describe the change in those measures from the start of the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02803125 · results posted 1 August 2024

    According to the results reported on ClinicalTrials.gov, this trial involved 34 veterans in total — 18 in a group that received a specially developed psychosocial (emotional and social wellbeing) intervention, and 16 in a support group used for comparison. By the end of the trial, 13 people in the intervention group and 12 in the comparison group had completed the study, meaning 5 and 4 participants respectively did not finish. The trial was measuring things like social functioning (how well people got along in romantic relationships, with family, and with friends), overall quality of life, and general physical and mental health and wellbeing. The reported data shows the following end-of-study average scores. On the social functioning questionnaire — where higher numbers mean more difficulty — the intervention group scored 24.1 for romantic relationships, 12.2 for family, and 12.5 for friendships/socialising, while the comparison group scored 15.7, 17.5, and 15.4 respectively. For overall quality of life (scored on a scale where 50 represents an average reference population), the intervention group averaged 34.69 and the comparison group averaged 33.6 — both below the population average of 50. On the general health survey (also scored against a population average of 50), the intervention group averaged 44.59 for physical health and 42.08 for mental health, compared to 40.37 and 37.44 in the comparison group. The reported data shows scores across all measures that were generally below the population average of 50 for both groups at the time these results were recorded. It is important to note that this was a small trial, and the results as presented here are the final scores only — information about how scores may have changed over the course of the trial was not included in the data reported to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02657317 · results posted 29 July 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT02657317) involved 103 participants in total — 50 in the FORT-A group and 53 in a "Treatment As Usual" comparison group. The trial was measuring changes in a self-reported back pain disability questionnaire called the Oswestry Disability Index (ODI). This questionnaire asks people about how much pain limits their daily life across ten areas, producing a score from 0 to 100, where a higher score means greater perceived disability. Of those who started, 45 in the FORT-A group and 50 in the Treatment As Usual group completed the study. The reported data shows that at the start of the study, both groups had similar average ODI scores — 48.6 for the FORT-A group and 45.1 for the Treatment As Usual group, which would place both roughly in the "Severe" disability range on the questionnaire's categories. Across the subsequent measurement points reported, the FORT-A group's average scores were recorded as 38.3, then 37.6, and finally 37.9 — moving into the "Moderate" disability range. The Treatment As Usual group's scores across those same time points were reported as 47.8, then 47.1, and finally 45.7, remaining in or near the "Severe" range throughout. The trial did not appear to report secondary outcome measures in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02391402 · results posted 8 July 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT02391402) enrolled 73 people in total — 39 in a group receiving an intervention called CABA and 34 receiving what was described as "Treatment as Usual" (TAU). Of those, 30 people in the CABA group and 26 in the TAU group completed the study. The trial was measuring PTSD (post-traumatic stress disorder) symptom levels and memory performance at the start of the study and again at 14 weeks, using three different assessment tools. The reported data shows that PTSD symptoms were measured using two tools. On the clinician-rated scale (scored 0–136, where higher means more severe), both groups started at similar levels (CABA: 40.62, TAU: 40.53). At 14 weeks, the reported scores were 33.32 for the CABA group and 37.35 for the TAU group. On the self-reported checklist (scored 0–80, where higher means more distress), starting scores were again similar (CABA: 50.15, TAU: 51.21), and at 14 weeks the reported scores were 44.92 for the CABA group and 52.17 for the TAU group. For memory, which was measured using a standardised score where 50 is the average for the general population, both groups started below average (CABA: 35.05, TAU: 33.74). At 14 weeks, the reported scores were 45.33 for the CABA group and 37.30 for the TAU group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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  • NCT03979040 · results posted 3 July 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT03979040) compared two types of group therapy for people dealing with emotional and psychological difficulties. One group received "Group Transdiagnostic Behavior Therapy" (G-TBT), a single approach designed to address a range of mental health conditions at once, while the other received "Group Disorder-Specific Therapies" (G-DSTs), which are therapies tailored to particular conditions. A total of 125 people started in the G-TBT group and 118 in the G-DST group. However, a notable number did not complete the trial — 56 in the G-TBT group and 72 in the G-DST group did not finish. The trial measured three things at multiple time points using standard questionnaire-based scales. The reported data shows scores on a depression measure (DASS-Depression, scored 0–21, higher meaning more severe) started at 10.6 for G-TBT and 11.0 for G-DST, and at the later time points moved to 8.8 and 8.1, then 8.5 and 9.9 respectively. For a measure of how much illness interfered with daily life (IIRS, scored 1–91, higher meaning more interference), starting scores were 62.6 and 59.3, moving to 59.0 and 52.0, then 53.8 and 52.9. For a measure of post-traumatic stress symptoms (PCL-5, scored 0–80, higher meaning more severe), starting scores were 43.4 and 40.0, moving to 40.3 and 33.9, then 36.9 and 35.9. The reported data shows that scores on all three measures were lower at later time points for both groups, though the trial results as submitted do not include statistical comparisons between the groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT04506294 · results posted 26 June 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT04506294) involved a total of 320 children, split into two groups: 214 in the "eScreen" group (who used a touch-screen digital tool to report their pain and stress symptoms) and 106 in the "usual care" group. Of those who started, 128 eScreen participants and 84 usual care participants completed the study. The trial was looking at whether scores recorded by the eScreen tool at the start of a child's hospital or clinic visit could predict how much pain and post-traumatic stress symptoms (distressing reactions that can follow a frightening event or injury) the child would have six weeks later. It also looked at whether parents in the eScreen group felt more confident managing their child's recovery at home compared to parents in the usual care group. The reported data shows the following numbers for the eScreen group's predictive accuracy, expressed as an AUC (Area Under the Curve — a number between 0 and 1 where 0.5 means no better than chance and 1.0 means perfect prediction): the eScreen pain score's ability to predict significant pain interference at six weeks was reported as 0.756; its ability to predict whether a child would meet criteria for post-traumatic stress disorder at six weeks was reported as 0.822; and its ability to predict significant impairment from post-traumatic stress symptoms was reported as 0.691. The reported data shows that the AUC figure for the eScreen pain score predicting significant pain severity (rated 6 or above on a 0–10 scale) at six weeks was not reported in the submitted data. For parent confidence in managing their child's symptoms and recovery (scored on a scale of 5 to 45, where higher means more confident), the eScreen group reported an average score of 39.6 and the usual care group reported 38.9. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02277704 · results posted 20 June 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT02277704) enrolled 245 adults across three groups: 94 received a placebo (dummy treatment), 101 received a lower dose of TNX-102 SL (2.8 mg), and 50 received a higher dose (5.6 mg). The trial ran for 12 weeks and was measuring changes in PTSD symptom severity, sleep disturbance, overall functioning, and clinician-rated improvement. Not everyone finished — 67, 71, and 41 participants completed the study in each group respectively. The reported data shows that the main thing being measured was a PTSD symptom score called the CAPS-5 (which runs from 0 to 80, where lower numbers mean fewer symptoms). After 12 weeks, all three groups showed a reduction in their scores from where they started: the placebo group's average score dropped by 17.0 points, the 2.8 mg group's dropped by 19.2 points, and the 5.6 mg group's dropped by 21.5 points. For sleep disturbance (measured on a scale where lower scores mean less disruption), the placebo group's average score fell by 7.9 points, compared to 11.1 points in the 2.8 mg group and 11.0 points in the 5.6 mg group. On a disability scale (0–30, where lower means less impairment), average scores fell by 6.4 points for the placebo group, 7.9 points for the 2.8 mg group, and 8.7 points for the 5.6 mg group. The reported data also shows that a clinician rated each participant's overall improvement on a 1–7 scale, and counted how many people scored a 1 ("very much improved") or 2 ("much improved") at week 12. That count was 41 participants in the placebo group, 48 in the 2.8 mg group, and 31 in the 5.6 mg group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03256227 · results posted 14 June 2024

    According to the results reported on ClinicalTrials.gov, this trial involved 128 people in total — 64 in each of two groups. One group received a version of a talking therapy for post-traumatic stress (called Prolonged Exposure) that included family support, while the other group received the standard version of the same therapy without family involvement. The trial was measuring how many therapy sessions participants actually attended, and also tracked their self-reported PTSD symptom levels using a standard questionnaire. The reported data shows that, on average, people in the family-supported group attended approximately 6.77 sessions, compared to approximately 5.56 sessions in the standard group. In terms of who completed the study, 36 out of 64 people finished in the family-supported group, while 25 out of 64 finished in the standard group — meaning a notable number of participants did not complete the trial in either group. For the PTSD symptom questionnaire (which runs from 0 to 80, with higher numbers meaning more symptoms reported), the family-supported group had an average score of 51.56 and the standard group had an average score of 53.79. It is worth noting that these scores appear to reflect a single time point; change over time was not reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03906240 · results posted 13 June 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT03906240) enrolled 48 people in total — 24 in a "Moral Elevation Intervention" group and 24 in a "No Intervention" group. By the end of the study, 19 people in the intervention group and 23 in the no-intervention group had completed the trial. The trial was measuring whether a moral elevation intervention — an approach involving exercises aimed at producing a sense of being uplifted by witnessing goodness in others — was acceptable and satisfying to participants, and also tracked scores on several questionnaires related to post-traumatic stress (PTSD) symptoms, moral injury distress, and quality of life. The reported data shows that, for the intervention group only, acceptability was measured using a 9-item scale (scored 1–5, where above 3 suggests medium-to-high acceptability). Most individual item scores were above 3, ranging from roughly 2.75 to 4.00, with one item falling below the mid-point. On a separate 4-item satisfaction scale (scored 0–8, where above 4 suggests medium-to-high satisfaction), all four items scored above 4, ranging from approximately 4.64 to 6.22. A measure of how strongly participants experienced the "elevation" feeling during sessions (scored 0–4, where above 2 suggests medium-to-high levels) returned an average score of 1.63, which fell below that mid-point threshold. The reported data also shows scores on additional questionnaires tracked across both groups from the start to the end of the study. On the PTSD symptom questionnaire (scored 0–80, higher meaning more severe), the intervention group's average score went from 61.27 at the start to 43.56 at follow-up, while the no-intervention group went from 52.34 to 43.30. On the moral injury distress questionnaire (scored 17–85), the intervention group moved from 53.93 to 53.73, and the no-intervention group from 57.40 to 53.75. On the quality of life measure (multiple subscales each scored 0–100, higher meaning better), the reported data shows varying changes across subscales in both groups between the start and end of the study — no single summary figure was reported for the overall scale. No statistical comparison data between groups was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02869646 · results posted 18 April 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT02869646) looked at acupuncture as a potential approach for people with post-traumatic stress disorder (PTSD). A total of 92 people took part — 47 in a group receiving what the researchers called "verum acupuncture" (standard needle placement) and 45 in a "minimal needling" group (a comparison group where needles were placed differently, often used as a control). By the end of the trial, 39 people in the first group and 32 in the second group had completed the study, with 8 and 13 people respectively not finishing. The reported data shows that the main thing being measured was the change in PTSD symptom severity, using a structured interview tool called the CAPS-5. This tool scores symptoms on a scale from 0 (no symptoms) to 80 (most severe). The reported data shows that, after treatment, the verum acupuncture group had an average score of 22.6, while the minimal needling group had an average score of 29.1. The trial also measured something called "eyeblink startle potentiation" — a physical reflex linked to fear responses, recorded using sensors on the face. The reported data shows a 55.8% reduction in this startle response in the verum acupuncture group, compared to a 6.1% increase in the minimal needling group. No further detail about what these differences mean clinically was provided in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03260127 · results posted 1 April 2024

    According to the results reported on ClinicalTrials.gov, this trial (NCT03260127) enrolled 82 people in total — 42 in a group called CEFT-CPT and 40 in a group called WT-CPT. Both groups received a type of talking therapy known as CPT (Cognitive Processing Therapy), with the CEFT-CPT group also receiving additional cognitive exercises beforehand. The trial was measuring changes in executive functioning — that is, mental skills like planning, attention, and problem-solving — using six different tests administered before and after the programme. Of the 82 who started, 45 completed the full study (22 in CEFT-CPT and 23 in WT-CPT). The reported data shows the following score changes from before to after the programme. On the Wisconsin Card Sorting Test (where a lower score means a better result), the CEFT-CPT group recorded −2.69 and the WT-CPT group recorded −1.47. On the Paced Auditory Serial Addition Test (where a higher score means a better result), the scores were 14.32 and 10.88 respectively. On the Delis Kaplan Executive Function System (lower is better), the scores were −4.90 and −3.81. On the Behavior Rating Inventory of Executive Function self-report measure (lower is better), the scores were −6.52 and −3.50. On the WAIS-IV Digit Span test (higher is better), the scores were 1.03 and 0.31. Finally, on the N-Back attention task (higher is better), the scores were 0.04 and −0.01. The reported data does not include information about whether any differences between the two groups were considered statistically meaningful (i.e., unlikely to be due to chance). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03176953 · results posted 18 November 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT03176953) enrolled 100 people in total — 50 in each group. All participants received a talking therapy called Prolonged Exposure, but one group also took a medication called topiramate while the other took a placebo (a dummy pill with no active ingredient). The trial was measuring two things: changes in PTSD symptom severity (using a structured interview called the CAPS-5, scored from 0 to 80, where higher scores mean more severe symptoms) and changes in heavy drinking days (measured as a percentage of total days, where higher means more frequent heavy drinking). By the end of the study, 41 people in the topiramate group and 40 in the placebo group had completed the trial. The reported data shows that, for PTSD symptoms, both groups started at similar levels — the topiramate group averaged around 36.7 and the placebo group around 38.6 on the CAPS-5 scale. By the end of the study, the topiramate group's average score had dropped to approximately 21.0, while the placebo group's average score had dropped to approximately 29.9. For heavy drinking days, both groups also started at similar levels — around 53–54% of days involving heavy drinking. The reported data shows these figures dropped to around 10.8% for the topiramate group and 16.2% for the placebo group by the end of the study. It is important to note that these are averages across the groups as reported, and the data submitted to ClinicalTrials.gov does not include a full statistical breakdown of these comparisons. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT04471207 · results posted 31 October 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT04471207) involved 40 people in total across two groups. Twenty-nine participants were in a therapist-guided group that used a technology called "Intelligent Biometrics" alongside a talking therapy called Prolonged Exposure, while 11 participants were in a second group that used the same technology in a record-only mode without therapist guidance. The trial was measuring PTSD (post-traumatic stress disorder) symptom severity — how severe participants' PTSD symptoms were — using two different tools: one rated by a clinician (a trained health professional), and one filled out by the participants themselves. Of those who started, 18 people in the therapist-guided group and 5 in the record-only group completed the study. The reported data shows the following end-of-treatment scores on the two symptom measures. For the clinician-rated scale (called the CAPS-5, scored from 0 to 80 where lower numbers mean fewer or less severe symptoms), the therapist-guided group had an average score of 25.71, and the record-only group had an average score of 32.00. For the self-reported symptom checklist (called the PCL-5, also scored from 0 to 80 with lower scores meaning fewer symptoms), the therapist-guided group had an average score of 27.11, and the record-only group had an average score of 50.80. The data as reported does not include baseline (starting) scores, so it is not possible to say from this data alone how much scores may have changed over the course of the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03248167 · results posted 28 June 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT03248167) enrolled 30 people in total — 17 in the group receiving 600 mg of cannabidiol (CBD) daily and 13 in the placebo group (a dummy treatment with no active ingredient). Of those, 12 in the CBD group and 9 in the placebo group completed the study. The trial was measuring two main things in people with post-traumatic stress disorder (PTSD): how much alcohol they drank each day, and how severe their PTSD symptoms were, using a standard questionnaire called the PCL-5 (a self-rated scale from 0 to 80, where a higher number means more severe symptoms). The reported data shows that alcohol consumption — measured as number of drinks per day — was recorded at multiple points during the trial. At what appears to be the starting point, the CBD group reported approximately 4.5 drinks per day and the placebo group approximately 5.4 drinks per day. At a later time point, the CBD group reported approximately 1.9 drinks per day compared to approximately 2.2 for the placebo group. At another time point, the figures were approximately 2.5 (CBD) and 2.8 (placebo). For PTSD symptom scores, the reported starting scores were approximately 42 (CBD group) and 49 (placebo group). At a later point, scores were reported as approximately 19.9 (CBD group) and 29.9 (placebo group). At another time point, scores were approximately 26.6 (CBD group) and 26.9 (placebo group). The data does not specify which time points these measurements correspond to, so the exact timing of each reading cannot be confirmed from what was reported. It is worth noting that this was a relatively small trial, and the results as submitted do not include information about whether the differences between groups were statistically meaningful (that is, whether they were large enough to be considered more than random variation). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02849548 · results posted 2 June 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT02849548) involved 27 people in total — 13 received a medicine called suvorexant and 14 received a placebo (a dummy pill with no active ingredient). The trial was looking at whether suvorexant, taken alongside a type of talking therapy involving written accounts of a traumatic experience, had any effect on symptoms of post-traumatic stress disorder (PTSD). Of those who started, 11 in the suvorexant group and 12 in the placebo group completed the study, with 2 people in each group not finishing. The reported data shows that the main thing being measured was PTSD symptom severity, rated using a structured interview tool called the CAPS-5, which produces a score from 0 to 80 (higher scores mean more severe symptoms). At the two-week mark, the suvorexant group had an average score of 16.6 and the placebo group had an average score of 17.1 — very close to each other. The reported data also shows two secondary measurements taken during the last therapy session. One was a self-reported distress rating (from 0 to 100), adjusted against each person's starting level for that session; the suvorexant group reported an average of 18.9 compared to 40.3 for the placebo group. The other measurement was the rise in pulse rate (heartbeats per minute) above each person's starting level during the session; the suvorexant group showed an average rise of 5.3 beats per minute, compared to 4.8 for the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03033602 · results posted 24 May 2023

    According to the results reported on ClinicalTrials.gov, this trial involved 169 people — 85 in a group receiving Written Exposure Therapy (WET) and 84 in a group receiving a form of Cognitive Processing Therapy (CPT, Cognitive Only). Both are structured talking-based approaches used for post-traumatic stress disorder (PTSD). The trial was measuring PTSD symptom severity using a tool called the CAPS-5, which is a structured interview where trained clinicians assess symptoms. Scores on this scale range from 0 to 80, with higher scores meaning more severe symptoms. Not everyone finished the study — 65 people completed it in the WET group and 47 in the CPT group. The reported data shows CAPS-5 scores across what appear to be three time points for each group. For the Written Exposure Therapy group, the scores were reported as 31.55, then 29.59, then 27.77. For the CPT, Cognitive Only group, the scores were reported as 25.12, then 25.41, then 24.97. The data submitted to ClinicalTrials.gov does not specify which time points (for example, start of the study, mid-point, or end) these three measurements correspond to, so a direct before-and-after comparison cannot be drawn from the information available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT05604794 · results posted 12 May 2023

    According to the results reported on ClinicalTrials.gov, this trial enrolled 1,806 participants (referred to as "Clients") and set out to measure changes in self-reported symptoms of depression, anxiety, and post-traumatic stress. The trial used three standard questionnaires to do this: the PHQ-9 (which measures depression on a 0–27 scale), the GAD-7 (which measures anxiety on a 0–21 scale), and the PCL-6 (which measures post-traumatic stress on a 6–30 scale). On all three scales, a higher number means worse symptoms. It is worth noting that while 1,806 people started the trial, only 94 were recorded as having completed it, and the data was not reported on why the remaining 1,712 did not complete it. The reported data shows changes in scores from the start of the trial to later time points — a negative number means scores went down (i.e., reported symptoms decreased) over that period. For the primary outcomes, the PHQ-9 depression score changed by −3.23 points, the GAD-7 anxiety score changed by −4.80 points, and the PCL-6 post-traumatic stress score changed by −4.24 points. The secondary outcome measures reported additional score changes: the PHQ-9 was recorded at −3.23 and −4.74 points at what appear to be different time points, and the GAD-7 showed a change of −2.65 points. The reported data does not include the starting scores for each group, so the full context of these changes cannot be determined from the submitted results alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT04501445 · results posted 27 April 2023

    According to the results reported on ClinicalTrials.gov, this trial involved 90 participants who had been discharged from an Intensive Care Unit (ICU), or were family members/carers acting on a patient's behalf (sometimes called "surrogates"). All 90 people who started the study completed it. The trial was measuring levels of post-traumatic stress (a type of psychological distress that can follow a frightening experience), anxiety, depression, and how satisfied surrogates were with the care their loved one received in the ICU. The reported data shows that, at the initial survey point, participants scored an average of 27.9 out of 88 on a post-traumatic stress questionnaire (where higher numbers mean more distress), and an average of 12.8 out of 21 on a combined anxiety and depression questionnaire (where higher numbers mean greater symptom burden). For surrogate satisfaction with ICU care, the average score was 16.8 out of a possible 14–56 range, where lower scores indicate better satisfaction. The reported data also shows scores measured before and after a group intervention: the post-traumatic stress score was reported as 36.9 before the intervention and 24.1 afterwards, while the anxiety and depression score was reported as 15.9 at the later time point. The data does not fully clarify which participants were included in each of these before-and-after measurements, so those figures should be interpreted with care. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02933606 · results posted 27 February 2023

    According to the results reported on ClinicalTrials.gov, this trial tested three different doses of an investigational medicine called BNC210 — 150 mg, 300 mg, and 600 mg taken twice daily — against a placebo (an inactive tablet also taken twice daily) in people with post-traumatic stress disorder (PTSD). A total of 193 people were enrolled across the four groups, with roughly 48–49 starting in each group. Not everyone finished the trial — by the end, between 30 and 39 participants in each group had completed it. The main thing the trial measured was PTSD symptom severity as rated by a clinician using a standardised interview tool scored from 0 to 80, where a higher number means more severe symptoms. The reported data shows that at the end of the study, the average scores for the three BNC210 groups were 15.26 (600 mg), 16.62 (300 mg), and 19.76 (150 mg), compared with 14.57 for the placebo group. The trial also measured several other things: participants' own ratings of their PTSD symptoms (on a similar 0–80 scale) came in at 25.02, 20.99, and 29.97 for the three BNC210 doses respectively, versus 24.65 for placebo. Depression severity scores (0–60 scale) were 9.48, 10.25, and 12.16 for BNC210 groups versus 8.94 for placebo, and anxiety severity scores (0–56 scale) were 9.03, 9.94, and 10.55 versus 7.94 for placebo. Clinicians also counted how many participants showed improvement overall, but the reported data does not include enough detail to describe those numbers fully beyond what was submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02704754 · results posted 15 February 2023

    According to the results reported on ClinicalTrials.gov, this trial looked at a sleep medication called suvorexant in people with insomnia linked to post-traumatic stress disorder (PTSD). A total of 41 people took part — 21 in the suvorexant group and 20 in a placebo (dummy pill) group. Of those, 18 in the suvorexant group and 19 in the placebo group completed the trial. The trial measured changes in sleep difficulty, PTSD symptom severity, and an objective measure of wakefulness during the night recorded in a sleep lab. The reported data shows that for the main outcome — a standard questionnaire that scores insomnia severity from 0 (no insomnia) to 28 (severe insomnia) — the suvorexant group showed an average change of 6.8 points from their starting score, while the placebo group showed an average change of 8.6 points. For one of the secondary outcomes, a clinician-rated PTSD symptom scale (scored 0–80, with higher meaning more severe), the reported average change was 4.2 points in the suvorexant group and 3.8 points in the placebo group. For the other secondary outcome — the number of minutes participants spent awake after first falling asleep, measured in a sleep lab — the suvorexant group recorded an average of 21.0 minutes and the placebo group recorded 22.3 minutes. It is worth noting that these figures represent changes or values at a point in time, but the direction of those changes (i.e., whether scores went up or down from baseline) was not specified in the data as reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT04236284 · results posted 3 February 2023

    According to the results reported on ClinicalTrials.gov, this trial (NCT04236284) enrolled 21 adults who received a combination of home-based brain stimulation (called tDCS, where a mild electrical current is applied to the scalp at home) alongside a structured talking therapy called Prolonged Exposure Therapy. The trial was not designed to test whether the treatment worked — instead, it was a feasibility study, meaning its main goal was to find out whether it was practical to run this kind of trial: could researchers recruit enough people, collect biological samples (saliva), keep participants engaged, and gather complete data? The reported data shows that 21 people enrolled and 16 completed at least 8 sessions of the brain stimulation component, while 14 finished the full study. On the question of data collection, the reported figure for missing data was 0%, meaning no data gaps were recorded across participants who completed assessments. Participant satisfaction was measured using a standard questionnaire (the Charleston Psychiatric Outpatient Satisfaction Scale), which runs from 13 to 65 — a higher score meaning greater satisfaction. The reported average score was 42.48 out of 65. For two of the primary outcomes — the proportion of saliva samples successfully collected and the proportion of those samples that remained usable — no figures were reported in the submitted data. The reported data shows this was a small, single-group study with no comparison group, so all figures reflect only the people who received the combined treatment. No comparison was made against a placebo or alternative treatment, and the study was not set up to draw conclusions about whether the treatment itself produced any particular effect on participants' health. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01339689 · results posted 29 December 2022

    According to the results reported on ClinicalTrials.gov, this trial enrolled 112 participants in total — 59 received ganaxolone and 53 received a placebo (a dummy treatment with no active ingredient). The trial was measuring changes in PTSD (post-traumatic stress disorder) symptoms over six weeks, using a structured interview tool called the CAPS scale, which runs from 0 (no symptoms) to 136 (the most severe symptoms). Lower scores over time would indicate fewer reported symptoms. By the end of the trial, 42 of the 59 people in the ganaxolone group and 44 of the 53 in the placebo group had completed the study. The reported data shows that at the start of the trial, average CAPS scores were similar in both groups — around 65.8 for the placebo group and 62.7 for the ganaxolone group. By week 6, the placebo group's average score had dropped to around 60.6, while the ganaxolone group's average score had dropped to around 54.1. The reported data also shows scores across three symptom sub-categories (re-experiencing, avoidance, and hyperarousal — meaning intrusive memories, steering clear of reminders, and being on edge) followed a broadly similar pattern of reduction in both groups over the six weeks. For the investigator-rated global impression scale, at week 6 the reported data shows 12 out of 27 participants in the ganaxolone group were classed as "responders" (much or very much improved), compared with 12 out of 32 in the placebo group; similar figures were seen on the participant-rated version of that scale. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03703258 · results posted 2 December 2022

    According to the results reported on ClinicalTrials.gov, this trial (NCT03703258) involved 41 people in total — 20 in an intervention group and 21 in an assessment-only control group. All 41 participants completed the study with no drop-outs. The trial was measuring two main things: the severity of problem drinking (using a questionnaire called the RAPI-S, scored 0–64, where higher means more problems) and the severity of post-traumatic stress symptoms (using a questionnaire called the PCL-5, scored 0–80, where higher means more severe symptoms). Both were tracked at the start of the study, at three weeks, and at three months. The reported data shows that, for problem drinking, the intervention group started with an average score of 12.40, which dropped to 10.16 at three weeks and 5.75 at three months. The control group started at 11.00, dropping to 7.62 at three weeks and 5.55 at three months. For post-traumatic stress symptoms, the intervention group began at 46.60, fell to 36.53 at three weeks, and reached 22.10 at three months. The control group started at 39.81, was 35.62 at three weeks, and 25.30 at three months. The reported data also shows scores on two secondary measures — anxiety (scored 0–21) and coping self-efficacy, meaning a person's sense of their own ability to recover (scored 1–7). Anxiety scores in both groups were similar across all time points. Coping self-efficacy scores rose in both groups over the course of the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03812146 · results posted 16 November 2022

    According to the results reported on ClinicalTrials.gov, this trial (NCT03812146) involved 63 people in total — 33 in a group called PC-TIME and 30 in a group called PC-TAU. The trial was measuring symptoms of post-traumatic stress disorder (PTSD) and alcohol use in participants across both groups. Of those who started, 26 people in the PC-TIME group and 29 in the PC-TAU group completed the study. The reported data shows three primary things being measured at the end of the trial. First, PTSD symptom severity was assessed by a clinician using a structured interview scored from 0 to 80 (where higher means more severe): the PC-TIME group scored 28.46 on average, while the PC-TAU group scored 33.45. Second, PTSD symptoms were also rated by participants themselves on a self-report scale of 0 to 84 (again, higher means more severe): the PC-TIME group averaged 34.17 and the PC-TAU group averaged 43.40. Third, average number of drinks consumed per drinking day was recorded using a calendar-based tracking tool: the PC-TIME group reported an average of 2.34 drinks per day, compared to 3.72 in the PC-TAU group. These are the numbers as submitted — the trial did not report what the scores were at the *start* of the study in this section, so it is not possible from this data alone to describe how much change occurred over time. For a secondary outcome, the reported data shows the number of mental health or substance use appointments attended in the 20 weeks following enrolment: the PC-TIME group attended an average of 5.61 visits and the PC-TAU group attended an average of 5.73 visits. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02754557 · results posted 17 October 2022

    According to the results reported on ClinicalTrials.gov, this trial involved 65 people in total — 27 in a group practising breath-focused meditation on its own, and 38 in a group practising breath-focused meditation combined with physiological feedback (real-time information about the body's signals, such as heart rate). All 65 participants completed the four-week treatment period. The trial was measuring changes in four main areas: symptoms of dissociation (feeling detached from oneself or one's surroundings), symptoms of post-traumatic stress (PTSD), mindfulness skills, and awareness of body sensations. Measurements were taken at the start of the study, at four weeks (end of treatment), and again at eight weeks (one month after treatment ended). The reported data shows the following across both groups. On the dissociation scale (scores from 30 to 150, where higher means more symptoms), the breath-focused meditation group started at around 53 and reported scores of around 47 at four weeks and 44 at eight weeks; the combined group started at around 62 and reported scores of around 51 at four weeks and 48 at eight weeks. On the PTSD symptom scale (scores from 0 to 54, where higher means more symptoms), the breath-focused meditation group started at around 27 and reported scores of around 20 at four weeks and 18 at eight weeks; the combined group started at around 29 and reported scores of around 21 at four weeks and 19 at eight weeks. On the mindfulness scale (scores from 39 to 195, where higher means more mindfulness), both groups started at around 118–122 and reported scores in the range of 125–127 at both later timepoints. On the body-awareness scale (scores from 0 to 160, where higher means greater awareness), the breath-focused meditation group started at around 98 and reported scores rising to around 107 at four weeks and 111 at eight weeks; the combined group started at around 86 and reported scores rising to around 107 at four weeks and 105 at eight weeks. Two additional planned measures — a clinician-administered PTSD interview and a psychiatric diagnostic interview — were listed in the trial but no numerical results were reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02667119 · results posted 22 September 2022

    According to the results reported on ClinicalTrials.gov, this trial enrolled 27 people in total — 14 in a group that received a combination of two treatments called Prolonged Exposure and Contingency Management, and 13 in a Standard Care group. The trial was measuring two main things: changes in the severity of post-traumatic stress disorder (PTSD) symptoms, and how long participants went without using illicit drugs during a 10-week treatment period. It also looked at secondary outcomes including depression symptoms and quality of life. The reported data shows that, on a PTSD symptom scale running from 1 (least severe) to 5 (most severe), the combination-treatment group scored 1.92 at one measurement point and 1.64 at another, while the Standard Care group scored 2.61 and 2.29 at the same points — with lower numbers representing fewer reported symptoms on this scale. For drug abstinence, the reported data shows the combination-treatment group had a longest continuous stretch without illicit drugs of about 4.3 weeks on average, compared with about 1.8 weeks for the Standard Care group, out of the 10-week treatment window. On depression symptoms (scale 0–60, higher meaning more severe), the combination-treatment group recorded scores of 17.75 and 14.64 at two time points, while the Standard Care group recorded 23.33 and 21.69. For quality of life (scale −6 to +6, higher meaning better), the reported data shows scores of 1.66 for the combination-treatment group and 1.36 for the Standard Care group. It is worth noting that this was a small trial — fewer than 30 participants in total — and three people in the combination-treatment group did not complete the study, while all 13 in the Standard Care group did. These numbers should be kept in mind when reading any figures above. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03008005 · results posted 8 September 2022

    According to the results reported on ClinicalTrials.gov, this trial enrolled 46 people across three groups: 14 received a placebo (dummy pill), 17 received a 5 mg dose of dronabinol (a capsule form of a cannabis-derived compound), and 15 received a 10 mg dose of dronabinol. Most participants completed the study — 12 in the placebo group, 16 in the 5 mg group, and all 15 in the 10 mg group. The trial was measuring how the brain responds during a fear-learning task, looking at activity in specific brain regions and how participants anticipated an unpleasant sound (a noise burst) based on visual cues shown on a screen. The reported data shows brain activity was measured using a type of brain scan (fMRI), which tracks blood flow changes as a rough indicator of brain region activity. The numbers reported are expressed in arbitrary units (meaning they are relative measurements rather than standard physical units). For example, in one brain region measurement, the placebo group recorded approximately 0.04, the 5 mg group approximately 0.09, and the 10 mg group approximately 0.15. Other brain region measurements showed a mix of small positive and negative values across all three groups. For the expectancy ratings — where participants indicated whether they expected the noise burst to occur — the reported data shows, for example, that early in the task, 3 placebo participants, 5 in the 5 mg group, and 4 in the 10 mg group answered "yes." The data was not reported in a way that allows a straightforward plain comparison of overall group differences without further analysis. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02377089 · results posted 8 June 2022

    According to the results reported on ClinicalTrials.gov, this trial enrolled 60 people in total — 31 in the "sham" group (a comparison group receiving an inactive version of the treatment) and 29 in the "active" treatment group. By the end of the study, 22 people in the sham group and 24 in the active group completed the trial. The trial was measuring changes in PTSD (post-traumatic stress disorder) symptom scores and depression symptom scores over eight weeks, using two standard questionnaires completed at the start and end of the study period. The reported data shows that for the main outcome — a PTSD symptom questionnaire scored from 0 to 80 (where higher numbers mean more severe symptoms) — both groups started with very similar average scores of around 50–51 out of 80. By week 8, the reported average score had fallen to approximately 28.3 in the sham group and 28.6 in the active group. For the secondary outcome — a depression questionnaire scored from 0 to 63 (again, higher meaning more severe) — both groups also started at similar averages of around 28.3. By week 8, the sham group's average score had dropped to approximately 15.4 and the active group's to approximately 15.8. The reported data shows that both groups recorded notably lower scores on both questionnaires by the end of the eight weeks, though the numbers between the two groups were very close at both time points. It is worth noting that the data as submitted does not include statistical analysis figures explaining how to interpret these differences. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02655692 · results posted 2 June 2022

    According to the results reported on ClinicalTrials.gov, this trial (NCT02655692) enrolled 163 people with post-traumatic stress disorder (PTSD) across three groups: 55 received a placebo (an inactive substance), 55 received a low dose of ketamine, and 53 received a high dose of ketamine. The number who completed the trial was 36, 41, and 40 in each group respectively. The trial was measuring changes in PTSD symptom severity over time using a standard questionnaire called the PCL-5, where participants rate 20 symptoms on a scale from 0 ("not at all") to 4 ("extremely"), giving a total possible score of 0 to 80 — with higher scores meaning more severe symptoms. The reported data shows that all three groups started with similar PCL-5 scores at the beginning of the trial: approximately 48.6 for the placebo group, 46.6 for the low-dose ketamine group, and 47.9 for the high-dose ketamine group. Across six reported time points during the trial, the scores in all three groups generally trended downward (meaning reported symptom severity decreased over time). By the final reported time point, the placebo group's average score was approximately 30.8, the low-dose ketamine group's was approximately 26.4, and the high-dose ketamine group's was approximately 27.9. No secondary outcome measure data was included in the submitted results. The reported data shows changes in scores across all groups, but this summary does not draw any conclusions about what caused those changes or what they mean clinically. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03969589 · results posted 22 April 2022

    According to the results reported on ClinicalTrials.gov, this trial involved 40 people in total, split evenly into two groups of 20. One group took part in a Reproductive Life Planning–Mental Health Intervention, while the other group received written materials about reproductive life planning. The trial was measuring three things: how strongly participants intended to take steps toward their reproductive life goals, how confident they felt in making reproductive health decisions, and how favourably they viewed the idea of reproductive life planning. Seventeen people in each group completed the study, with three in each group not finishing. The reported data shows the following scores (higher numbers mean stronger intentions, confidence, or more positive attitudes in each case). For intentions to act on reproductive life goals (measured on a scale of 1 to 5): the intervention group started at 3.6 and ended at 3.3, while the written-materials group started at 2.7 and ended at 3.0. For confidence in making reproductive health decisions (scale of 0 to 44): the intervention group went from 35.7 to 40.7, and the written-materials group went from 33.9 to 38.7. For attitudes toward reproductive life planning (scale of 7 to 49): the intervention group moved from 38.1 to 38.9, while the written-materials group moved from 42.2 to 39.4. The reported data does not include information on whether these differences between groups were considered statistically meaningful (i.e., unlikely to be due to chance). It is worth noting that this was a small study with only 17 completers per group, so the numbers represent a very limited snapshot. No safety or broader health outcomes were reported in the structured results data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03711266 · results posted 18 February 2022

    According to the results reported on ClinicalTrials.gov, this trial (NCT03711266) enrolled 30 people in a single group called "PE-PC," which appears to refer to a type of therapy programme for post-traumatic stress disorder (PTSD). Of those 30 people who started, 20 completed the trial and 10 did not. The trial was measuring changes in PTSD symptoms as its main focus, and also tracked changes in depression symptoms, personal recovery goals, and unhelpful thought patterns related to trauma — all measured by questionnaire scores taken at the start of the trial and again at four months. The reported data shows the following changes in scores between the start of the trial and the four-month point (a higher change number means scores moved more from where they started). For the main outcome — PTSD symptoms, measured on a scale of 0 to 80 — the reported average change in score was 31.4 points. For depression symptoms, measured on a scale of 0 to 27, the reported average change was 8.5 points. For personal recovery goals, measured on a scale of 20 to 100 (where higher scores mean stronger sense of recovery), the reported average change was 9.57 points. For unhelpful thought patterns related to trauma, measured on a scale of 3 to 21 (where higher scores mean more unhelpful thoughts), the reported average change was 2.65 points. These figures represent averages across the participants who provided data; no breakdown was reported for individual participants. It is worth noting that with only one group in the trial — meaning there was no separate comparison or control group reported in this data — the figures describe change over time within that single group only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03996876 · results posted 7 December 2021

    According to the results reported on ClinicalTrials.gov, this trial involved 28 people in total — 14 in a group that received "Threat Attention Bias Modification" (ABM) training, and 14 in a group that received neutral attention training. Both groups used a mobile app called REPS (Resolving Psychological Stress). The trial was measuring changes in PTSD symptoms over 15 days, as well as differences in heart rate variability (a measure of how the heart responds to stress) during a computerised task involving the possibility of a mild electric shock. By the end of the study, 12 people in the threat training group and 10 in the neutral training group had completed the trial. The reported data shows that PTSD symptoms were measured using a 20-item questionnaire called the PCL-5, where scores range from 0 to 80 and a score of 33 or above is considered clinically significant. At the start of the study, the threat training group had an average score of 33.2 and the neutral training group had an average score of 36.6. After 15 days, the reported averages had shifted to 31.2 for the threat training group and 28.2 for the neutral training group. For the heart rate variability measure, no numerical results were reported in the data submitted to ClinicalTrials.gov. Regarding the app itself, participants in both groups were asked to rate it across five areas — ease of use, convenience, enjoyment, comfort, and overall satisfaction — on a scale of 1 to 5. The reported data shows scores were broadly similar between the two groups, ranging roughly from 3.2 to 4.6 across the different categories, suggesting participants found the app reasonably easy to use and comfortable overall. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01458327 · results posted 3 November 2021

    According to the results reported on ClinicalTrials.gov, this trial enrolled 3 participants, all of whom completed the study. There was only one group: people receiving therapy sessions that also included MDMA (commonly known as ecstasy). The trial was measuring changes in PTSD symptom severity over time using a structured interview tool called the CAPS-IV (Clinician-Administered PTSD Scale). This tool produces a score between 0 and 136, where a higher number means more severe PTSD symptoms. The reported data shows that, on average, participants started the trial with a CAPS-IV score of 93.3 out of 136. At the two-month follow-up point, the average score was reported as 31.3 — a reported change of minus 62 points from the starting score. At a longer-term follow-up of 12 months, the average score was reported as 52.7 — a reported change of minus 40.7 points from the starting score. These numbers simply describe what was measured and recorded at each time point; because the trial involved only 3 people and had no comparison group, the reported figures should be understood in that very limited context. It is worth noting that this was an extremely small trial with just 3 participants and no control or comparison group, which means the data as reported on ClinicalTrials.gov reflects only a very early, exploratory stage of research. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00090064 · results posted 25 October 2021

    According to the results reported on ClinicalTrials.gov, this trial involved 23 people in total — 15 in the MDMA-assisted therapy group and 8 in the placebo-with-therapy group. The trial was measuring changes in PTSD symptom severity over time, comparing people who received MDMA alongside talking therapy to those who received an inactive placebo alongside talking therapy. Thirteen of the 15 people in the MDMA group completed the trial, while all 8 in the placebo group completed it. The reported data shows results from two rating scales measured from the start of the trial to a two-month follow-up. The first was a clinician-administered interview called the CAPS-IV, which scores PTSD symptoms from 0 to 136 (higher scores mean more severe symptoms). The MDMA-assisted therapy group showed an average decrease of 55.2 points on this scale, while the placebo group showed an average decrease of 20.5 points. The second measure was a self-reported questionnaire called the IES-R, which scores personal distress related to a stressful event from 0 to 88. The reported data shows the MDMA-assisted therapy group had an average decrease of 29.7 points, compared to an average decrease of 12.9 points in the placebo group. These figures describe the average changes seen across each group during this particular trial — they do not tell us what any individual person experienced. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02268084 · results posted 1 October 2021

    According to the results reported on ClinicalTrials.gov, this trial enrolled 96 participants in total — 49 in the active treatment group and 47 in a sham (inactive/comparison) group. By the end of the study, 40 people in each group had completed it. The trial was measuring changes in symptoms of post-traumatic stress disorder (PTSD), sleep disturbance, and depression using three different questionnaire-based rating scales. The study had two phases: a "double-blind" phase (where neither participants nor researchers knew who was receiving active or sham treatment) and an "open-label" phase (where the treatment being given was known). The reported data shows the following changes in scores across all three scales. For PTSD symptoms (scored 17–85, where higher means more symptomatic), both groups started at similar levels (around 65–66). By the end of the double-blind phase, the active group's average score had fallen by about 22 points, while the sham group's fell by about 15 points. By the end of the open-label phase, the reported drops were around 33 points for the active group and 31 points for the sham group. For sleep disturbance related to PTSD (scored 0–21, higher meaning worse), the active group's score dropped by about 5 points in the double-blind phase and about 7 points by the open-label phase, compared to drops of about 2 and 5 points respectively in the sham group. For depression symptoms (scored 0–52, higher meaning more severe), the active group's score dropped by about 11 points in the double-blind phase and about 17 points by the open-label phase, compared to drops of about 8 and 15 points respectively in the sham group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00402298 · results posted 20 September 2021

    According to the results reported on ClinicalTrials.gov, this trial looked at MDMA-assisted therapy for post-traumatic stress disorder (PTSD). A total of 5 people took part — 3 in the full-dose group (125 mg MDMA) and 2 in the low-dose group (25 mg MDMA). Four of the five participants completed the study; one person in the full-dose group did not finish. The trial was measuring changes in PTSD symptom severity using a structured interview tool called the CAPS-IV, which produces a score between 0 and 136, where higher numbers mean more severe symptoms. A negative change in score means the score went down from where it started. The reported data shows the following changes in CAPS-IV scores from the starting point: at the 2-month follow-up, the full-dose group's average score changed by −0.5 points, while the low-dose group's average score changed by −7 points. At the 6-month follow-up, the full-dose group again showed a change of −0.5 points, while the low-dose group's average score had increased by 6 points (meaning it was higher than at the start). At the 12-month follow-up, a score change of −7.5 points was reported for the full-dose group; the 12-month result for the low-dose group was not reported in the data submitted. It is important to note that with only 5 participants in total, this was an extremely small study, and the reported numbers on their own cannot be used to draw broad conclusions. The reported data shows only what was measured in this very small group of individuals at specific points in time. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02500719 · results posted 20 August 2021

    According to the results reported on ClinicalTrials.gov, this trial involved two groups of adults: 14 healthy participants and 16 participants with PTSD (post-traumatic stress disorder). Not everyone finished the study — 11 of the 14 healthy participants and 9 of the 16 PTSD participants completed it. The trial was looking at whether people could voluntarily turn up or turn down their emotional reactions, and whether seeing real-time brain scan feedback on a screen made any difference to that ability. Brain activity was measured using a type of MRI scanning, and a computer program analysed the scans to produce scores showing the direction and strength of each person's emotional response. The reported data shows the results as numerical scores, where a positive number suggests the brain activity was moving in the direction of increased emotional arousal, and a negative number suggests it was moving in the direction of decreased emotional arousal. For the healthy participants group, all four reported scores were negative (ranging from around −0.02 to −0.32), meaning their brain activity tended toward the "dialling down" direction across the different conditions measured. For the PTSD participants group, the reported scores were more mixed — two were positive (approximately +0.47 and +0.52) and two were negative or near zero (approximately +0.008 and −0.07). The data does not include details about which specific score corresponds to which condition (for example, with or without feedback), so a full breakdown cannot be described here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00875342 · results posted 16 August 2021

    According to the results reported on ClinicalTrials.gov, this trial looked at whether a medicine called D-cycloserine had any effect on symptoms of Post-Traumatic Stress Disorder (PTSD) compared to a placebo (a dummy pill with no active ingredient). A total of 41 people took part — 20 in the D-cycloserine group and 21 in the placebo group. By the end of the study, 16 people in each group had completed the trial, with 4 and 5 people respectively not finishing. The reported data shows that PTSD symptoms were measured using a tool called the Clinician Administered PTSD Scale, or CAPS. This is a standardised questionnaire where scores range from 0 to 136, with higher numbers meaning more severe PTSD symptoms. At the end of the trial, the D-cycloserine group had an average score of 32.31, while the placebo group had an average score of 26.93. No other outcome measures were included in the data submitted to ClinicalTrials.gov, so further details about how these scores changed over time or any other measurements were not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01958593 · results posted 2 August 2021

    According to the results reported on ClinicalTrials.gov, this trial looked at MDMA-assisted therapy compared with a placebo (inactive substance) combined with therapy, in people with post-traumatic stress disorder (PTSD). In the first stage of the trial, 2 participants received placebo with therapy and 4 received MDMA-assisted therapy. In a second open-label stage (where everyone knew what they were receiving), the 2 participants who had originally received placebo crossed over to receive MDMA-assisted therapy, bringing the total number of people who took part across both stages to 6. The trial was measuring changes in PTSD symptom scores, as well as scores related to depression, sleep quality, general functioning, and other wellbeing measures. The reported data shows that the primary measure — a clinician-conducted interview called the CAPS-IV, which scores PTSD symptom severity from 0 to 136 (higher meaning more severe) — showed an average score reduction of 21.5 points in the placebo-with-therapy group and 17.3 points in the MDMA-assisted therapy group from the start of the trial to the end point. For a self-reported PTSD symptom scale (the PDS, scored 0–51), the reported average change was a reduction of 1.0 points in the placebo group and 5.3 points in the MDMA group. For a depression measure (BDI-II, scored 0–63), the placebo group showed an average reduction of 4.0 points, while the MDMA group showed an average increase of 2.0 points. A general functioning scale (GAF, where higher scores mean better functioning) showed small average increases of 5.0 and 5.3 points respectively in both groups. For sleep quality (PSQI, where lower scores mean better sleep), the placebo group's average score went up by 1.0 point and the MDMA group's went down by 3.5 points. Finally, a measure of dissociation (DES-II, scored 0–100) showed an average increase of 8.4 points in the placebo group and an average decrease of 4.6 points in the MDMA group. It is worth noting that this was a very small trial with only 6 participants in total, and these reported numbers represent averages across those very few people. The reported data shows what was measured in this specific group and cannot be applied broadly. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00391430 · results posted 21 July 2021

    According to the results reported on ClinicalTrials.gov, this trial looked at three groups of people: those receiving the medication sertraline (8 participants), those receiving cognitive behavioural therapy — a type of talking therapy often called CBT (31 participants), and a control group (0 participants). In total, 39 people started the study. Of those, 24 completed it — 5 in the sertraline group and 19 in the CBT group. The trial was measuring how the brain and body respond to fearful images and stressful situations, using a brain scanning technique called an fMRI (a scan that tracks brain activity) and saliva samples to measure cortisol, a hormone the body releases under stress. The reported data shows that numerical results were not submitted for any of the outcome measures — neither the two primary measures (cortisol levels and fear response during the brain scan) nor the four secondary measures (which assessed trauma history, the severity of PTSD symptoms, anxiety and mood disorder diagnoses, and the frequency and severity of panic attacks). Because no figures were provided in the structured results data, it is not possible to describe what the measurements showed for any of the three groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01329341 · results posted 9 July 2021

    According to the results reported on ClinicalTrials.gov, this trial involved 60 participants, all assigned to a single group referred to as "Arm 1" (Service Dog). The trial was set up to measure mental health outcomes, specifically focusing on PTSD (post-traumatic stress disorder) symptoms using a tool called the PCL-S, which is a standard questionnaire used to assess the severity of PTSD-related symptoms. Of the 60 people who started the trial, 16 completed it, while 44 did not complete it. The reported data shows that, unfortunately, no numerical measurement results were included in the data submitted to ClinicalTrials.gov for the primary outcome measure — that is, the actual PCL-S symptom scores were not reported. This means it is not possible to describe what change, if any, was observed in participants' PTSD symptoms over the course of the trial. No secondary outcome measures were reported either. Because such a large number of participants (44 out of 60) did not complete the trial, and because the key measurement results were not reported in the submitted data, the findings from this study are very limited based on what is publicly available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02655354 · results posted 2 July 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT02655354) enrolled 635 people who had experienced an injury — 265 in the Intervention group and 370 in the Usual Care group. The study followed participants over the course of a year after their injury. It was measuring changes in four areas: symptoms linked to post-traumatic stress (PTSD), depression, alcohol use, and physical function. Researchers used standard questionnaires to track how scores in each of these areas changed from the start of the study to later points in time. The reported data shows that for PTSD symptoms (measured on a scale of 17–85, where higher means worse), both groups' scores fell over the year. The Intervention group's scores dropped by roughly 1.7, then 4.0, then 5.5 points at successive measurement points, while the Usual Care group's scores dropped by roughly 0.1, 1.4, and 4.3 points. For depression (scale 0–27, higher is worse), both groups showed small reductions across the year — the Intervention group by around 0.8, 1.2, and 1.8 points, and the Usual Care group by around 0.5, 0.9, and 2.2 points. For alcohol use (scale 0–40, higher is worse), both groups showed similar small reductions across all time points, ranging from roughly 1.5 to 2.0 points in each group. For physical function (scale 0–100, where higher is *better*), both groups' scores declined from baseline across the year, with the Intervention group dropping by roughly 16.8, 14.2, and 13.2 points, and the Usual Care group by roughly 15.9, 13.8, and 11.7 points. Regarding the secondary measures, the reported data shows that the number of participants indicating suicidal thoughts (a score of 1 or more on a single question) and the number reporting non-prescribed opioid use at least monthly were counted at each time point across both groups — these figures varied across measurement points, with the Usual Care group generally recording higher numbers of participants in both categories at most time points. It is worth noting that a notable number of participants did not complete the study — 77 in the Intervention group and 81 in the Usual Care group — which is common in long-running trials but means the final numbers are based on fewer people than originally enrolled. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01749215 · results posted 21 June 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT01749215) enrolled 151 people — 72 in the topiramate group and 79 in the placebo group. Of those, 47 and 53 respectively completed the study. The trial was looking at whether topiramate, a medication, had any measurable impact on heavy drinking days in people who also had post-traumatic stress disorder (PTSD). It also measured changes in PTSD symptom severity, impulsivity, risk-taking behaviour, and decision-making over 12 weeks. The reported data shows that, when it came to the main thing being measured — the change in the percentage of "heavy drinking days" — the topiramate group reported an average reduction of 36.2 percentage points, compared with a reduction of 25.1 percentage points in the placebo group. For PTSD symptom severity (scored on a scale from 17 to 85, where lower is better), both groups reported similar reductions: about 15.4 points in the topiramate group and 15.9 points in the placebo group. On a measure of impulsivity, the topiramate group's score decreased by 0.020 units while the placebo group's score increased by 0.058 units (where a decrease represents less impulsivity). For risk-taking behaviour, both groups showed increases in the number of pumps on the computer task used (where more pumps means more risk-taking) — 26.7 in the topiramate group and 13.4 in the placebo group. For decision-making, both groups showed small improvements, with the topiramate group improving by 2.03 points and the placebo group by 2.80 points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02911285 · results posted 19 May 2021

    According to the results reported on ClinicalTrials.gov, this trial looked at people with both alcohol use disorder and post-traumatic stress disorder (PTSD). A total of 90 people started the trial — 49 in the group that received a supplement called N-acetylcysteine (NAC) alongside talking therapy (Cognitive Behavioral Therapy, or CBT), and 41 in the group that received a placebo (a dummy pill) alongside the same talking therapy. By the end of the 8-week study, 40 people in the NAC+CBT group and 36 in the placebo+CBT group had completed it. The trial measured four things: how many days per week people were drinking alcohol, how strong their alcohol cravings were, and PTSD symptom severity using two different questionnaires. The reported data shows the following changes from the start of the trial to week 8. For drinking days per week, the NAC+CBT group reported a reduction of 2.65 days and the placebo+CBT group reported a reduction of 2.82 days (out of a possible 7 days). For alcohol cravings, scored on a scale of 0–56, the NAC+CBT group reported a reduction of 3.97 points compared to 2.92 points in the placebo+CBT group. For PTSD symptoms measured by a clinician (on a scale of 0–80), the NAC+CBT group reported a reduction of 6.93 points versus 5.53 points in the placebo+CBT group. Using a self-reported PTSD questionnaire (also 0–80), the NAC+CBT group reported a reduction of 12.97 points compared to 9.97 points in the placebo+CBT group. In all four measures, both groups reported reductions from their starting points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02992899 · results posted 19 May 2021

    According to the results reported on ClinicalTrials.gov, this trial looked at how a technique called vagal nerve stimulation — gentle electrical stimulation of a nerve in the ear or neck — affected certain chemicals in the blood during emotional stress testing. A total of 56 people took part: 27 in the vagal nerve stimulation group and 29 in a "sham" (fake stimulation) group, which acted as a comparison. Of those, 25 and 26 people respectively completed the study. Blood samples were taken before and after a stress test to measure levels of several substances, including an inflammation-related protein called Interleukin-6 (IL-6) and a number of chemicals linked to how the body processes the amino acid tryptophan. The reported data shows the following blood level readings (before stress test / after stress test). For IL-6, measured in pg/ml (picograms per millilitre, a very small unit of concentration): the vagal nerve stimulation group recorded 0.88 before and 1.77 after; the sham group recorded 0.84 before and 2.11 after. For tryptophan: vagal nerve stimulation group 50.59 then 54.42 micromoles per litre; sham group 55.80 then 57.79. For kynurenine: vagal nerve stimulation group 4.72 then 5.04 µM; sham group 7.19 then 7.06 µM. For kynurenic acid: vagal nerve stimulation group 35.71 then 38.81 pmol/100 microlitres; sham group 43.07 then 37.88. For anthranilic acid: vagal nerve stimulation group 8.32 then 7.49 nM; sham group 7.02 then 6.90 nM. The reported data for the substance 3-3 hydroxykynurenine was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01806168 · results posted 14 April 2021

    According to the results reported on ClinicalTrials.gov, this trial enrolled 31 people in total across three groups. Eleven were assigned to low-frequency (1 Hz) repetitive transcranial magnetic stimulation (rTMS — a non-invasive brain stimulation technique), ten to high-frequency (10 Hz) rTMS, and ten to a sham (inactive/dummy) version of the procedure. The trial was measuring PTSD symptom severity as its main focus, and also looked at symptoms of depression and anxiety as secondary measures. By the end of the study, 10, 9, and 7 participants had completed the trial in each group respectively. The reported data shows that the main outcome — PTSD symptom severity — was measured using a clinician-administered interview scored from 0 to 136, where higher numbers mean more severe symptoms. At the end of the study, the average scores reported were 59.80 for the low-frequency rTMS group, 74.00 for the high-frequency rTMS group, and 65.12 for the sham group. For the secondary measures, participants also filled in self-report questionnaires. On a self-rated PTSD checklist (scored 17–85), average scores were 48.10, 53.44, and 52.14 for the three groups respectively. On depression scales, the clinician-rated scores (out of 53) were 12.30, 11.22, and 14.44, while the self-rated depression scores (out of 27) were 12.66, 15.00, and 9.42. For anxiety, a 63-point self-report scale returned averages of 24.70, 22.77, and 28.14, and a shorter 7-item anxiety scale (out of 21) returned averages of 11.90, 8.50, and 11.75 across the three groups. It is worth noting that the reported data shows scores at a single time point and does not include before-and-after change figures or statistical comparisons between groups — those were not reported in the structured data submitted to ClinicalTrials.gov, so no conclusions about differences between groups can be drawn from the numbers above alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03533608 · results posted 5 March 2021

    According to the results reported on ClinicalTrials.gov, this trial (NCT03533608) involved a single group of 39 participants who received an approach called Prolonged Exposure (PE) therapy. Of those, 34 completed the study and 5 did not finish. The trial was measuring changes in two things over time: symptoms of PTSD (post-traumatic stress), using a questionnaire called the PCL-5, and symptoms of depression, using a questionnaire called the PHQ-9. Both questionnaires ask participants to rate how much certain experiences have bothered them, and their answers are added up to give a total score. Measurements were taken at the start of the study (baseline), at 6 weeks, and at 2 months. The reported data shows that, on average, participants' PCL-5 PTSD symptom scores dropped by 23.86 points from baseline to the 6-week mark, and by 19.51 points from baseline to the 2-month mark. To give that context, the PCL-5 scale runs from 0 to 80, and a score of 33 or above is used as a rough indicator of PTSD. For depression, the reported data shows average PHQ-9 scores dropped by 4.68 points from baseline to 6 weeks, and by 4.04 points from baseline to 2 months. The PHQ-9 scale runs from 0 to 27, where higher scores indicate more severe depressive symptoms. These figures represent the average change across the group — individual results would have varied. It is worth noting that this trial had only one group and no comparison group, so the reported numbers describe what was measured in these participants only. No data was reported for any control or comparison condition. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03225859 · results posted 8 February 2021

    According to the results reported on ClinicalTrials.gov, this trial involved 12 adults who took part in a self-management program, with 11 completing the study and 1 not finishing. The trial was measuring two main things: how believable and logical participants found the program's approach (using a credibility scale), and how satisfied they were with the program overall (using a satisfaction scale). It also tracked changes in several areas from the start to the end of the program, including participants' sense of control over their PTSD symptoms, their PTSD symptom levels, their depression symptom levels, and their overall sense of their own mental health. The reported data shows that on the credibility scale — which runs from 1 to 9, with higher numbers meaning the program's approach felt more believable — participants scored an average of 6.39. On the satisfaction scale, which runs from 8 to 32 with higher scores meaning greater satisfaction, the average score reported was 29.67. These were the two primary (main) outcomes the trial set out to measure. For the secondary (additional) outcomes, the reported data shows the following average changes from the beginning to the end of the program: participants' sense of personal control over their PTSD symptoms increased by 0.33 points (on a 1–5 scale where higher means more control); PTSD symptom scores decreased by 1.67 points (on a 0–80 scale where lower means fewer symptoms); depression symptom scores decreased by 0.14 points (on a 0–27 scale where lower means fewer symptoms); and scores on a measure of perceived mental health decreased by 1.0 point (on a 1–5 scale where lower scores indicate better perceived mental health). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03364192 · results posted 21 December 2020

    According to the results reported on ClinicalTrials.gov, this trial involved 28 participants, all of whom received a programme called Peer-delivered Whole Health Coaching. The trial was measuring whether participants made progress toward personal wellbeing goals they had set for themselves, and also looked at symptoms of PTSD (post-traumatic stress disorder), day-to-day social and life functioning, and how satisfied participants were with the coaching service. Of the 28 people who started, 12 completed the study and 16 did not complete it. The reported data shows that on the main measure — a personalised goal-progress scale scored from 0 to 10 (where higher means better progress) — participants' average scores were 2.33 at one point, rising to 4.15 and then 4.63 at later time points. For PTSD symptoms (scored 0–80, where lower is considered more positive), the reported scores across the four time points were 42.4, 53.5, 49.22, and 49.61. For everyday social and life functioning (scored 0–100, where lower is considered more positive), the reported scores across four time points were 38.74, 30.49, 28.24, and 28.59. On the satisfaction questionnaire (scored 8–32, where higher means greater satisfaction), the reported average score was 27.18 out of 32. It is worth noting that the data does not specify which scores correspond to which exact time points (for example, before, during, or after the programme), so the sequence cannot be confirmed from the information provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03702166 · results posted 16 December 2020

    According to the results reported on ClinicalTrials.gov, this trial (NCT03702166) involved 10 people who received a treatment called Cognitive Processing Therapy (CPT) — a type of talking therapy. The trial was measuring changes in PTSD symptoms, tinnitus (ringing in the ears), depression, and thoughts of suicide in this group. Of the 10 people who started, 8 completed the trial and 2 did not finish. The reported data shows the following score changes, from the start of the trial to the end. On the CAPS-5 — a clinician-led interview rating PTSD symptom severity out of 80 — scores went from 33.10 down to 16.13. On the PCL-5 — a self-reported PTSD symptom questionnaire also out of 80 — scores went from 42.7 down to 17.75. For tinnitus, the Tinnitus Functional Index (scored 0–100, where higher means tinnitus interferes more with daily life) went from 65.16 down to 41.95. The Tinnitus Acceptance Questionnaire (scored 0–72, where a *lower* score means greater acceptance) went from 35.10 up to 46.88, meaning reported acceptance of tinnitus appeared to decrease on this scale. For the secondary measures, depression symptoms (PHQ-9, out of 27) went from 14.10 to 7.38, and suicidal thoughts (DSI-SS, out of 16) also went from 14.10 to 7.38. It is worth noting this was a very small group of 10 people, and the trial did not include a comparison group, so these numbers reflect what was observed in this one group only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02853032 · results posted 3 November 2020

    According to the results reported on ClinicalTrials.gov, this trial enrolled 119 people — 60 in the active treatment group and 59 in a sham (inactive/pretend) treatment group. The trial was comparing a technique called repetitive transcranial magnetic stimulation (rTMS), which uses magnetic pulses directed at a specific area of the brain, against a sham version that mimicked the procedure without delivering real pulses. The study was measuring changes in the severity of PTSD symptoms and depression symptoms across both groups, using several standard questionnaires rated by participants or clinicians. The reported data shows that, for the main measure of PTSD symptom severity (a questionnaire called the PCL-5, scored from 0 to 80 where higher means more severe), the active rTMS group started with an average score of about 59.8 and ended at around 33.3, while the sham group started at about 60.5 and ended at around 39.1. A separate clinician-rated PTSD measure showed the active group going from roughly 45.1 down to 24.8, and the sham group from about 46.1 down to 31.0. For depression, one questionnaire (PHQ-9, scored 0–27) showed the active group moving from about 17.8 to 10.7, and the sham group from about 19.3 to 14.2. Another depression scale (MADRS, scored 0–60) showed the active group going from roughly 25.6 to 14.0, and the sham group from about 28.1 to 16.2. These are the numbers as submitted; the trial did not report whether differences between the groups were considered statistically meaningful (i.e., unlikely to be due to chance). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02742532 · results posted 19 October 2020

    According to the results reported on ClinicalTrials.gov, this trial involved 63 people — 31 in the oxytocin group and 32 in the placebo group. The trial was measuring changes in alcohol craving and stress levels, using a simple self-rating line (called a Visual Analog Scale, or VAS), where participants marked a point on a 100-millimetre line to show how they were feeling — with 0 meaning no craving or stress and 100 meaning the most possible. Most participants finished the trial: 28 out of 31 in the oxytocin group and 31 out of 32 in the placebo group. The reported data shows that for the main measurement — change in alcohol craving — the oxytocin group's average score changed by +0.076 points (a tiny increase) while the placebo group's average score changed by −0.928 points (a small decrease) on that 0–100 scale. For the secondary measurement — change in stress — the oxytocin group's average score changed by −0.755 points and the placebo group's average score changed by −1.268 points, both representing very small reductions on the same scale. In both cases, the changes reported were very small in absolute terms. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03251326 · results posted 12 October 2020

    According to the results reported on ClinicalTrials.gov, this trial (NCT03251326) enrolled four participants across four different treatment groups. Each group received a different combination of active or placebo (dummy) versions of three substances — nabiximols (a cannabis-based medicine), propranolol, and a cannabis preparation — given in sequence. The trial was measuring something called "cue reactivity," which refers to how strongly a person responds, mentally or emotionally, when exposed to reminders related to substance use. This was assessed using a task called the Emotional Stroop Task, a computer-based attention test. The reported data shows that the trial was terminated early due to a lack of feasibility — meaning it was not practical to continue. Of the four participants who started, only two completed the study, and two did not finish. Regarding the primary outcome (cue reactivity), no numerical results are available. According to the results reported on ClinicalTrials.gov, the research team was unable to provide any data because the staff responsible for collecting and managing the data had left the institution, and despite efforts to locate the records for the two participants who completed the study, the data could not be found. The reported data shows no outcome figures for any of the four groups, as the data is stated to be inaccessible. No secondary outcome results were reported either. Given the very small number of participants and the early termination of the trial, the submission to ClinicalTrials.gov does not contain any findings about the measures the study set out to examine. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02335125 · results posted 11 September 2020

    According to the results reported on ClinicalTrials.gov, this trial enrolled 40 people in total — 20 in an intervention group and 20 in a usual care (standard treatment) group. All 40 participants completed the study. The trial was measuring changes over one month in three main areas: symptoms associated with PTSD (post-traumatic stress disorder — a condition where distressing memories or feelings follow a traumatic event), alcohol use, and depression. It also looked at physical functioning, thoughts of self-harm, and drug use as secondary (additional) measures. The reported data shows that for PTSD symptoms, scores on the checklist (where higher numbers mean more symptoms) changed by an average of 1.30 points in the intervention group and 5.04 points in the usual care group from the start of the study to one month. For alcohol use (scored 0–40, higher meaning more harmful use), scores changed by −1.36 in the intervention group and −2.31 in the usual care group — both reductions from their starting points. For depression (scored 0–27, higher meaning more severe), scores changed by 1.27 in the intervention group and 0.28 in the usual care group. Regarding thoughts of self-harm, the reported data shows 3 people in the intervention group and 2 in the usual care group reported this at one point during the study, and 4 and 6 respectively at another point. For drug use, 12 intervention and 10 usual care participants reported use at one timepoint, and 15 and 13 at another. Physical functioning scores and some other figures appear in the data but the timepoints these correspond to were not clearly labelled in the submitted results, so a straightforward comparison cannot be described with confidence. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00265564 · results posted 7 September 2020

    According to the results reported on ClinicalTrials.gov, this trial involved 117 participants — 59 in a group receiving a programme called "Seeking Safety" and 58 receiving "Usual Care." Of those, 49 people in each group completed the study. The trial was measuring the severity of alcohol and drug use (using a tool called the Addiction Severity Index, or ASI) and symptoms of post-traumatic stress (PTSD) over time, across multiple follow-up points. The ASI scores run from 0 to 1, where a lower number means less severe substance use, and the PTSD symptom score runs from 0 to 88, where a lower number means fewer symptoms reported. The reported data shows that for alcohol use severity, both groups started at similar levels (Seeking Safety: 0.259, Usual Care: 0.225) and both showed lower scores at each follow-up point, finishing at 0.149 and 0.134 respectively. For drug use severity, both groups also started at similar levels (Seeking Safety: 0.089, Usual Care: 0.106) and both recorded lower scores over time, ending at 0.046 and 0.066 respectively. The reported data shows that for PTSD symptoms, both groups began with scores around 46–48 out of 88, and both recorded lower scores at each follow-up, finishing at 35.26 (Seeking Safety) and 34.07 (Usual Care). Across all three measures, the reported numbers for both groups moved in a similar direction over the course of the study. No information about whether any differences between the groups were considered statistically meaningful (that is, unlikely to be due to chance) was included in the submitted data on ClinicalTrials.gov, so that cannot be reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00760994 · results posted 10 August 2020

    According to the results reported on ClinicalTrials.gov, this trial involved 80 people in total across three groups. Twenty-nine participants were placed in a group using a approach called Experiential Acceptance (EA), 31 were in a group using Cognitive Restructuring (CR) — both of these being psychological techniques aimed at managing difficult thoughts and feelings — and 20 were in a control group (meaning they did not receive either technique). The trial was measuring two things over a five-week period: how much alcohol people reported drinking each day, and the severity of their post-traumatic stress disorder (PTSD) symptoms each day. Participants reported this information daily using an automated phone system. Not everyone finished the study — 25, 27, and 17 people completed it in the EA, CR, and control groups respectively. The reported data shows that, for average drinks per day, the EA group reported 3.6 drinks, the CR group reported 1.8 drinks, and the control group reported 3.1 drinks. For the PTSD symptom scores — measured on a scale from 0 (no symptoms) to 96 (most severe) — the reported data shows the EA group averaged 2.7, the CR group averaged 3.1, and the control group averaged 3.0. These numbers represent averages across the five-week follow-up period as reported by participants through the daily phone check-ins. It is worth noting that the reported data shows only the averaged figures for each group, and no further breakdown of the results was reported in this submission to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02723344 · results posted 28 July 2020

    According to the results reported on ClinicalTrials.gov, this trial (NCT02723344) enrolled 31 people in total — 15 in a placebo group and 16 in a group receiving a probiotic called *Lactobacillus reuteri* (L. Reuteri). All 15 people in the placebo group completed the trial, while 12 of the 16 in the L. Reuteri group completed it (4 did not finish). The trial was measuring changes in certain substances in the blood that are linked to inflammation, as well as gut permeability (how "leaky" the gut lining is) and self-reported stress levels during a structured stress task. The reported data shows that for the primary outcome — change in C-Reactive Protein (a marker of inflammation measured in blood) — the placebo group showed a small increase of 0.113 mg/L, while the L. Reuteri group showed a decrease of 0.625 mg/L. For a secondary measure called Tumour Necrosis Factor (another inflammation marker in blood), the placebo group showed a change of −0.62 pg/ml and the L. Reuteri group showed a change of −2.1 pg/ml. For other pre-specified measures, Interleukin 6 changed by +0.22 pg/ml in the placebo group and −0.07 pg/ml in the L. Reuteri group; Interleukin 10 changed by +0.15 pg/ml and −0.23 pg/ml respectively; and the gut permeability marker (IFABP) changed by −0.09 pg/ml in the placebo group and −0.04 pg/ml in the L. Reuteri group. The reported data also shows self-reported stress scores (on a 1–10 scale, where higher means more stress) measured at three points during a structured stress task. At the starting point, the placebo group scored 4.13 and the L. Reuteri group scored 5.38; after a speech task, scores were 5.29 and 6.25 respectively; and after a maths task, scores were 6.44 and 7.13 respectively. No further breakdown or explanatory context for these stress score differences was reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT03821259 · results posted 23 June 2020

    According to the results reported on ClinicalTrials.gov, this trial enrolled 88 older adults who had a history of mental health difficulties. All 88 participants completed the study — none dropped out. The trial was not testing a treatment; rather, it was a descriptive study designed to measure several characteristics of this group, including their lifetime exposure to traumatic events, how they manage emotions, symptoms associated with post-traumatic stress (PTSD), how strongly they felt connected to social groups such as family or community, and their level of socioeconomic disadvantage based on where they lived in Scotland. The reported data shows the following average scores across the 88 participants. On the Trauma History Questionnaire (scored 0–24, where higher means more traumatic experiences reported), the average total score was 5.93. On the Difficulties in Emotion Regulation Scale (scored 36–180, where higher means greater difficulty managing emotions), the average total score was 93.63, with individual area scores ranging from approximately 11.51 to 21.51 across the six areas measured. On the PTSD symptom checklist (scored 17–85, where higher means more severe symptoms), the average score was 42.14 — the reported data notes that a score of 37 or above has been suggested in research as a threshold worth noting in this age group. On the social group identification measure, participants identified with an average of 1.73 out of a possible 3 groups (such as family, community, or a chosen social group). On the socioeconomic deprivation measure (scored 1–5, where 1 is most deprived and 5 is least deprived), the average score was 3.31. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02576899 · results posted 10 April 2020

    According to the results reported on ClinicalTrials.gov, this trial looked at two smoking cessation programs for people with post-traumatic stress disorder (PTSD). One group received a program called ACT-PT (Acceptance and Commitment Therapy adapted for PTSD and smoking), and the other received an established stop-smoking program called Freedom From Smoking (FFS). A total of 36 people started the trial — 16 in the ACT-PT group and 20 in the FFS group. By the end, only 5 people in the ACT-PT group and 7 in the FFS group completed the study, meaning a large number of participants did not finish. The reported data shows that for the main measure of smoking — whether a person had not smoked in the past 7 days at the end of the program, confirmed by a breath test — 4 participants in the ACT-PT group met this measure, compared to 0 in the FFS group. On a questionnaire measuring PTSD symptom severity (scored from 0 to 80, where higher numbers mean more severe symptoms), the ACT-PT group averaged a score of 38.8 and the FFS group averaged 44.6. For mental health functioning (scored 0 to 100, where higher means better functioning), the ACT-PT group averaged 51.3 and the FFS group averaged 44.3. For quality of life (also scored 0 to 100, where higher means better quality of life), the ACT-PT group averaged 44.3 and the FFS group averaged 37.5. It is important to note that the numbers of people who completed this trial were very small, and these figures simply reflect what was measured and recorded. The reported data does not allow any broad conclusions to be drawn about either program. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02546570 · results posted 8 April 2020

    According to the results reported on ClinicalTrials.gov, this trial enrolled 11 adults in total — 9 who had been diagnosed with post-traumatic stress disorder (PTSD) and 2 who had experienced trauma but did not have PTSD. All 11 participants completed the trial, and none dropped out. The study used a "crossover" design, meaning each person received both a nasal spray containing oxytocin (a naturally occurring brain chemical) and a dummy (placebo) spray on separate occasions, so their brain responses could be compared under each condition. While participants received the spray, researchers used a brain scanning technique called fMRI (which measures blood flow changes in the brain as a way of tracking brain activity) to record how specific brain regions responded to gentle touch — stroking the forearm versus the palm of the hand. The reported data shows percentage changes in brain activity across six specific brain regions that are linked to processing emotions, social connection, and threat responses. In the PTSD group, the anterior insula region showed −12.6% activity with oxytocin and −1.6% with placebo (forearm condition), and −13.9% versus +3.9% (palm condition). The amygdala — a region associated with fear responses — showed −3.8% with oxytocin and −9.1% with placebo (forearm), and −4.2% versus +0.58% (palm) in the PTSD group. In the non-PTSD group, the amygdala showed +14.5% with oxytocin and −6.7% with placebo (forearm). Results across the other measured regions (accumbens, dACC, mOFC, and rACC) also varied between groups and between oxytocin and placebo conditions, with figures ranging from around −30% to +16% depending on the region and condition. It is important to note that this was a very small study with only 11 participants, and the reported data reflects brain activity measurements only — not clinical symptoms or treatment outcomes. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02234622 · results posted 17 March 2020

    According to the results reported on ClinicalTrials.gov, this trial compared two programs for people with PTSD (post-traumatic stress disorder): a Holistic Yoga Program and a Wellness Lifestyle Program. A total of 212 people started the trial — 108 in the yoga group and 104 in the wellness group. Of those, 65 in the yoga group and 68 in the wellness group completed the study, meaning a notable number of participants did not finish in both groups. The trial measured PTSD symptom severity using both a clinician-led interview and a self-reported questionnaire, as well as several other measures including sleep quality, anger, depression, and anxiety. The reported data shows that, at the end of the study, the yoga group scored an average of 25.8 on the clinician-administered PTSD interview (out of a possible 80, where higher means more severe symptoms), compared to 31.0 in the wellness group. On the self-reported PTSD questionnaire (also out of 80), the yoga group averaged 33 and the wellness group averaged 40.2. For sleep problems (scored 0–100, higher being worse), the yoga group averaged 45 and the wellness group 55. Depression scores (out of 63, higher being worse) were 17.4 for the yoga group and 18.7 for the wellness group. For anxiety (scored 20–80, higher being worse), the yoga group averaged 29.5 and the wellness group 27.6. Anger was measured on a standardised scale where 50 represents the average in the general population; both groups scored above that mark — 57.1 for the yoga group and 58.9 for the wellness group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01847469 · results posted 16 March 2020

    According to the results reported on ClinicalTrials.gov, this trial looked at a medication called zonisamide compared to a placebo (a dummy pill with no active ingredient) in people who had both post-traumatic stress disorder (PTSD) and problems with alcohol use. A total of 24 people started the trial — 18 in the zonisamide group and 6 in the placebo group. Half of each group (9 and 3 people respectively) completed the full 12 weeks. The trial measured three things over that period: the number of days participants drank alcohol, the number of "heavy drinking" days (defined as 5 or more drinks in a day for men, or 4 or more for women), and the severity of PTSD symptoms using a standard questionnaire called the CAPS scale (scored from 0 to 136, where higher numbers mean more severe symptoms). The reported data shows the following numbers at the end of the 12-week period. For drinking days, the zonisamide group reported an average of 7.44 days, compared with 17.33 days in the placebo group (with starting averages of around 47 and 51 days respectively, measured over the prior 90 days). For heavy drinking days, the zonisamide group reported an average of 5.50 days and the placebo group reported 4.16 days (starting averages were approximately 44 and 32 days respectively). For PTSD symptom scores, the zonisamide group averaged 30.83 and the placebo group averaged 23.80 at the end of treatment (starting averages were approximately 67 and 73 respectively). It is worth noting that only 12 of the 24 people who started the trial completed it, which means the numbers above are based on a very small group of participants. The reported data does not include any explanation of why half the participants did not finish. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01962714 · results posted 27 February 2020

    According to the results reported on ClinicalTrials.gov, this trial (NCT01962714) compared two approaches for people with PTSD: Loving-Kindness Meditation (LKM) and a form of Cognitive Processing Therapy called CPT-C (Cognitive Only). A total of 184 people started the trial — 91 in the LKM group and 93 in the CPT-C group. By the time the trial wrapped up, 61 people in the LKM group and 60 in the CPT-C group had completed it. The trial was measuring PTSD symptom severity and depression levels, and was specifically designed to look at whether LKM performed similarly to (that is, was "non-inferior" to) CPT-C — meaning it was testing whether LKM was not meaningfully worse, rather than whether it was better. The reported data shows two main outcomes, both measured at the end of the study period. For PTSD symptom severity, scores were measured using a structured interview called the CAPS-5, which runs from 0 to 80 (higher numbers mean more severe symptoms). The reported average score at the end of the study was 25.92 for the LKM group and 28.02 for the CPT-C group. For depression, a standardised questionnaire called the PROMIS scale was used, where a score of 50 represents the general population average. The reported average score was 58.88 for the LKM group and 61.22 for the CPT-C group. No data on the starting (baseline) scores was included in the structured results provided to ClinicalTrials.gov, so the full picture of how scores changed over time was not reported in this dataset. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01921179 · results posted 17 February 2020

    According to the results reported on ClinicalTrials.gov, this trial compared two programmes for people dealing with difficulties in attention and thinking: one called GOALS (Goal-Oriented Attentional Regulation), which focused on mental strategies for managing attention, and one called EDU (Brain Health Education), which served as a comparison programme covering general brain health information. In the main five-week phase, 24 people started in the GOALS group and 22 in the EDU group, with 21 and 19 completing it respectively. A separate longer-term follow-up phase then tracked 34 GOALS participants (32 of whom completed it) at six or more months after training. The trial measured changes in attention and thinking skills, ability to carry out complex everyday tasks, and self-reported mood. The reported data shows the following numbers for the main comparison after the five-week programme. For attention and thinking skills, scores are expressed as "z-scores" — a way of showing how far a result sits from the average of a reference population, where zero equals the average, negative numbers are below it, and positive numbers are above it. The GOALS group recorded a z-score of −0.03 and the EDU group recorded −0.39. For the complex everyday task measure (scored on a scale of 0–10, where higher means better), the GOALS group scored 8.10 and the EDU group scored 7.60. For the mood disturbance measure (also a z-score, where more negative means less distress relative to the reference population), the GOALS group scored −1.37 and the EDU group scored −2.09. At the six-months-plus follow-up, only the GOALS group was measured: their attention and thinking z-score was −0.20, their everyday task score was 8.23, and their mood disturbance z-score was −1.01. The trial report does not include statistical comparisons or confidence intervals in the submitted data, so no further interpretation of these numbers can be drawn from what was reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01338506 · results posted 11 February 2020

    According to the results reported on ClinicalTrials.gov, this trial involved 81 people in total — 54 assigned to a therapy called COPE (Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure) and 27 assigned to a "treatment as usual" group, which served as a comparison. The trial was measuring changes in post-traumatic stress disorder (PTSD) symptoms and alcohol/substance use over time. Of those who started, 29 people in the COPE group and 13 in the treatment-as-usual group completed the study. The reported data shows that, by the end of the study, participants in the COPE group had an average PTSD score (measured by a clinician-administered interview called the CAPS, which runs from 0 to 136) of 27.2, compared to 49.7 in the treatment-as-usual group. In terms of how much scores changed from the start, the COPE group showed an average drop of 51.2 points on the CAPS, while the treatment-as-usual group showed an average drop of 35.9 points. A second PTSD measure (a self-completed checklist) showed average end-of-study scores of 37.6 for the COPE group and 53.1 for the treatment-as-usual group. For alcohol use, the reported data shows an average of 4.6 standard drinks per drinking day in the COPE group and 5.0 in the treatment-as-usual group. On a depression scale (scored 0–30), the COPE group averaged 13 and the treatment-as-usual group averaged 19.4. For abstinence from substances, 22 participants in the COPE group and 7 in the treatment-as-usual group reported being abstinent at the end of the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00648375 · results posted 2 January 2020

    According to the results reported on ClinicalTrials.gov, this trial (NCT00648375) enrolled a very small number of participants — just 3 people in total, with 1 person in the propranolol group and 2 people in the placebo group. All 3 participants completed the study. The trial was measuring whether propranolol (a medication sometimes used for heart conditions and anxiety) compared to a placebo (a dummy treatment) had any association with changes in PTSD (post-traumatic stress disorder) symptoms, depression, self-reported trauma symptoms, and general psychological distress, all tracked over multiple time points using standard questionnaires. The reported data shows the following score changes across the measurement periods. For the main (primary) outcome — a clinician-rated PTSD symptom scale scored from 0 to 70, where higher means more severe — the propranolol participant's scores moved from 58 down to 32 across the study, while the placebo group's scores moved from around 59 down to 35. For depression (scored 0–30), propranolol scores went from 12 to 7, and placebo from 13 to 7.5. For the self-reported trauma symptom scale (scored 0–51), propranolol went from 36 to 18, and placebo from 42.5 to 26.5. For the general distress scale (scored 0–72), propranolol went from 28 to 26, and placebo from 41 to 25. The reported data shows scores appeared to decrease over time in both groups across all measures. It is important to note that with only 3 participants total, this trial was extremely small, and the reported numbers describe only those specific individuals. No broader conclusions can be drawn from data of this size. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03132220 · results posted 9 December 2019

    According to the results reported on ClinicalTrials.gov, this trial enrolled 131 participants in total — 65 in a mindfulness-based cognitive therapy (MBCT) programme and 66 in a book club comparison group. By the end of the study, 47 people in the MBCT group and 54 in the book club group had completed all sessions. The trial was measuring changes in resilience (the ability to cope with stress and adversity) as the main focus, and also tracked satisfaction with the sessions, signs of burnout, post-traumatic stress symptoms, and anxiety as secondary measures. The reported data shows that on the resilience scale (scored 0–100, where higher means more resilient), the MBCT group started at an average of 67.6 and finished at 72.3, while the book club group started at 66.9 and finished at 73.6. For session satisfaction (scored 1–32), scores across four time points ranged from 25.4 to 28.2, with the MBCT group's scores rising slightly more over time than the book club group's. On the emotional exhaustion part of the burnout survey (scored 0–54, higher meaning more exhaustion), the book club group went from 26.4 to 24.9, while the MBCT group went from 29.2 to 29.0. For anxiety (scored 0–21, higher meaning more anxiety), the book club group went from 9.6 to 8.0, and the MBCT group from 9.0 to 8.6. On the post-traumatic stress intrusion score (scored 0–15), the book club group moved from 3.9 to 3.7, and the MBCT group from 4.3 to 4.5. No numerical data was reported for the qualitative interviews component. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT03765138 · results posted 26 November 2019

    According to the results reported on ClinicalTrials.gov, this trial (NCT03765138) enrolled only one participant, who was assigned to receive a combination treatment referred to as PE/Pramipexole. The study was designed to measure changes in PTSD symptoms and depressive (low mood) symptoms before and after treatment, as well as changes in how certain brain regions communicate with each other, as seen on brain scans. The trial did not complete as planned — the one participant who started did not finish the study. The reported data shows that no outcome measurement results were recorded for any of the three measures the trial set out to assess. These included a structured interview called the CAPS-5 (used to rate PTSD symptom severity on a scale of 0 to 80), a questionnaire called the Hamilton Rating Scale for Depression (used to rate low mood symptoms on a scale of 0 to 61), and brain scan data looking at how fear and reward-related brain regions connect with each other. Because the single participant did not complete the trial, no before-and-after numbers were reported for any of these measures. Given that only one person was enrolled and no results data was submitted, the reported data shows essentially no findings to describe from this trial. It is not possible to draw any conclusions about the treatment based on this information. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01816061 · results posted 11 September 2019

    According to the results reported on ClinicalTrials.gov, this trial (NCT01816061) involved two groups of participants — 40 people in the experimental group and 51 in the control group, making 91 people in total at the start. The trial was measuring two things after two months: how well participants were reintegrating into their communities (using a tool called the Community Reintegration for Injured Service Members scale, or CRIS), and changes in certain thinking and behaviour patterns linked to the front part of the brain (using a tool called the Frontal Systems Behavior Scale, or FrSBe). It is worth noting that not everyone completed the trial — 27 people finished in each group, meaning 13 from the experimental group and 24 from the control group did not complete it. The reported data shows that on the CRIS scale — which measures how much people felt they could participate in their community, with scores ranging from 28 to 64 and higher scores indicating more participation — the experimental group scored an average of 40.22 and the control group scored an average of 37.79 at the two-month point. For the FrSBe scale — which measures certain behaviour and thinking patterns, with scores ranging from 21 to 158 and higher scores indicating more difficulty — the experimental group averaged 85.4 and the control group averaged 84.3. The reported data does not include the baseline (starting) scores, so the precise change from the beginning of the trial for each group was not separately reported in the structured results provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01947647 · results posted 28 August 2019

    According to the results reported on ClinicalTrials.gov, this trial compared two types of talking therapy for people experiencing emotional health difficulties — one called Transdiagnostic Behaviour Therapy and the other called Behavioural Activation. A total of 93 people took part (46 in the Transdiagnostic group and 47 in the Behavioural Activation group). The trial measured symptoms of depression, anxiety, and stress using questionnaire scores, as well as how much participants felt their condition interfered with daily life. Participants were assessed during the treatment phase and again at a six-month follow-up. It is worth noting that a notable number of participants did not complete the trial — 17 out of 46 in the Transdiagnostic group and 26 out of 47 in the Behavioural Activation group did not finish the treatment phase. The reported data shows the following average scores across both time points (treatment end and six-month follow-up). On the depression scale (scored 0–21, where higher means more severe), the Transdiagnostic group scored 3.93 and then 4.51, while the Behavioural Activation group scored 5.91 and then 6.01. On the anxiety scale (also 0–21), scores were 4.05 then 4.14 for the Transdiagnostic group, and 3.86 then 4.15 for the Behavioural Activation group. On the stress scale (0–21), the Transdiagnostic group recorded 5.94 then 6.29, and the Behavioural Activation group recorded 5.00 then 5.93. Two further anxiety questionnaires (covering thinking-related and physical symptoms of anxiety, scored on different ranges) also showed broadly similar figures between the two groups across both time points. On the scale measuring how much the condition interfered with daily life (scored 13–91), the Transdiagnostic group scored 33.13 then 32.85, while the Behavioural Activation group scored 33.84 then 29.77. It is important to note that the data as submitted does not include information about what scores looked like *before* treatment began, so the reported numbers above reflect only the points at which measurement was taken during and after therapy. No before-and-after comparison figures were included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02724787 · results posted 19 August 2019

    According to the results reported on ClinicalTrials.gov, this trial (NCT02724787) enrolled 24 participants in a single open trial group — meaning everyone received the same treatment with no comparison group. Twenty-two participants completed the study, and two did not finish. The trial was measuring aggression, difficulties with managing emotions, and participants' views on the therapist and a treatment called MERA, using several self-report questionnaires filled in by participants themselves. The reported data shows the following numbers at the end of the study. On the Overt Aggression Scale — which counts how often different aggressive acts occur, with higher numbers meaning more frequent aggression — the average reported score was 14.2 (there is no fixed upper limit on this scale). On the Difficulties in Emotion Regulation Scale — scored from 36 to 180, where higher scores mean greater difficulty managing emotions — the average reported score was 107.45. On the Emotion Regulation Questionnaire, which looks at two strategies for handling emotions, the average score for "cognitive reappraisal" (changing how one thinks about a situation) was 16.85 out of a possible 42, and the average score for "expressive suppression" (holding emotions in without showing them) was 26.55 out of a possible 28. Regarding participants' views of the therapist and treatment — rated on a 1-to-4 scale — the reported averages were 3.94 for how understanding the therapist was, 3.68 for how helpful the therapist was in teaching skills, and 3.15 for how helpful MERA was in managing emotions. When asked about specific skills they were using in the week before the end of treatment, the numbers of participants reporting use of each of the eight skills were 17, 14, 14, 14, 12, 12, 12, and 7 respectively (the names of the individual skills were not included in the reported data). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02560389 · results posted 25 June 2019

    According to the results reported on ClinicalTrials.gov, this trial enrolled 91 people across three groups: 34 received a placebo (a dummy treatment with no active ingredient), 28 received a 100 mg dose of L-DOPA (a drug that affects dopamine levels in the brain), and 29 received a 200 mg dose of L-DOPA. Most participants completed the study — 33, 25, and 27 people respectively finished in each group. The trial was measuring how the body and brain responded to a fear-conditioning task, which involved pairing images with mild shocks to see how the nervous system learns to associate certain signals with threat. Three things were measured: a skin sweating response (galvanic skin response, a way of detecting emotional arousal through tiny changes in skin moisture), and brain activity in two regions — the amygdala (a brain area involved in emotions and threat responses) and the anterior cingulate cortex (a brain area involved in attention and emotional regulation). The reported data shows that for the primary measure — the skin sweating response — the placebo group recorded a value of 0.37, the 100 mg L-DOPA group recorded 0.29, and the 200 mg L-DOPA group recorded 0.36. These figures represent the difference in the skin response between a "threat" signal and a neutral signal during the task. For the secondary measures, the reported data shows that amygdala brain activity (expressed as percentage change) was -0.10 in the placebo group, -0.06 in the 100 mg group, and -0.05 in the 200 mg group. Activity in the anterior cingulate cortex showed a percentage change of 0.08 in the placebo group, 0.09 in the 100 mg group, and 0.07 in the 200 mg group. No further statistical analysis or context for these numbers was included in the data reported to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02233517 · results posted 31 May 2019

    According to the results reported on ClinicalTrials.gov, this trial compared two group therapy programmes for veterans dealing with anger and aggression: Cognitive Behavioral Therapy (CBT) and Present Centered Therapy (PCT). A total of 36 participants were enrolled — 19 in the CBT group and 17 in the PCT group. Of those, 12 CBT participants and 13 PCT participants completed the study. The trial measured anger, aggressive behaviour, and day-to-day functioning at the start of the programme, after treatment ended, and again at three and six months later. The reported data shows the following across the three primary measures. For physically aggressive behaviours (scored 0–6, where lower means less frequent), the CBT group's average scores went from 0.50 at the start to 0.94 at the six-month follow-up, while the PCT group went from 1.24 to 1.18. For the anger reactions scale (scored 0–56, where lower means less impact), CBT participants averaged 40.2 at the start and 35.5 at six months; PCT participants averaged 41.2 at the start and 36.1 at six months. For the anger and coping scale (scored 0–100, where lower means less impact), CBT scores moved from 74.2 to 74.7 and PCT scores from 75.9 to 76.1 across the same period. For the secondary measures of broader daily functioning and social participation, the reported data shows relatively small numerical changes across both groups between the start of the study and the follow-up time points, with scores remaining in a similar range throughout. It is worth noting that this was a small study with fewer than 20 people in each group, and the data as submitted does not include information about whether any differences between the two groups were statistically meaningful — meaning the figures alone cannot tell us whether any changes observed were greater than what might happen by chance. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01653288 · results posted 26 February 2019

    According to the results reported on ClinicalTrials.gov, this trial looked at an online program called "Coping Coach," designed for children who had experienced a traumatic event. A total of 72 children took part — 36 in the Coping Coach group, who got access to the program straight away, and 36 in a waitlist control group, who waited before getting access. The trial was primarily measuring whether the online program was practical to use (called "feasibility"), and also collected some early, exploratory data on several child wellbeing scores. The reported data shows that, of the 36 children in the immediate Coping Coach group, 35 logged in at least once, and 19 completed the entire program. In the waitlist group (who accessed the program later), 19 logged in at least once and 15 completed it. On average, children in both groups spent around 52 minutes using the program across all their sessions. Four questionnaires were used to track children's experiences at different time points. These measured stress symptoms after trauma (scored 0–51, higher = more severe), quality of life (scored 0–100, higher = better), use of avoidance-style coping (scored 12–48, higher = more avoidance), and unhelpful thought patterns after trauma (scored 25–100, higher = more unhelpful thoughts). The reported scores for both groups at the various time points ranged across these scales — for example, stress symptom scores ranged roughly from the low-to-mid thirties to the mid-forties across the groups and time points — but the trial was not designed to draw firm conclusions from these numbers, and the researchers described this part as a "preliminary" look only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01963078 · results posted 11 December 2018

    According to the results reported on ClinicalTrials.gov, this trial (NCT01963078) enrolled 38 people across four groups. Some participants had PTSD and others were described as "resilient" (meaning they did not have PTSD and served as a comparison group). Each person took part in two brain-scanning sessions — one where they received a nasal spray containing oxytocin (a naturally occurring hormone) and one where they received a placebo (an inactive nasal spray with no oxytocin). The order was randomised, so some people received oxytocin first and others received it second. The trial was measuring activity in a part of the brain called the amygdala — a region involved in processing emotions — while participants completed a facial recognition task inside a brain scanner. Thirty-three of the 38 people who started the trial completed it. The reported data shows the main outcome was the change in brain activity in the amygdala when comparing the oxytocin session to the placebo session. This was measured as a percentage change in a brain-scanning signal. For the two PTSD groups, the reported figures were very small negative numbers (−0.01% and −0.02%), meaning the amygdala signal was slightly lower during the oxytocin session compared to the placebo session. For the two resilient (non-PTSD) comparison groups, the figures were small positive numbers (0.05% and 0.21%), meaning the amygdala signal was slightly higher during the oxytocin session. No secondary outcome measures were included in the submitted results data. The trial did not report any additional outcome figures beyond these amygdala activity scores. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01611194 · results posted 21 November 2018

    According to the results reported on ClinicalTrials.gov, this trial enrolled 71 people in total — 36 in a group receiving hyperbaric oxygen therapy (breathing pure oxygen inside a pressurised chamber at 1.5 atmospheres of pressure) and 35 in a comparison "sham" group (a lower-pressure session designed to look like the real treatment). All 36 in the oxygen group completed the study, while 32 of the 35 in the sham group completed it. The trial was measuring two things: any unwanted health events (called adverse events) that occurred during or after the sessions, and changes in self-reported post-concussion symptoms — such as headaches, dizziness, and memory difficulties — using a standard questionnaire called the Rivermead Post-Concussion Symptom Questionnaire (RPQ), where higher scores indicate more severe symptoms. The reported data shows that, for adverse events (unwanted health events) that emerged during the study, 13 participants in the oxygen group and 5 in the sham group experienced at least one such event overall. When looking only at events considered related to the treatment itself, 11 participants in the oxygen group and 5 in the sham group were recorded as having experienced one. For the symptom questionnaire, both groups started with relatively high scores at the beginning of the study (the oxygen group averaged around 34.8 out of a possible 64, and the sham group around 28.2). The reported data shows changes from those starting scores varied across different follow-up time points — for example, at one time point the oxygen group's total score changed by −0.7 (a very slight decrease) while the sham group's changed by +5.8 (an increase), and at another time point both groups showed a change of approximately +5.5 to +5.7. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01884025 · results posted 5 November 2018

    According to the results reported on ClinicalTrials.gov, this trial (NCT01884025) involved two groups of older adults. Thirteen people were enrolled in the "Get Moving and Get Well" group (a physical activity programme) and 14 in the "Health and Humor Class" group (a comparison programme). Ten people in each group completed the study, with three and four participants respectively not finishing. The trial was measuring changes in several areas over time, including behavioural activation (a measure of how engaged and active people are in daily life), exercise confidence, physical activity levels, general health, depression symptoms, and intention to take part in healthy activities. The reported data shows the following changes from the start to the end of the trial. On the main measure — the Behavioural Activation for Depression Scale — the "Get Moving" group scored changes of 1.3, 2.8, 4.8, 3.6, and 12.5 across its five sub-sections, while the "Health and Humor" group scored 1.2, 3.0, 12.0, 1.1, and 6.5 on those same sections (higher scores on this scale reflect the scale's named quality, for example higher "Activation" means more activation). On exercise confidence, the "Get Moving" group showed a change of 1.5 units and the "Health and Humor" group 0.6 units. For physical activity frequency, the "Get Moving" group showed changes of 2.7 and 1.3 times per week across two activity categories, compared with 4.3 and 2.1 for the "Health and Humor" group. On the general health measure, physical health scores changed by +0.54 ("Get Moving") and −2.51 ("Health and Humor"), while mental health scores changed by +7.52 and +3.31 respectively. Depression symptom scores changed by −1.30 ("Get Moving") and −0.50 ("Health and Humor"), where a negative number means scores went down. Finally, intention to engage in healthy activities changed by −1.80 ("Get Moving") and +3.10 ("Health and Humor"). It is worth noting that this was a small pilot study with around 10 completers per group, and the reported data does not include information on whether differences between the two groups were statistically meaningful (meaning whether they could be due to chance). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00805532 · results posted 5 November 2018

    According to the results reported on ClinicalTrials.gov, this trial involved 81 people in total — 42 in a group that received a therapy called Behavioural Activation (BA), and 39 in a group that received Treatment as Usual (TAU). Nearly all participants completed the study (42 in the BA group and 38 in the TAU group). The trial was measuring symptoms of post-traumatic stress disorder (PTSD), depression, and everyday functioning across several questionnaire-based scales, comparing the two groups at different points in time. The reported data shows that on the main measure — the Clinician Administered PTSD Scale (CAPS-IV, scored 0–136, where higher means more severe symptoms) — the BA group started with an average score of 75.9 and the TAU group started at 82.0. At a later time point, the BA group's average score was reported as 54.4, while the TAU group's was 70.1, with a further reading of 56.25 (BA) and 64.6 (TAU). On a self-reported PTSD checklist (PCL-M, scored 17–85), both groups started at 59.0, with later readings of 44.1 (BA) and 52.6 (TAU), then 48.0 (BA) and 51.4 (TAU). For depression (BDI-II, scored 0–63), starting scores were similar (24.8 BA; 25.2 TAU), with later readings of 17.5 (BA) and 23.3 (TAU), then 21.0 (BA) and 21.5 (TAU). The reported data also shows results for two further measures. On the Sheehan Disability Scale (0–30, higher meaning more impairment in daily life), starting scores were 19.0 (BA) and 18.0 (TAU), with later readings of 15.0 (BA) and 16.0 (TAU), then 15.9 (BA) and 16.1 (TAU). On the Behavioural Activation Scale (0–150, higher meaning more activity and engagement), starting scores were 76.0 (BA) and 74.2 (TAU), with later readings of 89.5 (BA) and 82.0 (TAU), then 79.4 (BA) and 83.8 (TAU). The data does not specify the exact time points these measurements were taken, so the timing of each reading was not reported in the structured results available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02661828 · results posted 25 September 2018

    According to the results reported on ClinicalTrials.gov, this trial (NCT02661828) was designed to look at what happens when people stop taking antidepressant medication, specifically measuring any withdrawal-like symptoms that can appear during that process. The trial compared two tapering schedules — called "Taper A Regimen" and "Taper B Regimen" — for coming off antidepressants. However, the reported data shows that only one person was enrolled in the entire study (in the Taper A group), and no participants were enrolled in the Taper B group. Because so few people took part, the results are extremely limited in scope. The reported data shows that for the one participant in the Taper A group, scores on the main symptom checklist (the DESS, a 43-point scale where higher numbers mean more symptoms reported) were 0 at one point in time and 6 at another. On a second checklist measuring symptom intensity (the PWC-20, a 60-point scale where higher numbers mean more severe symptoms), the score was reported as 15 at both time points. The reported data also shows that this one participant met the study's definition of "Antidepressant Discontinuation Syndrome," meaning they reported four or more new or worsened symptoms at a visit during the study. No data was reported for the Taper B group. Because only a single participant completed this trial, the numbers above reflect just one person's experience and cannot be used to draw broader conclusions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01901848 · results posted 11 September 2018

    According to the results reported on ClinicalTrials.gov, this trial involved 50 people who smoked, split evenly into two groups of 25. One group received a combination treatment called CPT plus ICSC (a type of cognitive processing therapy combined with individual smoking cessation counselling), and the other received a present-focused version of the counselling on its own (Present-focused ICSC). The trial was measuring how many people in each group had stopped smoking by six months after their planned quit date. The reported data shows that at the six-month follow-up, 2 out of 25 people in the CPT+ICSC group reported not having smoked in the previous seven days, compared with 8 out of 25 in the Present-focused ICSC group. To check these self-reports, participants also took a breath test measuring carbon monoxide levels — a way of cross-checking whether someone has been smoking. The reported data shows that 2 people in the CPT+ICSC group and 4 people in the Present-focused ICSC group passed this breath test at the six-month mark. It is also worth noting that 10 participants in the CPT+ICSC group were removed from the final analyses, compared with none in the other group, which means the numbers above come from different-sized pools of participants. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02372396 · results posted 5 September 2018

    According to the results reported on ClinicalTrials.gov, this trial (NCT02372396) enrolled 37 veterans across two groups — 17 in the CBCT-Vet group and 20 in the Veteran.Calm group. The trial was measuring the severity of PTSD (post-traumatic stress disorder) symptoms in veterans using a structured clinical interview called the CAPS-5, which produces a score between 0 and 80, where a higher number means more severe symptoms. Of those who started, 14 in each group went on to begin the intervention, and 10 and 11 respectively completed the study. The reported data shows that at the start of the study, the average PTSD symptom score for the CBCT-Vet group was 35.8, and for the Veteran.Calm group it was 37.9 — both sitting in a similar range. By the end of the study, the reported average score for the CBCT-Vet group was 20.4, while the Veteran.Calm group's average score was 35.3. These are the numbers as submitted; the trial data does not include additional secondary outcome results to report here, so no further figures are available from this record. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02499029 · results posted 29 August 2018

    According to the results reported on ClinicalTrials.gov, this trial enrolled 35 people in total — 18 received N-Acetylcysteine (a supplement sometimes used in medical settings) and 17 received a placebo (a dummy pill with no active ingredient). The trial was looking at people with PTSD and measured their PTSD symptoms as the main focus, along with depression levels and alcohol cravings as additional areas of interest. By the end of the trial, 13 people in the N-Acetylcysteine group and 14 in the placebo group had completed the study. The reported data shows that PTSD symptom severity — measured using a clinician-rated scale scored from 0 to 136, where higher numbers mean more severe symptoms — started at an average of 38.7 for the N-Acetylcysteine group and 52.8 for the placebo group, and finished at 32.0 and 51.5 respectively. For depression, measured on a scale of 0 to 63, the N-Acetylcysteine group started at 10.9 and ended at 9.9, while the placebo group started at 18.5 and ended at 19.3. A separate self-reported PTSD checklist (scored 17–85) showed starting scores of 33.8 (N-Acetylcysteine) and 41.9 (placebo), ending at 31.2 and 41.9 respectively. Alcohol craving, rated on a 0–10 scale across multiple time points, was reported as ranging between 0.7 and 1.8 for the N-Acetylcysteine group and between 2.4 and 3.0 for the placebo group across those same points. It is worth noting that the two groups appeared to have different starting scores across several measures, which makes straightforward comparison of the numbers more complicated. The reported data does not include statistical analysis results in the information submitted to ClinicalTrials.gov, so no conclusions about whether any differences between groups were meaningful can be drawn from this summary alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02398227 · results posted 10 August 2018

    According to the results reported on ClinicalTrials.gov, this trial involved 172 people in total — 83 in a group receiving a therapy called HOPE and 89 in a group receiving a therapy called Present Centred Therapy (PCT). Both are talking therapies. The trial was measuring two things: symptoms of post-traumatic stress disorder (PTSD), using a clinician-led interview called the CAPS (scored 0–136, where higher means more severe symptoms), and the level of violence or abuse experienced, using a scale called the SVAWS (scored 0–138, where higher means more severe). By the end of the study, 56 people in the HOPE group and 71 in the PCT group had completed the trial, with 27 and 18 respectively not completing it. The reported data shows the following CAPS scores (adjusted averages) at four time points for HOPE and PCT respectively: at the first time point, 48.08 and 52.39; at the second, 31.75 and 34.43; at the third, 29.36 and 32.63; and at the fourth, 27.32 and 29.00. For the SVAWS violence scale, the reported adjusted average scores across the same four time points were: 7.81 and 13.89; then 3.47 and 1.10; then 3.42 and 2.73; and finally 2.40 and 3.68. The reported data does not include labels identifying exactly when each time point occurred, so the precise timing of each measurement was not reported in a way that allows further clarification here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01408641 · results posted 24 May 2018

    According to the results reported on ClinicalTrials.gov, this trial (NCT01408641) was set up to compare topiramate (a medication) against a placebo (a sugar pill with no active ingredient) in people with heavy alcohol use. The trial aimed to measure two things: the percentage of days participants drank heavily, and the level of PTSD (post-traumatic stress disorder) symptoms they experienced. Only 1 person was enrolled in the topiramate group, and no one was enrolled in the placebo group — meaning the trial did not proceed in any meaningful way. That single participant did not complete the study. The reported data shows that no results were recorded for either the primary outcome (percentage of heavy drinking days) or the secondary outcome (PTSD symptom scores). Because the trial enrolled just one participant and that person did not complete it, no measurements were available to report for either group. This means there is effectively no findings data from this trial to describe. The data was simply not reported, most likely because the study was unable to run as planned. It is not known from the information submitted why enrolment fell so short of what would have been needed. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02520726 · results posted 10 April 2018

    According to the results reported on ClinicalTrials.gov, this trial (NCT02520726) enrolled a total of 5 participants — 3 in the sertraline group and 2 in the placebo group. The trial was designed to compare sertraline (an antidepressant medication) against a placebo (an inactive dummy treatment) in people with post-traumatic stress disorder (PTSD). The two main things the trial set out to measure were PTSD symptom severity (using a standard clinician-administered rating scale) and thoughts of suicide (using a separate questionnaire). The reported data shows that none of the 5 participants completed the study — all 3 in the sertraline group and both participants in the placebo group did not finish. Because of this, the reported data contains no numerical results for either the primary outcome (PTSD symptom scores) or the secondary outcome (suicide ideation scores). In other words, no outcome measurement data was reported to ClinicalTrials.gov for either measure. Given that the trial ended without any participants completing it and no outcome numbers were recorded, there are no findings from this study that can be described or interpreted. The reasons why participants did not complete the trial were not reported in the data available on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01524133 · results posted 28 February 2018

    According to the results reported on ClinicalTrials.gov, this trial looked at three different treatment approaches for post-traumatic stress disorder (PTSD) in a total of 207 adults. The three groups were: a medication called sertraline combined with enhanced medication management (71 people); a talking therapy called Prolonged Exposure combined with sertraline (69 people); and Prolonged Exposure combined with a placebo — a dummy pill with no active ingredient (67 people). The trial ran for 52 weeks and measured PTSD symptom levels as well as a range of physical complaints that can accompany stress. The reported data shows that PTSD symptoms were measured using a specialist-administered scale called the CAPS, which runs from 0 to 136, where higher numbers mean more severe symptoms. At the end of the treatment phase, the average scores reported were 41.7 for the sertraline plus enhanced medication management group, 43.3 for the Prolonged Exposure plus sertraline group, and 51.5 for the Prolonged Exposure plus placebo group. A second measure, the PHQ-15, tracked physical symptoms such as body aches and fatigue on a scale of 0 to 30 (where 0–9 is considered low, 10–14 moderate, and 15–30 severe). The reported average scores on this scale were 8.6, 9.8, and 10.5 for the three groups respectively. It is worth noting that not everyone finished the study — by the 52-week mark, 50, 49, and 40 participants respectively had completed the full period. The reported data shows the numbers above as they were submitted, but does not include information about what scores participants started with before treatment, so direct comparisons between groups should be interpreted with caution. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02453347 · results posted 28 February 2018

    According to the results reported on ClinicalTrials.gov, this trial (NCT02453347) enrolled 6 participants, all of whom completed the study. All 6 were placed in a single group that received Cranial Electrotherapy Stimulation (CES) Therapy — a treatment that delivers a low-level electrical current to the head. The trial was measuring scores across six different questionnaires and tests related to post-traumatic stress disorder (PTSD) symptoms, anxiety, depression, tinnitus (ringing in the ears), brain injury adaptability, and information processing speed. There was no comparison group, so all reported numbers come from this one group of six people. The reported data shows the following average scores across participants: on the PCL-5 (a PTSD symptom checklist scored 0–80, where higher means more severe), the average score was 44.25; on the STAI (an anxiety measure scored 40–160, where higher means more anxiety), the average was 81.375; on the Beck Depression Inventory (scored 0–63, where higher means more severe depression), the average was 25; on the Tinnitus Functional Index (scored 0–250, where higher means tinnitus interferes more), the average was 94.875; on the Mayo Portland Adaptability Inventory (scored 0–116, where lower means better adaptability after brain injury), the average was 48; and on the WAIS Symbol Search (a processing speed test scored 0–60, where higher means better performance), the average was 26.75. The reported data does not include scores from before the treatment began, so no before-and-after comparison figures were provided in the submitted results. It is worth noting that with only 6 participants and no comparison group, these numbers represent a very small snapshot. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02504931 · results posted 27 February 2018

    According to the results reported on ClinicalTrials.gov, this trial (NCT02504931) looked at sertraline (an antidepressant sometimes used for anxiety and trauma-related conditions) compared to a placebo (a dummy pill with no active ingredient) in people who had both post-traumatic stress disorder (PTSD) and heavy drinking. A total of 49 people started the trial — 26 in the sertraline group and 23 in the placebo group. Of those, 14 in the sertraline group and 13 in the placebo group completed the study. The remaining 12 and 10 participants respectively did not finish. The reported data shows that the main thing being measured was the percentage of days over 12 weeks on which participants reported "heavy drinking." According to the results reported on ClinicalTrials.gov, the sertraline group reported heavy drinking on approximately 55.5% of days, while the placebo group reported heavy drinking on approximately 65.1% of days. The trial also measured PTSD symptom severity using a standard 20-question checklist (scored from 0 to 80, where a higher number means more severe symptoms). The reported data shows an average score of 59.6 in the sertraline group and 61.7 in the placebo group at the end of the study. No further breakdown of these figures — such as scores at the start of the trial — was included in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01191333 · results posted 7 February 2018

    According to the results reported on ClinicalTrials.gov, this trial enrolled 164 people with depression — 81 in the group receiving active repetitive Transcranial Magnetic Stimulation (rTMS, a non-invasive brain stimulation technique) and 83 in a "sham" group (where the procedure was simulated but inactive, acting as a comparison). By the end of the study, 60 people in the active group and 65 in the sham group had completed the trial. The trial was measuring whether rTMS could bring about "remission" from depression — meaning a significant reduction in depression symptoms as measured by a standardised rating scale completed by a clinician (the Hamilton Rating Scale for Depression, scored from 0 to 76, where higher scores indicate more severe symptoms). The reported data shows that for the primary measure — the number of participants whose depression scores fell low enough to be classified as being in remission — 33 out of 81 people in the active rTMS group and 31 out of 83 in the sham group reached that threshold by the end of the acute treatment phase. The reported data also shows results from several secondary measures, which tracked mood and wellbeing using questionnaires filled in by participants themselves. For depression symptoms (measured by the Beck Depression Inventory, scored 0–63), scores moved from 14.2 to 9.0 in the active group and from 13.0 to 12.8 in the sham group. For another clinician-rated depression scale (MADRS, scored 0–60), scores went from 14.3 to 13.7 in the active group and from 13.1 to 15.0 in the sham group. Suicidal thinking scores (Beck Scale, 0–38) moved from 2.0 to 1.5 (active) and 2.7 to 2.5 (sham). Scores measuring general mental and physical wellbeing (VR-36, 0–100, where higher is better) showed modest changes in both groups, with full details available on ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01739335 · results posted 24 January 2018

    According to the results reported on ClinicalTrials.gov, this trial enrolled 81 people with PTSD (post-traumatic stress disorder) — 41 were assigned to take mifepristone (a tablet, 600 mg per day) and 40 received a sugar pill (placebo) for comparison. The trial was measuring changes in PTSD symptoms using a structured interview called the CAPS scale, which produces a score from 0 to 136 where higher numbers mean more severe symptoms. The main question the trial set out to answer was how many participants showed a meaningful improvement — defined as a drop of at least 30% in their symptom score — four weeks after the treatment period ended. The reported data shows that at the four-week follow-up, 15 out of 34 participants who completed the mifepristone group met that 30% improvement threshold, compared with 12 out of 26 in the sugar-pill group. At the 12-week follow-up (the end of the study), the reported data shows 10 out of 22 participants in the mifepristone group and 14 out of 21 in the sugar-pill group reached that threshold. Looking at the average change in overall symptom scores, both groups showed reductions from their starting scores: at four weeks, the mifepristone group's score dropped by an average of about 14 points and the sugar-pill group's by about 16 points; at 12 weeks, the drops were approximately 15 points and 18 points respectively. Similar patterns — reductions in both groups across all symptom categories — were reported for the sub-scores covering intrusive memories, avoidance, and hyperarousal (feeling on edge). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02701361 · results posted 10 January 2018

    According to the results reported on ClinicalTrials.gov, this trial enrolled 80 participants across three groups: a Mobile Mindfulness group (31 people), a Standard Mindfulness group (31 people), and an Education Group (18 people). The trial was not primarily testing whether the programs improved health — instead, it was a **feasibility study**, meaning it was designed to check whether running a larger trial would be practical. The researchers measured things like how many eligible people agreed to join, how many stayed until the end, and how satisfied participants were with what they received. The reported data shows that 90% of eligible people who were approached agreed to take part, and 80% of eligible participants went on to be formally enrolled and randomly placed into one of the three groups — both figures above the targets the researchers had set in advance. Satisfaction with the programmes, measured using a questionnaire scored from 9 (lowest) to 36 (highest), came in at 27.6 for the Mobile Mindfulness group, 29.4 for the Standard Mindfulness group, and 25.7 for the Education Group, all well above the target of more than 10. For the mobile app specifically, usability was measured on a separate scale from 0 to 100, and the Mobile Mindfulness group reported an average score of 86.5, which the scale's designers describe as above average (above 68). The reported data also shows that the number of people who did not complete the study was relatively low: in the Mobile Mindfulness group 9 out of 31 did not finish, compared with 3 out of 31 in the Standard Mindfulness group and 2 out of 18 in the Education Group. Of those who did remain in the study, 22, 28, and 16 participants respectively completed their telephone interviews. The data as submitted does not include a separate reported percentage figure for dropout rate per group, so a precise percentage breakdown was not available to report here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01000493 · results posted 1 September 2017

    According to the results reported on ClinicalTrials.gov, this trial (NCT01000493) enrolled 129 people with post-traumatic stress disorder (PTSD) — 60 in the placebo group and 69 taking a daily 60 mg dose of orvepitant. The trial ran for 12 weeks and its main goal was to measure changes in PTSD symptom severity using a structured interview called the CAPS scale, which runs from 0 (few or no symptoms) to 136 (extreme symptoms), with higher scores meaning greater severity. It is worth noting that a large number of participants did not complete the study — 39 out of 60 in the placebo group and 55 out of 69 in the orvepitant group. The reported data shows that for the primary measure — change in CAPS score from the start to week 12 — the placebo group's average score fell by about 25.8 points, while the orvepitant group's average score fell by about 31.4 points. For the secondary measures, the reported data shows that by week 12, around 52% of placebo participants and 79% of orvepitant participants had a score reduction of 30% or more from their starting point. Regarding "remission" (reaching a CAPS score below 20, meaning few or no symptoms), the reported data shows low figures in both groups at week 12 — 10% for placebo and 7% for orvepitant. The reported median time to reaching a sustained response was 35.5 days for the placebo group and 30.0 days for the orvepitant group. For a sub-score specifically tracking "re-experiencing" symptoms (such as flashbacks), the reported data shows average reductions of 10.0 points (placebo) and 12.9 points (orvepitant) by week 12. No safety or side-effect data was included in the structured results submitted to ClinicalTrials.gov, so that information was not reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02642536 · results posted 7 August 2017

    According to the results reported on ClinicalTrials.gov, this trial (NCT02642536) involved 44 people in total — 21 in a group called "MH MOVE" and 23 in a group called "Enhanced Usual Care." By the end of the study, 19 people in the MH MOVE group and 18 in the Enhanced Usual Care group had completed it, meaning 2 and 5 people respectively did not finish. The trial was measuring things like how many weight-management sessions (called MOVE! sessions) people attended, how many days they spent doing vigorous physical activity, how confident they felt about eating well during difficult times, and how severe their depression symptoms were — all assessed at the start and after 16 weeks. The reported data shows that, on average, both groups attended a similar number of MOVE! sessions — 5.9 sessions for the MH MOVE group and 5.8 for the Enhanced Usual Care group (out of a possible 2–12). For vigorous physical activity, the reported starting scores were close — 27.7 for MH MOVE and 28.1 for Enhanced Usual Care (on a scale of 0–32). At 16 weeks, the reported scores were 21.5 for MH MOVE and 26.9 for Enhanced Usual Care (on a scale of 0–48, where higher means more active days). For confidence in eating well during tough times (scored 20–100, higher meaning more confident), the MH MOVE group started at 32.3 and the Enhanced Usual Care group at 29.8; at 16 weeks these figures were 29.9 and 23.2 respectively. The reported data also shows a secondary measure of depression symptom severity (scored 0–24, where higher means more severe symptoms). At the reported time point, the MH MOVE group scored 6.3 and the Enhanced Usual Care group scored 13.4, though the data does not clearly separate whether these were baseline or follow-up figures for this measure. It is worth noting that these are average scores across small groups of participants, and no further breakdown or context was provided in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT02274688 · results posted 24 July 2017

    According to the results reported on ClinicalTrials.gov, this trial enrolled 171 people who had experienced a traumatic injury — 86 in a group receiving "Enhanced Usual Care" (where nurses were notified of patient concerns) and 85 in a "Patient-centred Care Transition" group. The trial followed participants for six months after their injury and measured several things: how many people had serious post-traumatic worries, symptoms of post-traumatic stress disorder (PTSD), depression symptoms, alcohol use, physical functioning, and thoughts of suicide. A total of 144 people (72 in each group) completed the study. The reported data shows the following across four points in time (baseline, and follow-ups over six months). For serious post-traumatic concerns, the number of participants reporting at least one severe concern started at 80 (usual care) and 83 (care transition), and by the final time point had moved to 42 and 33 respectively. For PTSD symptoms — measured on a scale of 17 to 85, where higher means worse — scores started at roughly 42–43 in both groups and moved to around 39 and 39 by the end. For depression — measured on a scale of 1 to 27, higher meaning worse — scores started at roughly 14–15 and moved to around 11 and 9 by the final point. For alcohol use (scale 0–40, higher meaning worse), scores moved from around 3.4–3.7 down to 1.6–2.3. For physical functioning (scale 0–100, higher meaning better), scores moved from around 48 in both groups to roughly 40–42 by the end. For thoughts of suicide, the number of participants reporting any such thoughts was 19 and 22 at the start, and 16 and 17 at the final time point. The reported data shows numbers changing across both groups over the six months, but this summary does not draw any conclusions about whether one approach was better than the other — that interpretation requires careful clinical analysis. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01681849 · results posted 28 June 2017

    According to the results reported on ClinicalTrials.gov, this trial involved 84 people in total across three groups: 15 people who received the medication paroxetine, 13 who received a placebo (a dummy treatment with no active ingredient), and 56 people who did not have PTSD and were included for comparison purposes. The trial was measuring PTSD symptom severity using a structured questionnaire called the CAPS (Clinician-Administered PTSD Scale), which gives a score between 0 and 136 — with higher numbers meaning more severe symptoms. The trial also looked at changes in blood flow in certain parts of the brain before and after treatment. The reported data shows that, for the CAPS symptom score, the paroxetine group started with an average score of 31 and finished with an average score of 20, while the placebo group started with an average score of 30 and finished with an average score of 25. Regarding brain blood flow, the results were reported as a single summary figure (called a z-score, which reflects a statistical comparison rather than an individual measurement) — the paroxetine group had a z-score of 22 and the placebo group had a z-score of 2.68 under stress conditions after three months, compared to their starting point. The trial notes that the brain imaging software used could only produce one overall figure per group, so individual participant data for this measure was not available to report separately. It is also worth noting that a large number of participants did not complete the study — 8 out of 15 in the paroxetine group, 7 out of 13 in the placebo group, and 39 out of 56 in the PTSD-negative group did not finish — which the reported data does not explain in detail. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01542372 · results posted 17 May 2017

    According to the results reported on ClinicalTrials.gov, this trial (NCT01542372) involved 22 people in total — 11 in each of two groups. All 22 participants completed the study with no dropouts. The trial was looking at two different ways of adding to an existing treatment for PTSD (post-traumatic stress disorder) in Cambodian refugees: one group received an additional medication called prazosin, and the other received additional Cognitive Behavioural Therapy (CBT, a structured talking therapy). The study measured changes in PTSD symptom severity, as well as anxiety, depression, anger, physical complaints common among Cambodian refugees, and overall sense of wellbeing, all assessed over 12 weeks. The reported data shows that both groups had lower scores on the PTSD checklist (where a lower score means fewer reported symptoms) after 12 weeks. The medication group's score dropped by 5.0 points on average, while the CBT group's score dropped by 11.4 points on average, out of a possible scale of 17 to 85. For anxiety and depression — each measured on a 1-to-4 scale — the reported data shows small reductions in both groups, with the CBT group showing slightly larger drops (anxiety: −0.4 for medication, −0.6 for CBT; depression: −0.3 for medication, −0.5 for CBT). For anger and culturally specific physical complaints — each on a 0-to-4 scale — again both groups showed reductions, with the CBT group reporting larger changes (anger: −0.3 vs −0.9; physical complaints: −0.5 vs −0.9). Finally, for overall self-perceived functioning (scored 0–100, where higher is better), both groups reported improvements, with the medication group rising by 6.8 points and the CBT group by 10.2 points on average. It is important to note that this was a very small trial with only 11 people in each group, and the reported results describe what was measured and observed in those participants only. No conclusions about broader populations should be drawn from these numbers alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00431847 · results posted 15 May 2017

    According to the results reported on ClinicalTrials.gov, this trial enrolled 386 people in total across five groups. Participants were combat-injured service members who had lost or severely injured a limb. The trial looked at whether receiving a type of nerve-blocking pain treatment called regional anaesthesia (where local anaesthetic is delivered near specific nerves rather than throughout the whole body) — and how soon after injury it was given — was related to differences in pain reported months or years later. Four main groups were compared: those who received regional anaesthesia within 7 days of injury, those who received it between 8 and 14 days, those who received it more than 14 days after injury, and those who did not receive it at all. One additional participant had an unknown treatment status. The reported data shows that pain was measured using two questionnaires — the Neuropathic Pain Scale (NPS) and the Brief Pain Inventory (BPI) — both rated on a scale of 0 (no pain) to 10 (worst imaginable pain). For overall pain intensity on the NPS, scores ranged from 3.00 in the earliest regional anaesthesia group to 3.92 in the latest regional anaesthesia group, with the no-regional-anaesthesia group reporting 3.04. The combined NPS total score (averaging all ten pain questions) ranged from 2.29 in the no-regional-anaesthesia group to 2.80 in the latest regional anaesthesia group. For worst pain in the past week on the BPI, the earliest regional anaesthesia group reported 4.54, rising to 5.83 in the latest group, while the no-regional-anaesthesia group reported 4.62. Scores for how much pain interfered with daily activities (such as sleep, work, and mood) were similarly close across all groups, ranging from 1.88 to 2.57 out of 10. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00006489 · results posted 21 April 2017

    According to the results reported on ClinicalTrials.gov, this trial enrolled 165 adults who had both post-traumatic stress disorder (PTSD) and alcohol use problems. Participants were split into four groups: one group received the medication naltrexone plus supportive counselling; another received naltrexone plus a structured talking therapy called Cognitive Behavioural Therapy (CBT, specifically a technique called Prolonged Exposure); a third group received a placebo (a dummy pill with no active ingredient) plus CBT; and a fourth group received a placebo plus supportive counselling. The trial measured PTSD symptom severity and drinking behaviour at three points in time — before treatment began, at 24 weeks (end of treatment), and at 52 weeks (a follow-up check). Not everyone who started the trial finished it: between 25 and 32 people in each group completed the study. The reported data shows that PTSD symptom scores (rated on a scale of 0–51, where higher means more severe) started at similar levels across all four groups, ranging from about 27 to 30. By the end of treatment at 24 weeks, scores had dropped across all groups — to roughly 12–15 — and remained lower at the 52-week follow-up, sitting between about 8 and 11 across the groups. For drinking, participants were reporting drinking on roughly 71–79% of days before treatment. The reported data shows that by 24 weeks, the percentage of days drinking had fallen substantially across all groups, ranging from about 3.5% to 13.4%. At the 52-week follow-up, the reported figures ranged from approximately 8.8% to 27.3% across the four groups. For alcohol cravings (scored 0–30), all groups also showed lower scores at 24 weeks and at the 52-week follow-up compared to where they started, with follow-up scores ranging from about 6 to 9 across groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01477762 · results posted 18 April 2017

    According to the results reported on ClinicalTrials.gov, this trial enrolled 91 people in total across four groups. Participants were divided based on whether they screened positive or negative for PTSD (post-traumatic stress disorder), and each person took part in two sessions — one with a low dose of a steroid medication called dexamethasone and one with a placebo (a dummy pill with no active ingredient), in different orders. The trial was measuring how people learn and "unlearn" fear responses, using a standard laboratory method that tracks an involuntary eye-blink reaction to a sudden noise. The idea was to compare how well fear fades away (a process called extinction) under dexamethasone versus placebo, and whether this differed between people with and without PTSD. Not everyone completed the study — of the 91 who started, 63 finished. The reported data shows measurements in microvolts (a tiny unit of electrical activity recorded from the eye muscle). For the starting eye-blink reaction (baseline), figures ranged roughly from 43 to 116 microvolts depending on the group and whether they were on placebo or dexamethasone at that session. When a "danger signal" was shown, the eye-blink reaction was generally larger than baseline across all groups — for example, in the PTSD-positive group that received placebo first, it rose from around 116 microvolts at baseline to about 143 microvolts during danger-signal exposure. The reported data also shows a "fear-potentiated startle" score (the difference between the danger-signal reaction and the baseline). Early in the extinction phase, these difference scores ranged from roughly 17 to 43 microvolts across groups. By the late extinction phase — when the danger signal was no longer paired with anything unpleasant — the reported difference scores dropped substantially in most groups, with some groups showing scores close to zero or even slightly negative, while the PTSD-positive placebo-first group still showed a score of around 31 microvolts compared to roughly 2 microvolts in their dexamethasone session. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01466127 · results posted 14 April 2017

    According to the results reported on ClinicalTrials.gov, this trial (NCT01466127) looked at whether oxytocin — a hormone sometimes given as a nasal spray — had any effect on fear learning and fear reduction (extinction) in people. A total of 60 participants took part, split evenly into two groups of 30: one group received oxytocin and the other received a placebo (an inactive substance). By the end of the study, 16 people in the placebo group and 14 in the oxytocin group had completed the trial, meaning roughly half of each group did not finish. The main thing the researchers measured was something called skin conductance response (SCR) — a way of detecting small changes in sweat on the skin that can indicate an emotional or stress reaction. The reported data shows this was recorded during the first two "extinction trials," which are the early sessions where participants are exposed to a previously fear-linked cue without any negative outcome, as a way of measuring how fear begins to reduce. The SCR measurements were converted using a mathematical process (square root transformation) to make the data easier to analyse. The reported data shows the placebo group had an average score of 0.15 micro-Siemens (the unit used for skin conductance), while the oxytocin group had an average score of 0.00 micro-Siemens. No secondary outcome data appears to have been reported in the submitted results. It is worth noting that a large number of participants — around half in each group — did not complete the trial, which the reported data does not explain further. No reasons for non-completion were provided in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00709735 · results posted 10 April 2017

    According to the results reported on ClinicalTrials.gov, this trial involved two groups of participants — 11 people in the Non-Reactivation Propranolol group and 12 people in the Reactivation Propranolol group, for a total of 23 participants. The trial was measuring body-based stress responses (such as heart rate, sweat response, and facial muscle activity) while participants recalled traumatic memories, to estimate the likelihood of each person meeting criteria for Post-Traumatic Stress Disorder (PTSD). It also tracked self-reported PTSD symptom scores using a questionnaire called the Impact of Event Scale-Revised (IES-R), where scores can range from 0 to 88 and lower scores reflect fewer reported symptoms. The reported data shows that, for the main (primary) outcome — the estimated probability of being classified as having PTSD based on those body-based responses — the Non-Reactivation Propranolol group had a reported figure of 32%, while the Reactivation Propranolol group had a reported figure of 45%. For the secondary outcome, the questionnaire scores at the starting point were reported as 43.3 for the Non-Reactivation group and 45.0 for the Reactivation group. The reported change in scores over the study period showed the Non-Reactivation group's average score decreased by 8.2 points (suggesting fewer self-reported symptoms at the later time point), while the Reactivation group's average score increased by 4.5 points (suggesting more self-reported symptoms at the later time point). No further breakdown of these figures was reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00158262 · results posted 10 April 2017

    According to the results reported on ClinicalTrials.gov, this trial enrolled 43 people in total — 21 received a placebo (an inactive pill) and 22 received propranolol (a type of medication). All but one person in each group completed the study. The trial was looking at whether taking propranolol shortly after a traumatic event might be linked to differences in the body's stress responses when people later recalled that event in a structured setting. Researchers also tracked the overall severity of post-traumatic stress disorder (PTSD) symptoms using a standard clinician-rated questionnaire. The reported data shows that the main measurement was a calculated "probability score" — a percentage estimate of how likely a person's physical responses (such as heart rate, sweat response, and facial muscle activity during guided recall of their trauma) resembled those of people known to have PTSD. At the one-month mark, the placebo group had an average probability score of 40.7%, while the propranolol group had an average of 33.7%. At the three-month mark, those figures were 34.9% for the placebo group and 32.0% for the propranolol group. For the secondary measure — a clinician-rated symptom severity questionnaire scored from 0 (no symptoms) to 136 (most severe) — both groups started with an average score of 28.5. The reported data shows the placebo group's average score later measured 19.0, and the propranolol group's average score measured 21.2, though the specific time point for these follow-up scores was not clearly distinguished in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02139137 · results posted 7 March 2017

    According to the results reported on ClinicalTrials.gov, this trial involved two groups of participants — 22 people in what was called the "High Interference Control Condition" and 20 people in the "Low Interference Control Condition," giving a total of 42 participants at the start. Of those, 15 and 10 people respectively completed the study. The trial was measuring changes in PTSD symptoms (post-traumatic stress disorder symptoms), depression, anxiety, and day-to-day functioning in people across these two different conditions. The reported data shows that for the primary outcome — a clinician-rated measure of PTSD re-experiencing symptoms (scored on a scale of 0 to 40, where higher numbers mean more severe symptoms) — the estimated post-treatment score was 11.78 for the High Interference group and 15.69 for the Low Interference group. For a secondary measure looking at how many participants showed a meaningful response on the overall PTSD scale, 11 out of the High Interference group and 6 out of the Low Interference group were reported as responders. The reported data also shows scores on a depression scale (0–63) changed by 6.8 points in the High Interference group and 4.6 points in the Low Interference group; on a general anxiety scale (20–80), changes of 6.1 and 3.0 points were reported respectively; and on a disability/functioning scale (0–30), changes of 3.2 and 1.7 points were reported for each group. These numbers represent model-estimated figures based on participants' starting symptom levels, as noted in the study's own description of how results were calculated. The trial did not report whether these differences between groups were considered statistically meaningful, so that information is not available here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01120067 · results posted 16 December 2016

    According to the results reported on ClinicalTrials.gov, this trial (NCT01120067) involved 23 people in total — 12 in an "Intensive Treatment" group and 11 in a "Treatment as Usual" group. The trial was measuring pain using a tool called the McGill Pain Questionnaire (MPQ), which asks people to choose words that best describe their pain across three areas: how the pain feels physically, how it affects emotions, and how severe it seems overall. Scores on this questionnaire range from 0 to 78, where a higher number means more significant pain being reported. The reported data shows that at the measurement point recorded, the Intensive Treatment group had an average MPQ score of 31.91, while the Treatment as Usual group had an average score of 30.83. These are the only outcome figures reported — no other outcome measures appear in the submitted results data. It is also worth noting that not everyone finished the trial: 5 people in the Intensive Treatment group and 1 person in the Treatment as Usual group did not complete it, meaning the final results were based on 7 and 10 participants respectively. The reported data does not include any additional secondary outcome measures, so no further numbers can be described here — that information was not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01090180 · results posted 25 November 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 62 people in total — 33 in the dexamethasone (a type of steroid medication) group and 29 in the placebo (dummy pill) group. The trial was measuring symptoms of PTSD (post-traumatic stress disorder) and depression across multiple time points. Not everyone finished the study: 22 people in the dexamethasone group and 21 in the placebo group completed it. The reported data shows that PTSD symptoms were measured using a 17-question self-report scale scored from 17 to 85, where higher numbers mean more severe symptoms. At the start, both groups had similar scores — around 55.8 for the dexamethasone group and 54.8 for the placebo group. Across the later time points recorded, the dexamethasone group's scores were reported as approximately 50.1, 45.5, and 58.6, while the placebo group's scores were approximately 51.6, 51.9, and 48.2. For depression symptoms, a separate 16-question scale (scored 0 to 27, with higher meaning more severe) was also used. Starting scores were around 13.6 and 12.9 for the dexamethasone and placebo groups respectively, with both groups showing broadly similar scores across the remaining time points (ranging roughly from 10 to 11 for each group). The reported data shows the numbers at each time point as described above, but no further detail about what those differences mean statistically was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01401101 · results posted 2 September 2016

    According to the results reported on ClinicalTrials.gov, this trial involved 404 participants in total — 206 in a group called "PTSD Care Management" (PCM) and 198 in a "Treatment-as-Usual" (TAU) group, which represented the standard care people would normally receive. The trial was measuring symptoms of PTSD (post-traumatic stress disorder) using a tool called the Clinician-Administered PTSD Scale, or CAPS. This scale runs from 0 to 136, where a higher number means more severe symptoms, based on a clinician's ratings across 17 symptom areas. By the end of the study, 184 participants in the PCM group and 171 in the TAU group had completed the trial. The reported data shows that at the start of the trial (baseline), both groups had very similar average CAPS scores — 71.1 for the PCM group and 71.0 for the TAU group, suggesting comparable symptom levels going in. At the 6-month point, the reported average scores had dropped to 47.8 (PCM) and 49.5 (TAU). At the final measurement point, the reported scores were 46.9 for the PCM group and 44.2 for the TAU group. The data was not reported in a way that breaks down what caused these changes or whether the differences between the two groups were considered meaningful by the researchers. It is worth noting that this summary only covers the primary outcome measure (PTSD symptom scores) as reported in the structured data submitted to ClinicalTrials.gov — no secondary outcome data was included in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00288860 · results posted 25 April 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 412 people in a "Telephone Monitoring" group and 425 people in a "Treatment-As-Usual" group — a total of 837 participants. All had recently been discharged from a PTSD (post-traumatic stress disorder) treatment programme. The trial was measuring whether telephone check-ins after discharge made any difference to four main things: aggressive behaviour, alcohol problems, drug problems, and PTSD symptoms, as well as whether participants were readmitted to a psychiatric hospital within 12 months. It also tracked depression levels and quality of life as secondary (additional) measures. The reported data shows the following scores at follow-up. For aggressive behaviour (measured on a scale of 0–6, where higher is worse), the telephone monitoring group scored 3.0 and the treatment-as-usual group scored 3.1. For alcohol problems (scale 0–1), both groups scored 0.15 and 0.17 respectively. For drug problems (scale 0–1), both groups scored 0.05 each. For PTSD symptoms (scale 17–85, higher meaning more symptoms), the telephone monitoring group scored 63.9 and the treatment-as-usual group scored 63.4. Regarding hospital readmission within 12 months, 45 people in the telephone monitoring group and 55 people in the treatment-as-usual group were reported as being readmitted to a psychiatric hospital. For the secondary measures, depression scores (scale 0–60) were 38.0 versus 38.4, and quality of life scores (scale 1–7, higher meaning better) were 3.3 in both groups. The reported data shows that the numbers across both groups were broadly similar on most measures, though the trial's own interpretation of what those differences mean is not detailed in the submitted results data. It is worth noting that a notable number of participants did not complete all follow-up surveys — for example, only around 257–281 people completed the 12-month survey out of over 800 who started — which the results data does not explain further. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01814332 · results posted 25 April 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 128 people in total — 63 received the investigational drug GSK561679 and 65 received a placebo (a dummy treatment with no active ingredient). The trial was measuring changes in PTSD symptom severity over six weeks, using a structured interview called the CAPS (Clinician-Administered PTSD Scale), which scores symptoms from 0 (no symptoms) to 136 (the most severe). It also looked at depression symptoms and how many participants experienced any unwanted health events during the study. The reported data shows that, after six weeks, the average CAPS score dropped by about 26 points in the GSK561679 group and by about 27 points in the placebo group — meaning both groups showed a similar reduction in reported PTSD symptom scores. For a secondary measure — how many people had their CAPS score cut by at least half — 14 out of 63 participants in the GSK561679 group reached that mark, compared with 18 out of 65 in the placebo group. On the depression scale (MADRS, scored 0–60 where higher means more severe), average scores fell by about 7.8 points in the GSK561679 group and about 6 points in the placebo group. Regarding unwanted health events, the reported data shows 55 participants in each group experienced at least one adverse event during the study period. It is worth noting that 16 participants in each group did not complete the trial, though the reasons were not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01430624 · results posted 13 April 2016

    According to the results reported on ClinicalTrials.gov, this trial enrolled 245 people across three groups — roughly 82 in each — who had experienced a sexual assault. The trial was measuring substance use across three groups: one that watched a video called PPRS, one that watched a video called PIRI, and one that received standard care. The groups were followed up at six weeks, three months, and six months after the assault. Of those who started, 154 people completed the trial (54 in the PPRS group, 48 in the PIRI group, and 52 in the standard care group). The reported data shows several things were measured. At six months, drug use was assessed using a standard questionnaire (scored 0–10, where higher means more problematic use); the PPRS group scored 1.97, the PIRI group scored 2.03, and the standard care group scored 1.18. Alcohol problem severity (scored 0–40, higher meaning greater severity) at six months came in at 7.21, 7.53, and 8.15 for the three groups respectively. For the number of alcoholic drinks consumed in the two weeks before each check-in, the reported figures across the three follow-up time points ranged from roughly 8 to 20 drinks per fortnight across the groups. Cigarette numbers over the prior two weeks ranged from around 43 to 118 across groups and time points. Marijuana use (number of days used in the prior fortnight) ranged from roughly 1 to 3 days across groups and time points. The number of participants reporting use of other illicit drugs (such as cocaine) in the prior fortnight was small across all groups and time points, generally between 0 and 6 people. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT02400710 · results posted 3 February 2016

    According to the results reported on ClinicalTrials.gov, this trial involved 20 people in total, split evenly into two groups of 10. One group used the PTSD Coach app with support from a clinician, while the other group used the app entirely on their own without clinician involvement. All 20 participants completed the study. The trial was looking at PTSD symptom levels after using the app, as well as whether participants went on to attend specialist PTSD care afterwards. The reported data shows that PTSD symptoms were measured using a checklist covering 17 symptoms, each rated on a scale of 1 to 5, giving a possible total score anywhere from 17 (least severe) to 85 (most severe). At the end of the study, the clinician-supported group had an average score of 40.0, while the self-managed group had an average score of 49.8. For the second measure — whether participants attended at least one session at a PTSD specialist clinic after the study — the reported data shows that 7 out of 10 people in the clinician-supported group did so, compared to 1 out of 10 in the self-managed group. It is worth noting that this was a very small trial with only 10 people in each group, so the numbers above reflect a limited snapshot. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00744055 · results posted 18 January 2016

    According to the results reported on ClinicalTrials.gov, this trial (NCT00744055) looked at a medication called prazosin compared to a placebo (a dummy pill with no active ingredient) in people who had both post-traumatic stress disorder (PTSD) and alcohol use issues. A total of 50 people were assigned to take prazosin and 46 were assigned to take the placebo. Of those, 43 people in the prazosin group and 32 in the placebo group completed the study. The trial was measuring two main things: the number of days participants drank alcohol, and the severity of their PTSD symptoms using a standardised rating tool called the CAPS-5 scale. The reported data shows that, on average, people in the prazosin group had approximately 11 drinking days, while those in the placebo group had approximately 9 drinking days during the follow-up period. For PTSD symptom severity, the CAPS-5 scale runs from 0 (few or no symptoms) up to above 80 (extreme symptoms) — the reported data shows that both groups scored very similarly, with the prazosin group averaging around 37.9 and the placebo group also averaging around 37.9, which falls in the "sub-threshold to mild" PTSD range on that scale. It is worth noting that no secondary outcome measure data was included in the structured results submitted to ClinicalTrials.gov, so only the two primary measures described above were reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01605799 · results posted 17 December 2015

    According to the results reported on ClinicalTrials.gov, this trial involved 33 people in total — 17 in the "IOK Treatment" group and 16 in a "Wait List Control Group" (a comparison group who waited rather than receiving the treatment straight away). By the end of the study, 15 people in each group had completed it, with 2 dropping out of the treatment group and 1 from the wait list group. The trial was measuring changes in two things: post-traumatic stress disorder (PTSD) symptoms, and broader psychological symptoms such as depression, anxiety, and hostility. The reported data shows that PTSD symptoms were tracked using a self-report questionnaire scored from 17 (fewest symptoms) to 85 (most symptoms). The treatment group's average score dropped by 7.33 points over the study period, while the wait list group's average score dropped by 2.13 points. For the broader psychological symptoms measure — scored from 0 (fewest symptoms) to 212 (most symptoms) — the reported data shows the treatment group's average score dropped by 17.73 points, while the wait list group's average score actually increased by 4.53 points. In both cases, a lower score represents fewer reported symptoms. It is worth noting that this was a small study with around 15–17 people per group, and the results represent group averages rather than individual experiences. The reported data shows the numbers as submitted by the trial sponsor, but does not explain the reasons behind any of the changes observed. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01035788 · results posted 16 December 2015

    According to the results reported on ClinicalTrials.gov, this trial involved 46 people in total, split evenly into two groups of 23. One group received a treatment called Mindfulness-Based Cognitive-Behavioural Conjoint Therapy, and the other received Cognitive Behavioural Conjoint Therapy with a focus on communication skills. Both approaches were being studied in people with post-traumatic stress disorder (PTSD). Of the 46 who started, 17 people in the first group and 9 people in the second group completed the trial — meaning a notable number of participants did not finish, particularly in the second group. The main thing being measured was PTSD symptom severity, using a structured interview called the Clinician-Administered PTSD Scale (CAPS). This tool scores symptoms on a scale from 0 to 136, where a higher number means more severe symptoms, and a score of 45 or above was used in this trial to confirm a PTSD diagnosis. The reported data shows that at the time of measurement, the average score was 45.5 for the mindfulness-based group and 46.2 for the communication skills group. No other outcome measures were included in the data submitted to ClinicalTrials.gov, so further details about other aspects of participants' experience were not reported in the structured results. It is worth noting that the trial did not report separate before-and-after scores in the structured data, so it is not possible from these figures alone to describe how scores may have changed over the course of the study. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01856673 · results posted 28 September 2015

    According to the results reported on ClinicalTrials.gov, this trial involved 521 adults across three groups. Participants were recruited from two Colombian cities — Buenaventura and Quibdó — and were people who had experienced trauma. The trial compared two group therapy approaches against a "standby" (waitlist) group: one called the Common Elements Treatment Approach (CETA, 175 people), one called Narrative Community Group Therapy (175 people), and a standby comparison group (171 people). The trial measured changes in mental health symptoms — specifically anxiety, depression, and post-traumatic stress — using two established questionnaires, where scores ranged from 0 ("never") to 3 ("all the time"), with higher scores indicating worse symptoms. The reported data shows that all three groups had lower symptom scores at the end of the trial compared to when they started (shown as negative numbers, meaning scores went down). For the primary measures of anxiety, depression, and post-traumatic stress, the CETA group's scores dropped by between 0.48 and 0.89 points across the different symptom types, the Narrative Therapy group's scores dropped by between 0.40 and 0.51 points, and the standby group's scores dropped by between 0.18 and 0.50 points. The reported data shows similar patterns for the secondary measures of overall mental health symptoms and day-to-day functioning, with the CETA group again showing the largest reported reductions, though all three groups showed some decrease in scores over time. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01506323 · results posted 2 September 2015

    According to the results reported on ClinicalTrials.gov, this trial involved 173 veterans with post-traumatic stress disorder (PTSD) — 89 were assigned to a programme called Mantram Repetition (MRP), which involves silently repeating a personally meaningful word or phrase, and 84 were assigned to Present Centred Therapy (PCT), a talking therapy focused on current day-to-day problems. The trial measured PTSD symptom severity, as well as sleep difficulties and depression, using standard questionnaire tools rated by clinicians and participants themselves. The reported data shows that on the main PTSD measure (scored 0–136, where higher means more severe), both groups started at similar levels — around 77 for MRP and 76 for PCT. After treatment, reported scores were approximately 52 for MRP and 62 for PCT, and at a later follow-up point, approximately 51 for MRP and 59 for PCT. Similar patterns were reported across the three symptom sub-scores covering flashbacks and re-experiencing, avoidance behaviours, and heightened alertness, with the MRP group's reported numbers ending somewhat lower across all three areas at both time points. For sleep difficulties (scored 0–28), the MRP group moved from around 18 to about 13, while the PCT group moved from around 16 to about 16. For depression (scored 0–27), MRP moved from roughly 15 to about 11, and PCT moved from roughly 15 to about 12. The reported data shows changes in scores across both groups over the course of the trial, as described above. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00632632 · results posted 27 August 2015

    According to the results reported on ClinicalTrials.gov, this trial involved 25 people in total — 13 who received a medication called D-Cycloserine (DCS) and 12 who received a placebo (a dummy treatment with no active ingredient). All 13 people in the DCS group completed the trial, while 9 of the 12 in the placebo group completed it. The trial was measuring symptoms of post-traumatic stress disorder (PTSD) using a standard clinical interview tool called the Clinician Administered PTSD Scale (CAPS), which gives a total score between 0 and 136, where a higher score means more severe symptoms. It also looked at rates of major depression remission (meaning depression that was no longer present). The reported data shows two sets of CAPS scores — likely representing different time points during the trial. In the first set of measurements, the DCS group recorded an average score of 32.38, compared to 42.17 for the placebo group. In the second set of measurements, the DCS group recorded an average score of 24.15, compared to 45.92 for the placebo group. The trial did not report details explaining what each time point represented, so further context was not available in the submitted data. For the secondary outcome measuring depression, the reported data shows that 78% of participants in the DCS group showed remission of major depression, compared to 60% in the placebo group. It is worth noting that this was a very small trial with just 25 participants, which means the numbers should be interpreted with caution. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00539279 · results posted 19 August 2015

    According to the results reported on ClinicalTrials.gov, this trial involved 87 participants in total — 41 assigned to Prolonged Exposure Therapy (PE), a type of talking therapy focused on processing traumatic memories, and 46 assigned to Relaxation Training (RT). The trial was measuring symptoms of post-traumatic stress disorder (PTSD), depression, anxiety, day-to-day functioning, negative thought patterns, and cognitive (thinking and memory) abilities. Participants were assessed at the start of the trial, after treatment ended, and again six months later. Not everyone completed all stages — by the six-month follow-up, 17 participants remained in the PE group and 22 in the RT group. The reported data shows the following average scores across the two groups at the start of treatment, after treatment, and at six months. For PTSD symptoms (scored 17–85, where 50 or above suggests significant symptoms), the PE group started at 57.46, then dropped to 47.00 after treatment, then rose again to 58.37 at six months; the RT group started at 59.98, dropped slightly to 58.06 after treatment, and was 58.31 at six months. For depression symptoms (scored 0–27), the PE group went from 12.13 to 10.88 to 13.12, while the RT group went from 15.12 to 14.80 to 13.92. For anxiety (scored 20–80), the PE group recorded 44.46, 42.64, and 43.72; the RT group recorded 41.67, 43.75, and 42.63. For negative thoughts after trauma (scored 7–231), the PE group averaged 3.14, 2.80, and 3.44; the RT group averaged 3.78, 3.72, and 3.84. For day-to-day functioning difficulties (scored 0–30, where higher means poorer functioning), the PE group recorded 18.15, 15.31, and 21.06; the RT group recorded 18.83, 18.77, and 17.71. For the thinking and memory deficit score, data was reported only at the start and after treatment — the PE group scored 0.32 and 0.35, and the RT group scored 0.42 and 0.40; six-month follow-up data for this measure was not reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01018992 · results posted 30 July 2015

    According to the results reported on ClinicalTrials.gov, this trial enrolled 128 people in total — 63 received an investigational drug called GSK561679 and 65 received a placebo (a dummy treatment with no active ingredient). The trial was looking at people with post-traumatic stress disorder (PTSD) and ran for six weeks. The main thing being measured was whether PTSD symptom severity — scored using a structured interview called the CAPS scale, which runs from 0 (no symptoms) to 136 (most severe symptoms) — changed over that period. The reported data shows that, on the CAPS scale, people in the GSK561679 group had an average reduction of about 26 points from their starting score, while people in the placebo group had an average reduction of about 27 points. The trial also looked at how many participants had their CAPS score drop by at least 50% — a pre-set marker the researchers used to count someone as a "responder." The reported data shows 14 out of 63 people in the GSK561679 group met that threshold, compared with 18 out of 65 in the placebo group. For depression symptoms (measured on a separate scale called MADRS, ranging from 0 to 60), the GSK561679 group showed an average reduction of about 7.8 points and the placebo group about 6 points. Regarding unwanted side effects, the reported data shows that 55 participants in each group experienced at least one adverse event over the six weeks; no further breakdown of those events was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00908882 · results posted 9 June 2015

    According to the results reported on ClinicalTrials.gov, this trial enrolled 178 veterans in total — 89 in each of two groups. One group received an enhanced version of a digital health monitoring program (called "Health Buddy") combined with motivational interviewing (a type of structured conversation aimed at encouraging behaviour change), while the other group received the usual version of the same digital health program without the extra conversations. The trial was measuring smoking-related behaviours, specifically whether participants tried to quit smoking, whether they reported not smoking for seven days in a row, and whether they moved closer to being ready to quit (as measured by a standard questionnaire called the Transtheoretical Model of Change). The reported data shows the following numbers across what appear to be two separate follow-up time points. For quit attempts (defined as stopping smoking for at least 24 hours): at the first time point, 34 participants in the enhanced group and 28 in the usual care group reported a quit attempt; at the second time point, 24 in the enhanced group and 31 in the usual care group reported one. For reporting seven days without smoking: 20 in the enhanced group and 22 in the usual care group at the first time point, and 21 versus 20 at the second time point. For moving closer to the "action" stage of readiness to quit: 36 in the enhanced group and 35 in the usual care group at one time point, and 22 versus 21 at another. Of the 178 who started, 61 in the enhanced group and 59 in the usual care group completed the study; the reasons for non-completion were not reported in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00701064 · results posted 29 April 2015

    According to the results reported on ClinicalTrials.gov, this trial involved 71 people in total — 35 in a bright light exposure group and 36 in a group using a negative ion generator (used here as a placebo, or inactive comparison). Of those, 31 and 32 people respectively completed the study, with 4 dropping out from each group. The trial was measuring changes in PTSD (post-traumatic stress disorder) symptom severity over time, using three different rating scales completed either by a clinician or by the participants themselves. The reported data shows the following numbers for the two main (primary) outcome measures. On the CAPS-2 scale — a clinician-rated measure of PTSD severity scored from 0 to 136, where a higher number means more severe symptoms — the bright light group showed an average decrease (improvement) of 20.10 points, while the negative ion group showed an average decrease of 8.84 points. On the CGI scale — a 7-point clinician rating of overall change, where 1 means "very much improved" and 7 means "very much worse" — the bright light group averaged 2.61 and the negative ion group averaged 3.16, both sitting between "much improved" and "minimally improved." For the secondary (additional) outcome, a self-rated PTSD checklist scored from 17 to 85, the bright light group reported an average decrease of 11.03 points from their starting score, compared to 6.25 points in the negative ion group. It is important to note that these are simply the numbers as submitted — they describe what was measured and recorded, not whether one approach is better or recommended for anyone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00821678 · results posted 23 April 2015

    According to the results reported on ClinicalTrials.gov, this trial involved 265 people — 133 in the telemedicine outreach group and 132 in the "treatment as usual" group. The trial was looking at a remote care approach (delivered by video or phone) for people with post-traumatic stress disorder (PTSD), compared to whatever care participants would normally receive. The main thing being measured was how much PTSD symptom severity changed over the course of the study, using a standard questionnaire scored from 0 to 51, where a higher number means more severe symptoms. The reported data shows that, on the primary measure of PTSD symptom severity, the telemedicine group's average score went down by 5.31 points, while the treatment-as-usual group's average score went down by 1.07 points — both starting from their respective baselines. On the secondary measures, the telemedicine group also showed slightly larger reductions in depression symptom scores (down 0.43 versus down 0.16 on a 0–4 scale) and alcohol use scores (down 0.36 versus down 0.17 on a 0–12 scale). For physical health status (scored 0–100, higher is better), the telemedicine group's average score went up slightly by 0.77 points, while the treatment-as-usual group's average score went down by 1.45 points. On quality-of-life (scored 0–1), both groups showed very small decreases. For satisfaction with care, rated on a scale of 0 to 10, the telemedicine group reported an average of 8.83, compared to 7.70 in the treatment-as-usual group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01532999 · results posted 8 April 2015

    According to the results reported on ClinicalTrials.gov, this trial compared two group-based programs for people with post-traumatic stress disorder (PTSD): one called Mindfulness Based Stress Reduction (MBSR) and another called Present Centred Group Therapy (PCGT). A total of 191 people started the trial — 96 in the MBSR group and 95 in the PCGT group. By the end, 65 people in the MBSR group and 77 in the PCGT group had completed it, meaning 31 and 18 people respectively did not finish. The reported data shows that the main thing being measured was change in PTSD symptom severity, using a clinician-led assessment tool scored from 0 to 136 (where a higher number means more severe symptoms). According to the results reported on ClinicalTrials.gov, the MBSR group's average score decreased by 22.4 points from their starting score, while the PCGT group's average score decreased by 15.9 points. A self-reported PTSD symptom checklist (scored 17–85) also showed decreases: an average drop of 8.6 points for MBSR and 6.7 points for PCGT. For depression symptoms (scored 0–27), average scores dropped by 3.2 points in the MBSR group and 1.6 points in the PCGT group. A mindfulness questionnaire (scored 39–195, where higher means more mindful) showed an average increase of 5.2 points for MBSR and 2.1 points for PCGT. Scores on two sub-sections of the PTSD assessment — one measuring re-experiencing symptoms and one measuring avoidance and emotional numbing — also showed decreases in both groups, with the MBSR group showing slightly larger average reductions in both cases. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00535223 · results posted 26 March 2015

    According to the results reported on ClinicalTrials.gov, this trial involved 81 people in total — 41 in a group called "Group Based Exposure Therapy" and 40 in a group called "Present Centred Group Therapy." Most participants finished the trial (37 and 39 respectively). The trial was measuring PTSD symptoms in people taking part in two different types of group therapy, using structured interviews and self-reported questionnaires completed at multiple points during the study. The reported data shows that the main measure used was a clinician-led interview called the CAPS, which scores PTSD symptoms on a scale from 0 (no symptoms) to 136 (most severe symptoms possible). At the start of the trial, the Group Based Exposure Therapy group scored an average of 82.4 and the Present Centred Group Therapy group scored 81.18 — both indicating significant symptom levels. By the later measurement points, the reported data shows the Group Based Exposure Therapy group's average scores moved to 71.73 and then 69.29, while the Present Centred Group Therapy group's scores moved to 75.43 and then 71.03. A secondary questionnaire — the PTCI, which measures thoughts and beliefs associated with PTSD on a scale of 36 to 252 — showed starting averages of 145.45 and 135.29 for the two groups respectively, with later reported scores of 130.07 and then 127.36 for the first group, and 139.58 and then 140.57 for the second group. The reported results do not include information about whether the differences between the two groups were considered meaningful in a statistical sense, so those figures have not been included here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01022203 · results posted 9 March 2015

    According to the results reported on ClinicalTrials.gov, this trial involved 114 participants in total — 58 in a group called "Structured Approach Therapy" and 56 in a group called "PTSD Family Education." The trial was measuring psychological wellbeing (specifically post-traumatic stress, or PTSD), relationship adjustment, and difficulties managing emotions, across three time points: before treatment, after treatment, and at a follow-up check. By the post-treatment assessment, 44 participants remained in the Structured Approach Therapy group and 42 in the PTSD Family Education group, with similar numbers completing the follow-up. The reported data shows that PTSD was measured in two ways: by a clinician using a scale of 0–133 (higher scores mean more severe PTSD), and by participants themselves using a scale of 17–85 (again, higher means more severe). Both groups started at similar clinician-rated scores (around 82.9 out of 133). At the post-treatment point, the Structured Approach Therapy group's clinician-rated score had dropped to around 48.3, while the PTSD Family Education group's score was around 72.6. At follow-up, these figures were approximately 44.6 and 71.9 respectively. For the self-rated measure, both groups again started similarly (around 60.8 out of 85), dropping to around 42.2 (Structured Approach Therapy) and 53.9 (PTSD Family Education) after treatment, and to around 39.5 and 51.8 at follow-up. The reported data shows that for relationship adjustment (measured on a scale of 0–151, where higher means better adjustment), the Structured Approach Therapy group started at about 93.3 and rose to 105.2 after treatment and 106.8 at follow-up, while the PTSD Family Education group remained relatively steady across all three points (around 101.8–102.0). For difficulties managing emotions (measured on a scale of 36–125, where higher means more difficulty), both groups started at around 106–107. The Structured Approach Therapy group's score dropped to approximately 88.7 after treatment and 87.3 at follow-up, while the PTSD Family Education group's score remained around 106 across all time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00108628 · results posted 18 February 2015

    According to the results reported on ClinicalTrials.gov, this trial enrolled 124 participants in total — 61 in a group receiving a therapy called Imagery Rehearsal Therapy (IRT) and 63 in a group receiving a program called Sleep and Nightmare Management. The trial was measuring things related to nightmares and sleep quality across multiple time points, in people who appeared to be experiencing nightmares and sleep difficulties, likely in the context of PTSD (a condition involving lasting distress after traumatic events). By the end of the study, 41 participants in the IRT group and 53 in the Sleep and Nightmare Management group completed all assessments. The reported data shows that, for the main (primary) outcomes, both groups started with roughly similar scores. For weekly nightmare frequency, the IRT group began at around 3.95 nightmares per week and the Sleep and Nightmare Management group at 3.88, with both groups reporting figures in the range of roughly 3.0–3.6 at later time points. For the number of nights per week with a nightmare, both groups started at around 3.0 nights and the figures at later time points ranged between approximately 2.6 and 3.1 across both groups. Sleep quality was measured using a standard questionnaire scored from 0 to 21 (higher meaning poorer sleep); both groups started with scores around 13, which remained in the range of roughly 11–13 across later time points for both groups. The reported data for the secondary outcomes shows that scores measuring PTSD-related sleep disturbances, the impact of nightmares on daily life, and overall PTSD symptom severity were broadly similar between the two groups at the start and across subsequent time points, with no dramatic shifts in either direction reported for either group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00136357 · results posted 16 February 2015

    According to the results reported on ClinicalTrials.gov, this trial involved 82 people in total — 41 in a group that received Mind-Body Skills training, and 41 in a "delayed intervention" group (meaning they were put on a waiting list and received the program later). The trial was measuring symptoms associated with post-traumatic stress disorder (PTSD) — that is, distressing mental and emotional responses that can follow traumatic experiences. Most participants finished the study: 38 out of 41 in the Mind-Body Skills group, and 39 out of 41 in the delayed intervention group. The reported data shows that PTSD symptoms were measured using a questionnaire called the Harvard Trauma Questionnaire, which asks 16 questions and gives an average score between 1 and 4 — where a higher number means more symptoms reported. According to the results reported on ClinicalTrials.gov, both groups started with an average score of 2.5. At a later measurement point, the Mind-Body Skills group's average score was reported as 2.0, while the delayed intervention group's score was 2.4. At the final measurement point, both groups were reported at 2.0 and 2.1 respectively. The data does not include labels specifying exactly when each of these measurement points occurred, so the precise timing is not reported here. The reported data shows changes in average scores across these time points for both groups, but no further detail — such as whether those changes were considered meaningful — was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01020981 · results posted 11 February 2015

    According to the results reported on ClinicalTrials.gov, this trial involved soldiers from two US Army National Guard units — 150 from the Michigan Army National Guard and 150 from the Indiana Army National Guard, giving a total of 300 participants. The trial was primarily measuring whether it was practical to survey National Guard soldiers by mail, checking what proportion would actually return a posted survey. It also measured two other things as secondary goals: the level of depressive symptoms and the level of PTSD (post-traumatic stress disorder) symptoms reported by those who responded. The reported data shows that 46% of Michigan soldiers and 51% of Indiana soldiers returned the mailed survey. It is worth noting that a sizeable number of participants did not complete the study — 84 from Michigan and 90 from Indiana. For depressive symptoms, soldiers used a standard questionnaire (scored from 0 to 63, where lower scores mean fewer symptoms and a score of 0–13 is considered the minimal range). The reported data shows average scores of 5.01 for Michigan soldiers and 4.81 for Indiana soldiers, both falling within the minimal range on that scale. For PTSD symptoms, a separate military questionnaire was used (scored from 17 to 85, where a score of 50 or above is considered a marker for possible combat-related PTSD). The reported data shows average scores of 31.61 for Michigan soldiers and 29.56 for Indiana soldiers. These numbers reflect the averages across those who responded to the survey, and individual results within each group would have varied. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00638885 · results posted 15 January 2015

    According to the results reported on ClinicalTrials.gov, this trial enrolled 142 participants, all of whom completed the study — meaning no one dropped out. The group was made up of Vietnam Veteran Twins. The trial was measuring memory using a well-known memory assessment tool called the Wechsler Memory Scale – Logical Memory, which tests how well a person can remember and retain information from a short story or similar material. The result is expressed as a "retention percentage" — roughly, how much of what was learned was still remembered after a delay. The reported data shows two retention percentage scores recorded for the group: 77% and 82%. These appear to represent two separate measurements (for example, taken at different time points or under different conditions), though the data as reported on ClinicalTrials.gov does not provide further detail explaining what each figure specifically corresponds to. No additional outcome measures — such as secondary outcomes — were included in the submitted results data. It is worth noting that this trial had only one group, so there was no comparison group reported. The numbers above simply describe what was measured within that single group of Vietnam Veteran Twins, and no comparison figures were reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00371644 · results posted 16 December 2014

    According to the results reported on ClinicalTrials.gov, this trial involved 129 participants who were assigned to one of two groups: one group received Cognitive Processing Therapy (CPT), with 72 people starting, and the other received Present Centred Therapy (PCT), with 57 people starting. By the end of the study, 44 people in each group had completed the trial. The trial was measuring PTSD (post-traumatic stress disorder) symptoms using a self-report questionnaire called the PTSD Checklist (PCL), which asks 17 questions and produces a total score between 17 and 85 — where a higher score indicates more severe PTSD symptoms. The reported data shows that at the start of the trial, both groups had very similar average PCL scores: 65.53 for the CPT group and 65.40 for the PCT group, suggesting both groups began with comparably high symptom levels. Across subsequent measurement points, the average scores reported for the CPT group were 51.39, 52.71, 54.98, and 50.52, while the average scores for the PCT group were 57.89, 59.35, 55.22, and 56.22. The reported data shows that scores in both groups were lower at later time points compared to the start, though the exact timing of each measurement beyond the baseline was not clearly specified in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00475241 · results posted 10 November 2014

    According to the results reported on ClinicalTrials.gov, this trial enrolled 36 people in total — 18 in a group receiving Prolonged Exposure therapy and 18 in a group receiving Present Centred Therapy, both of which are talking-based treatments for PTSD (post-traumatic stress disorder). The trial was measuring PTSD symptom severity and several related physical and psychological markers at the end of treatment. Not everyone finished the trial: 11 out of 18 people completed Prolonged Exposure, and 15 out of 18 completed Present Centred Therapy. The reported data shows that on the main measure — a clinician-rated scale of PTSD symptom severity scored from 0 to 136 (where higher means more severe) — the Prolonged Exposure group recorded an average score of 30.0 at the end of treatment, while the Present Centred Therapy group recorded an average of 53.6. For the secondary measures, the reported data shows a physical "startle response" to trauma-related cues (measured in microvolts, where a higher number means a stronger reaction) was 4.8 in the Prolonged Exposure group and 19.5 in the Present Centred Therapy group. A measure of the body's morning cortisol (a stress-related hormone) response showed 1.2 units in the Prolonged Exposure group and 0.5 in the Present Centred Therapy group. Finally, a self-reported scale measuring unhelpful thoughts related to trauma (scored 21–147, higher meaning more problematic thoughts) returned an average of 91.3 for Prolonged Exposure and 97.1 for Present Centred Therapy. It is important to note that these are end-of-treatment scores only — the data as submitted does not include starting scores for each group, so it is not possible from this data alone to describe how much change occurred from the beginning to the end of treatment for either group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00373698 · results posted 7 November 2014

    According to the results reported on ClinicalTrials.gov, this trial involved 195 people split into two groups: 96 people received what was called the "Three Component Model of Collaborative Care" (a structured care approach), and 99 people received "usual care" (standard treatment as it would normally be given). The trial was measuring PTSD symptom severity as its main focus, along with depression, and two measures of general wellbeing — one covering mental health and one covering physical health. Of the 96 people in the collaborative care group, 85 completed the study, while all 99 in the usual care group completed it. The 11 people who did not finish were all from the collaborative care group; the data does not report the reasons. The reported data shows that PTSD symptom severity, measured using a questionnaire called the Posttraumatic Diagnostic Scale (where higher numbers indicate more severe symptoms), started at 31.4 for the collaborative care group and 31.5 for the usual care group, and ended at 30.2 and 29.9 respectively — meaning both groups showed very similar scores at both time points. For depression (measured on a scale where higher scores suggest more symptoms), both groups also recorded very close numbers at the start (1.80 and 1.84) and end (1.81 and 1.83) of the study. The reported data shows similarly close results for the mental wellbeing score (33.9 and 33.8 at the start; 33.7 and 33.4 at the end) and the physical wellbeing score (43.8 and 43.7 at the start; 44.4 and 44.8 at the end) — with both groups tracking closely together across all measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00855816 · results posted 20 October 2014

    According to the results reported on ClinicalTrials.gov, this trial enrolled 80 people in total — 47 in a "Breathing Training" group and 33 in a "Treatment as Usual" group. The trial was looking at symptoms of PTSD (post-traumatic stress disorder), specifically a cluster of symptoms known as hyperarousal — things like being easily startled, having trouble sleeping, or feeling constantly on edge. These symptoms were measured using a structured clinical interview called the CAPS, where trained clinicians rate how often and how severely a person experiences five hyperarousal symptoms. The total score on this part of the scale can range from 0 to 40, with higher numbers meaning more severe symptoms. The reported data shows that not everyone who started the trial finished it — only 21 out of 47 people completed the Breathing Training program, and 12 out of 33 completed Treatment as Usual. For those who did complete the trial, the researchers measured how much each person's hyperarousal score changed from the start to the end of the study. A negative number means the score went down (i.e., fewer or less severe symptoms were reported at the end). The reported data shows that the Breathing Training group had an average change score of −1.20, while the Treatment as Usual group had an average change score of −6.27. Both groups showed a reduction in reported scores, with the Treatment as Usual group showing a larger reported reduction on average. It is worth noting that a large number of participants did not complete the trial in either group, which the reported data does not explain further. No other outcome measures were reported in the structured results submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT01271244 · results posted 7 October 2014

    According to the results reported on ClinicalTrials.gov, this trial (NCT01271244) enrolled two groups of participants: 18 people who had both post-traumatic stress disorder (PTSD) and depression, and 8 people who had major depression only. The trial was measuring two aspects of heart activity — how much the time between heartbeats varies (called heart rate variability), and how much the heart's electrical recovery time varies (called QT interval variability). These measures are used by researchers to look at how the nervous system influences the heart. Not everyone finished the study: 11 of the 18 people in the PTSD and depression group completed it, and 5 of the 8 people in the major depression group completed it. The reported data shows the following numbers for the two main measurements. For heart rate variability (reported on a mathematical scale called natural log, where higher numbers reflect greater variability between heartbeats), the PTSD and depression group recorded 6.31 ln(msec), while the major depression group recorded 5.48 ln(msec). For QT interval variability (reported as a log ratio, where the value is normally a negative number and a less negative number may reflect more variability), the PTSD and depression group recorded −1.82, and the major depression group recorded −1.32. It is worth noting that the data as submitted appears to include only one set of measurements per group rather than separate before-and-after figures, and no comparison between groups was reported in the structured data provided. It is important to note that the trial had a small number of participants, and the data as reported on ClinicalTrials.gov does not include results for several secondary timepoints or comparisons — meaning some information was not reported in the structured results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00680524 · results posted 26 September 2014

    According to the results reported on ClinicalTrials.gov, this trial (NCT00680524) involved 20 participants in a single study group. Of those, 17 people completed the trial and 3 did not finish. The trial was measuring how acceptable a particular intervention was to both the patients receiving it and the providers delivering it — in other words, how well people felt the program worked for them in a practical, day-to-day sense. The reported data shows that acceptability was measured using a 5-point scale, where 1 meant "poor" and 5 meant "excellent." Three separate ratings were recorded for the group. The reported average scores were 4.7, 3.8, and 3.8 out of 5. The trial results do not specify which particular components of the intervention each of these three scores relates to, so a more detailed breakdown is not available from the data as submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT00260195 · results posted 22 May 2014

    According to the results reported on ClinicalTrials.gov, this trial involved 76 children in total — 39 who took part in a school-based cognitive behavioural support group, and 37 who were placed on a waiting list as a comparison group. The trial was measuring changes in four areas over time: symptoms of post-traumatic stress (often called PTSD), symptoms of depression, behavioural problems as reported by parents, and behavioural problems as reported by teachers. All measurements used standardised questionnaires where higher scores indicate more symptoms or problems, and children were assessed at multiple time points. The reported data shows the following score patterns across the two groups. For PTSD symptoms (scored 0–51), the support group started at 17.46, then recorded 13.72, then 11.97 across the measurement points; the wait-list group started at 19.41, then 18.32, then 15.59. For depression symptoms (scored 0–52), the support group went from 13.87 to 11.77 to 12.21, while the wait-list group went from 14.32 to 14.92 to 12.91. For parent-reported behaviour problems (scored 0–40), the support group recorded 11.64, 9.72, then 8.41, compared to 12.46, 11.30, then 8.91 in the wait-list group. For teacher-reported behaviour problems (scored 0–40), the support group recorded 11.33, 10.28, then 10.47, while the wait-list group recorded 8.59, 9.30, then 9.19. No data was reported on ClinicalTrials.gov about whether any differences between the groups were considered statistically meaningful. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00120250 · results posted 12 February 2014

    According to the results reported on ClinicalTrials.gov, this trial involved 27 people in total — 13 started in a group that took eszopiclone (a sleep medication) first and then switched to a placebo (a dummy pill), while 14 started with the placebo first and then switched to eszopiclone. By the end, 12 people completed each group, with 3 people not finishing the trial across both groups. The trial was measuring PTSD symptoms and sleep quality in participants, using several standardised questionnaires and a daily sleep diary. The reported data shows the following results when comparing periods on eszopiclone versus placebo. On the Short PTSD Rating Interview (scored 0–32, where higher means worse symptoms), participants scored an average of 16.13 on eszopiclone compared to 19.88 on placebo. On the Pittsburgh Sleep Quality Index (scored 0–21, where higher means worse sleep), the reported averages were 8.30 on eszopiclone and 11.29 on placebo. For secondary measures, the reported data shows participants took an average of about 26 minutes to fall asleep on eszopiclone compared to about 56 minutes on placebo, and reported sleeping an average of 390 minutes (about 6.5 hours) on eszopiclone versus around 362 minutes (about 6 hours) on placebo. On the Clinician-Administered PTSD Scale (scored 0–136, where 80 or above represents extreme symptoms), average scores were reported as 53.92 on eszopiclone and 67.5 on placebo. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00601952 · results posted 4 February 2014

    According to the results reported on ClinicalTrials.gov, this trial involved 31 military participants who were divided into two groups: 14 people received a treatment called Attention Bias Modification (ABM), and 17 people received a comparison condition called Attention Control (ACC). The trial was measuring symptoms of Post-Traumatic Stress Disorder (PTSD) — a condition that can develop after traumatic experiences. PTSD symptoms were tracked using a standard 17-question survey called the PCL-M, where scores can range from 17 (lowest severity) to 85 (highest severity). Of the 31 who started, 29 completed the study — 2 participants in the ABM group did not finish, while all 17 in the ACC group did. The reported data shows that at the start of the trial, the ABM group had an average PCL-M score of 57.14, and the ACC group had an average score of 61.33. By the end of the trial, the reported average score for the ABM group was 52.21, and for the ACC group it was 53.78. In plain terms, both groups recorded lower average scores on the PTSD symptom survey by the end of the study compared to the beginning. No other outcome measures were reported in the structured data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗

  • NCT01510834 · results posted 4 July 2013

    According to the results reported on ClinicalTrials.gov, this trial enrolled 90 participants in total, all of whom were in a single group — there was no comparison group. Of the 90 who started, 57 completed the study, and 33 did not finish. The trial was measuring changes in four self-reported questionnaire scores between the start of the study and a three-month follow-up point. The questionnaires covered PTSD symptoms (using a military-specific checklist called the PCL-M), quality of life, perceived stress, and depression symptoms. The reported data shows the following average changes in scores across participants who completed the study. For PTSD symptoms (PCL-M, scored 17–85 where higher means more symptoms), the average score went down by about 6.8 points — the study notes that a drop of 10 or more points is generally considered a clinically meaningful improvement. For quality of life (QOLS, scored 16–112 where higher is better), the average score went up by about 7.1 points, which the study notes aligns with what previous research considered a meaningful gain. For perceived stress (PSS, scored 0–40 where higher means more stress), the average score fell by about 3.8 points. For depression symptoms (PHQ-8, scored 0–24 where higher means more symptoms), the average score fell by about 2.1 points — the study notes that a drop of 5 points is generally considered an adequate response. It is worth noting that because there was only one group and no control or comparison group, the reported data shows changes over time within that single group only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

  • NCT00723008 · results posted 22 March 2013

    According to the results reported on ClinicalTrials.gov, this trial looked at a device-based treatment called Cranial Electrotherapy Stimulation (CES), which delivers a very mild electrical current to the head. It enrolled a total of 20 military participants — 11 in the active treatment group and 9 in a "sham" (inactive device) group. Participants moved through several phases: an initial enrolment period, a four-week blinded phase (where participants did not know which device they had), and a four-week unblinded phase. By the end of the trial, only 4 people in the active group and 3 in the sham group completed all phases, meaning the numbers are very small. The trial measured six different outcomes using questionnaires and rating scales across the two groups at different time points. The reported data shows the following average scores. For PTSD symptoms (scored 17–85, higher meaning more severe), the active group went from 53.8 at the start to 48.8 mid-trial and 55.5 at the end; the sham group went from 56.7 to 50.4 and then 44.7. For depression symptoms (scored 0–60), the active group recorded 28.8, then 27.5, then 36.3; the sham group recorded 30.6, then 24.5, then 21.7. For mood and anxiety (scored 0–96), the active group recorded 50.2, 42.3, and 51.0; the sham group recorded 55.9, 50.3, and 41.0. For sleep disturbance (scored 0–147), the active group recorded 76.3, 80.6, and 67.8; the sham group recorded 90.8, 83.3, and 56.3. For pain rated before and after each daily session (0–10 scale), the active group averaged 3.7 before and 2.9 after; the sham group averaged 3.9 before and 2.8 after. For anxiety rated before and after each session (0–10 scale), the active group averaged 3.6 before and 2.6 after; the sham group averaged 3.3 before and 2.3 after. It is worth noting that the number of participants who completed the trial was very small — around 7 people across both groups — and no statistical analysis results were included in the data reported to ClinicalTrials.gov, so the figures above should be interpreted with that context in mind. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

    View reported results on ClinicalTrials.gov ↗ · Linked publication on PubMed ↗

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Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.