PTSD Trial, Recruiting NCT04959695 Sponsor: VA Office of Research and Development Condition: PTSD
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PTSD Trial, Recruiting

NCT04959695
Recruiting Not Applicable

Who may be able to join

AI generated eligibility 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

Who might be able to join this trial:

  • People who are veterans between the ages of 18 and 65
  • People who are enrolled in VA healthcare and whose treating VA providers consider them eligible for PTSD talk therapy through the VA
  • People who have a current PTSD diagnosis confirmed by a structured clinical assessment (called the CAPS-5), with a symptom severity score of 26 or higher
  • People who are fluent in English
  • People who are willing to take part in one-on-one PTSD therapy sessions, either in person or by video, and are willing to use a mobile device as part of the treatment

Who may not be able to join:

  • People whose medical records show a neurological condition serious enough to interfere with therapy or assessments — such as major neurocognitive disorder, severe neurological diseases like ALS, or a history of severe traumatic brain injury (note: milder neurological conditions may still be considered, pending a short memory and thinking test — confirm with trial site)
  • People who currently have thoughts or intent to end their life
  • People who have a behavioral safety flag recorded in their VA medical record (confirm with trial site)
  • People whose medical record lists a serious mental health condition known to involve psychotic symptoms, such as schizophrenia or a depressive disorder with psychotic features; self-reported signs of psychosis will also be assessed
  • People who are currently in an ongoing threatening or dangerous situation, such as domestic violence
  • People whose screening results indicate severe alcohol use disorder, based on a questionnaire score of 13 or higher for women or 15 or higher for men
  • People who have previously completed three or more sessions of the specific type of therapy used in this trial (called Prolonged Exposure, or PE) for PTSD
  • People who are currently receiving another form of PTSD-focused talk therapy that is recommended in the VA/DoD clinical guidelines for PTSD treatment
  • People who have a physical condition that prevents them from properly using a mobile device
  • People who have not been on a stable dose of psychiatric medications for at least six weeks before enrolling

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 19 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Greg M. Reger, PhD, VA Puget Sound Health Care System Seattle Division, Seattle, WA

Phone: (253) 583-1677

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
29 July 2022
Est. completion
30 June 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in Posttraumatic Stress Related Functioning Inventory (PRFI) from baseline to mid-treatment, post-treatment, 1-month post-treatment f/up, 4-month post-treatment f/up

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov