Depression and Anxiety Trial, Not Yet Recruiting NCT07620340 Sponsor: PsyScale Condition: Depression and Anxiety
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Depression and Anxiety Trial, Not Yet Recruiting

NCT07620340
Not Yet Recruiting Not Applicable

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not 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 may be able to join

  • People who are seeking treatment primarily because of symptoms of Generalised Anxiety Disorder (GAD) and/or Major Depressive Disorder (MDD), as assessed by a Psychological Well-being Practitioner — a formal diagnosis is not required.
  • People whose symptom scores on a standard screening questionnaire fall within a specific range: a depression score (PHQ-9 or PHQ-A for younger people) of between 10 and 19, and/or an anxiety score (GAD-7) of between 8 and 21.
  • People aged between 16 and 64 years.
  • People who are taking medication for depression and/or anxiety and have been on a stable dose for at least 6 weeks before screening, with no changes to that medication during that time.
  • People who have reliable access to a compatible device with an internet connection and are able to use it for the screening process, the programme, and the assessments (any potential costs will be clearly explained in the participant information sheet).
  • People who have sufficient English language skills and the ability to engage with digital therapy content and complete questionnaires.
  • People who are willing to give informed consent to take part.
  • People who are willing to be randomly assigned to a group and to take part in a clinically supervised, artificial intelligence-based therapy programme built on CBT principles, including completing scheduled assessments.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People whose depression score (PHQ-9 or PHQ-A for younger people) is 20 or above.
  • People who have a current or past diagnosis of a condition that the investigator considers unsuitable for a digital CBT-based programme, including: post-traumatic stress disorder (PTSD) or complex trauma; psychotic disorder, bipolar disorder, or mania; complex or treatment-resistant obsessive-compulsive disorder (OCD); personality disorder; eating disorder; or a substance or alcohol use disorder.
  • People who are currently experiencing thoughts of suicide with a plan or intent to act on them (as shown by their questionnaire score and/or what they share with the team).
  • People who have made a suicide attempt in the past 12 months.
  • People who are currently engaged in ongoing self-harming behaviours.
  • People who need urgent or crisis mental health support (as shown by their questionnaire score and/or what they share with the team).
  • People aged 25 or under who are currently being treated with an antidepressant that was started or had its dose changed within the past 12 weeks (confirm with trial site for full details, as the source criteria appear incomplete).

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 22 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.

If you need support right now

This page includes language about suicide and self-harm, because that is how the trial's eligibility criteria are written. If reading it has been hard, you do not have to keep going. The services below are free, confidential, and answered by people trained for exactly this.

If you or someone else is in immediate danger, call 000.

  • Lifeline — 24/7 crisis support: 13 11 14
  • Suicide Call Back Service — 24/7 counselling: 1300 659 467
  • 13YARN — 24/7, for Aboriginal and Torres Strait Islander people: 13 92 76
  • Beyond Blue — 24/7 mental health support: 1300 22 4636
  • Kids Helpline — 24/7, free and private for anyone aged 5 to 25: 1800 55 1800
  • headspace — mental health support for 12 to 25 year olds: headspace.org.au
  • Emergency: 000

Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention. If you are in immediate danger, call your local emergency number.

Voxsanity is not a crisis service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.

GP referral letter

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

Trial details

Status
Not Yet Recruiting
Phase
Not Applicable
Sponsor
PsyScale
Registry
ClinicalTrials.gov
Start date
1 June 2026
Est. completion
9 September 2026

Primary endpoints

Patient Health Questionnaire - 9 items (PHQ-9); Patient Health Questionnaire - Adolescent (PHQ-A); Generalized Anxiety Disorder assessment (GAD-7)

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: 22 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