Clinical trial Recruiting at 1 site Interventional Ages 14 to 35

Digital DBT for Youth at Risk of Psychosis

Official title: Digital Dialectical Behavioural Therapy (d-DBT) for Youth at Clinical High Risk (CHR) for Psychosis: An Exploratory Multi-Methods Study

Run by Centre for Addiction and Mental Health · NCT06928935 · Data updated 2026-11-12

This study tests a self-guided digital DBT program to help young people aged 14–35 who are at clinical high risk for psychosis, comparing it to usual care over eight weeks.

More Clinical High Risk for Psychosis (CHR) trials

Quick facts

Study typeInterventional
Ages14 Years to 35 Years
SexAll
Enrollment60 (estimated)
SponsorCentre for Addiction and Mental Health
Academic / other
Locations1 site (Toronto, Ontario)
StatusRecruiting
StartedApril 28, 2026
Main results expectedJanuary 1, 2028
Study endsJanuary 1, 2028
Registry record updatedSeptember 9, 2026
Trial IDNCT06928935 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are individuals aged 14–35 who meet CHR criteria for a psychosis risk syndrome and consent to participate, without psychotic disorder or major developmental/intellectual disabilities.

Probably not a fit

Patients with active psychosis, severe intellectual disability, acute suicidality, or who are receiving other structured digital mental health interventions may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

The trial will randomize CHR youth to receive a digital DBT program or treatment as usual for eight weeks. It aims to assess how feasible and acceptable the digital intervention is, and to gather preliminary data on its effects on emotional regulation, mood symptoms, substance use, and functioning. The approach uses interactive, skill-building modules focused on emotional regulation, distress tolerance, mindfulness, and related areas. Primary outcomes focus on feasibility, acceptability, and usability, while secondary outcomes look at clinical symptoms and functioning to inform future larger trials.

Why it matters

Potential benefit: If successful, the digital DBT program could offer an accessible way to improve emotional regulation and reduce distress in CHR youth, potentially delaying or reducing progression of psychosis risk.

How similar studies have gone: Previous digital mental health approaches show promise, but this specific digital DBT in CHR youth is a novel/early-stage investigation.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

1. Be 14-35 years old.
2. Being competent and willing to consent to study participation.
3. Meets CHR criteria for a psychosis risk syndrome based on the Structured Interview for Psychosis Risk Syndromes (SIPS) within the past 3 years.

Exclusion Criteria:

1. Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of psychotic disorder (e.g., schizophrenia spectrum disorder, mood disorder with psychotic features)
2. Diagnosis of intellectual disability
3. Severe developmental disorder
4. Acute suicidality requiring immediate life-saving intervention (i.e., inpatient psychiatric care).
5. Receiving any additional psychotherapy interventions or structured digital mental health support during the study period.

Where it's running

  • Centre for Addiction and Mental Health
    Toronto, Ontario, Canada
    Recruiting

Study contacts

  • Principal investigator: M. Omair Husain, MBBS, MRCPsych — The Centre for Addiction and Mental Health (CAMH)
  • Study coordinator: M. Omair Husain, MBBS, MRCPsych
  • Email: omair.husain@camh.ca
  • Phone: 416-535-8501

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.