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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 14 Years to 35 Years |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Centre for Addiction and Mental Health Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Status | Recruiting |
| Started | April 28, 2026 |
| Main results expected | January 1, 2028 |
| Study ends | January 1, 2028 |
| Registry record updated | September 9, 2026 |
| Trial ID | NCT06928935 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.
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Accelerated Brain Stimulation for Young People at Risk of Psychosis
This study tests a five-day accelerated brain-stimulation treatment to see if it is safe and tolerable for young people at risk for psychosis and to explore biomarkers that might show whether it works.
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Recovery-oriented suicide prevention for young people at clinical high risk for psychosis
This program tests a peer-supported, clinician-led suicide prevention group for young people at clinical high risk for psychosis to see if it helps reduce suicidal thoughts and support recovery.
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Mindfulness group experiences for young people at high risk for or early in psychosis
This project tries to understand how group mindfulness sessions feel for French-speaking young people aged 15–30 who are at ultra‑high risk for psychosis or have had a first episode.
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Biomarker changes after MT1988 dosing in young people at high risk for psychosis
This will test whether two doses of MT1988 taken twice daily for 8 weeks change biomarker tests in 17–30-year-olds at high risk for psychosis compared with placebo.
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French version of the Schizophrenia Proneness Instrument for children and adolescents (SPI-CY)
This project will test the French SPI-CY to see if it reliably identifies French-speaking adolescents (ages 12–17) who are at high risk for developing psychosis.
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Cognitive training and enhanced treatment for youth at high risk of psychosis in Tunisia
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.