Recruiting

d-DBT

Sponsor:

Centre for Addiction and Mental Health

Code:

NCT06928935

Conditions

Clinical High Risk for Psychosis (CHR)

Eligibility Criteria

Sex: All

Age: 14 - 35

Healthy Volunteers: Not accepted

Interventions

d-DBT

Study Details

Brief summary:

This study examines the feasibility and acceptability of a digital dialectical behavior therapy (d-DBT) intervention for youth at clinical high risk (CHR) for psychosis. The study aims to assess the acceptability of the intervention to the CHR population, the feasibility of conducting a larger-scale clinical efficacy trial and the potential benefits in improving emotional regulation, reducing psychiatric symptoms, and enhancing overall functioning. Participants will be randomized to receive either the d-DBT intervention or treatment as usual over eight weeks.

Conditions

Clinical High Risk for Psychosis (CHR)

Study ID

NCT06928935

Start date

Apr 28, 2026

Status verified date

Sep, 2026

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Jan 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 35

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental

This arm will receive the d-DBT intervention.

no intervention: Control (Treatment as Usual)

This arm will not receive the intervention. Participants continue with standard outpatient care, including routine healthcare provider appointments and medication management.

Interventions

d-DBT

d-DBT is an 8-week self-led online intervention that teaches mindfulness, emotional regulation, distress tolerance, and interpersonal effectiveness skills. Participants receive weekly digital navigator check-ins.

Primary outcome measure

  • Recruitment [ Time Frame: 8 weeks ]
  • Retention [ Time Frame: 8 weeks ]
  • Adherence [ Time Frame: 8 weeks ]
  • Client Satisfaction Questionnaire [ Time Frame: 8 weeks ]
  • System Usability Scale [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

M. Omair Husain, MBBS, MRCPsych

416-535-8501omair.husain@camh.ca

Thea Hedemann, MD, FRCPC

416-535-8501thea.hedemann@camh.ca

Locations

Centre for Addiction and Mental Health

Recruiting

Toronto, Ontario, Canada, M6J1H4

Contacts

Omair Husain, MBBS

416-535-8501omair.husain@camh.ca

Thea Hedemann, MD, FRCPC

416-535-8501thea.hedemann@camh.ca

Principal Investigator:

Omair Husain, MBBS

More Information

Sponsor

Centre for Addiction and Mental Health

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Keywords

  • digital therapy
  • dialectical behavioural therapy
  • emotional dysregulation
  • mental health intervention
  • digital mental health
  • clinical high risk for psychosis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre for Addiction and Mental Health on 2026-09-09.