Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06928935 | NOT YET RECRUITING | Clinical High Risk for Psychosis (CHR)

Digital Dialectical Behavioural Therapy (d-DBT) for Youth at Clinical High Risk (CHR) for Psychosis
Sponsor:

Centre for Addiction and Mental Health

Information provided by (Responsible Party):

Hazin's Head

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.

Condition or disease

Clinical High Risk for Psychosis (CHR)

Intervention/treatment

d-DBT

Phase

NA

Detailed Description:

This study evaluates the feasibility, acceptability, and preliminary efficacy of digital Dialectical Behavior Therapy (d-DBT) for youth at Clinical High Risk (CHR) for psychosis. Given the limited availability of evidence-based digital interventions tailored to this group, this trial explores whether a digital DBT approach can address emotion dysregulation, mood symptoms, and functional impairments, which are common in CHR populations and may contribute to distress and progression of disease. Participants will be randomized to receive either d-DBT or treatment-as-usual (TAU). The intervention is designed to be self-directed, incorporating, interactive exercises, and skill-building modules targeting emotional regulation, distress tolerance, mindfulness, and substance use. Primary outcomes include measuring feasibility, acceptability, and usability. Secondary measures will evaluate preliminary clinical outcomes related to psychiatric symptoms, substance use, and functioning. Results will inform future adaptations, larger trials, and clinical applications.

Study Type : INTERVENTIONAL
Estimated Enrollment : 60 participants
Masking : SINGLE
Masking Description : Outcome assessments will be conducted by a blinded assessor.
Primary Purpose : TREATMENT
Official Title : Digital Dialectical Behavioural Therapy (d-DBT) for Youth at Clinical High Risk (CHR) for Psychosis: An Exploratory Multi-Methods Study
Actual Study Start Date : 2025-04-28
Estimated Primary Completion Date : 2028-01-01
Estimated Study Completion Date : 2028-01-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 16 Years to 29 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • 1. Be 16-29 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.
Digital Dialectical Behavioural Therapy (d-DBT) for Youth at Clinical High Risk (CHR) for Psychosis

Location Details

NCT06928935

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Canada, Ontario

Centre for Addiction and Mental Health

Toronto, Ontario, Canada, M6J1H4