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

Center for Addiction and Mental Health (CAMH)

Status: Not yet enrolling

Conditions: Clinical High Risk for Psychosis (CHR)

Treatments: Behavioral: d-DBT

Study type: Interventional

Funder types: Other

Identifiers

NCT06928935

2025/007

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 16 to 29 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Experimental

Experimental group

Description:

This arm will receive the d-DBT intervention.

Treatment:

Behavioral: d-DBT

Control (Treatment as Usual)

No Intervention group

Description:

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