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

N/ANot Yet RecruitingNCT06928935

Centre for Addiction and Mental Health60 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Eligibility

Sex: ALLMin age: 16 YearsMax age: 29 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Recruitment

The percentage of participants enrolled in the study, with higher numbers indicating greater recruitment success.

Time frame: 8 weeks

Retention

The percentage of participants who remain enrolled by the end of the study, with higher numbers indicating better retention.

Time frame: 8 weeks

Adherence

Percentage of modules completed; higher percentages indicate greater adherence.

Time frame: 8 weeks

Client Satisfaction Questionnaire

A Likert scale from 1-4, total scores range from 8-32, with higher scores indicating greater satisfaction.

Time frame: 8 weeks

System Usability Scale

A 10-item Likert scale scored from 1-5; total scores range from 0-100, with higher scores indicating greater perceived usability.

Time frame: 8 weeks

Secondary Outcomes

Structured Interview for Psychosis-risk Syndromes (SIPS)

The Structured Interview for Prodromal Symptoms (SIPS) is a widely used structured interview for diagnosing a CHR syndrome for psychosis and cases of first episode psychosis. It contains a severity rating scale (the Scale Of Psychosis-risk Symptoms, or SOPS). It is a 6-point scale, with higher scores indicating higher severity.