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

Not Applicable

Not yet recruiting

• Conditions: Clinical High Risk for Psychosis (CHR)

• Registration Number: NCT06928935
• Lead Sponsor: Centre for Addiction and Mental Health

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.

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 Timeline

• Study First Submitted: 2025-03-26
• Status Verified: 2025-04
• Study First Submitted QC: 2025-04-08
• Last Update Submitted: 2025-04-08
• Study First Posted: 2025-04-15
• Last Update Posted: 2025-04-15
• Study Start: 2025-04-28
• Primary Completion: 2028-01-01
• Study Completion: 2028-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Recruitment	8 weeks	The percentage of participants enrolled in the study, with higher numbers indicating greater recruitment success.
Retention	8 weeks	The percentage of participants who remain enrolled by the end of the study, with higher numbers indicating better retention.
Adherence	8 weeks	Percentage of modules completed; higher percentages indicate greater adherence.
Client Satisfaction Questionnaire	8 weeks	A Likert scale from 1-4, total scores range from 8-32, with higher scores indicating greater satisfaction.
System Usability Scale	8 weeks	A 10-item Likert scale scored from 1-5; total scores range from 0-100, with higher scores indicating greater perceived usability.

Secondary Outcome Measures

Name	Time	Method
PRIME-Revised (PRIME-R)	Baseline and 8 weeks	A 12-item Likert scale (0-6) measuring severity of prodromal psychotic symptoms; total scores range from 0-72, with higher scores indicating greater symptom severity.
Borderline Symptom List (BSL-23)	Baseline and 8 weeks	A 23-item Likert scale scored from 0-4; total scores range from 0-92, with higher scores indicating greater severity of borderline personality symptoms.
Brief Difficulties in Emotion Regulation Scale (DERS-16)	Baseline and 8 weeks	A 16-item Likert scale scored from 1-5; total scores range from 16-80, with higher scores indicating greater difficulties in emotion regulation.
Connor-Davidson Resilience Scale (CD-RISC)	Baseline and 8 weeks	A 25-item Likert scale scored from 0-4; total scores range from 0-100, with higher scores indicating greater resilience.
Columbia-Suicide Severity Rating Scale (C-SSRS)	Baseline and 8 weeks	A structured clinical interview assessing suicidal ideation and behavior severity; scores include ideation severity (0-5) and behavior presence; higher scores indicate greater suicide risk.
MATRICS Consensus Cognitive Battery (MCCB)	Baseline and 8 weeks	A standardized cognitive assessment comprising 10 tests across 7 domains; total composite T-scores typically range from 10-90, with higher scores indicating better cognitive functioning.
Timeline Follow Back (TLFB)	Baseline and 8 weeks	A calendar-based assessment method recording daily cannabis, alcohol, and tobacco use over the past 7 days; higher frequency or quantity indicates greater substance use.
Cannabis Use Disorders Identification Test-Revised (CUDIT-R)	Baseline and 8 weeks	An 8-item screening tool scored from 0-32; higher scores indicate increased risk or severity of cannabis use disorder.
Adolescent Alcohol and Drug Involvement Scale (AADIS)	Baseline and 8 weeks	A brief screening tool scoring substance use involvement from 0-79; higher scores indicate greater severity of alcohol and drug involvement.
Structured Interview for Psychosis-risk Syndromes (SIPS)	Baseline and 8 weeks	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.
State-Trait Anxiety Inventory (STAI)	Baseline and 8 weeks	A 40-item measure (20 items for state anxiety, 20 items for trait anxiety) scored on a 4-point Likert scale (1-4); total scores range from 20-80 per subscale, with higher scores indicating greater anxiety.
Calgary Depression Scale for Schizophrenia (CDSS)	Baseline and 8 weeks	A 9-item clinician-rated scale scored from 0-3 per item; total scores range from 0-27, with higher scores indicating greater depressive symptom severity.
Global Functioning: Social and Role Scales	Baseline and 8 weeks	Two clinician-rated scales ranging from 1-10 each, assessing social and role functioning; higher scores indicate better overall functioning.
Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory (DFAQ-CU)	Baseline and 8 weeks	A self-report questionnaire assessing detailed patterns of cannabis use, including daily sessions, frequency, age of first use, and quantity consumed; higher values indicate greater cannabis involvement.

Trial Locations

Locations (1)

Centre for Addiction and Mental Health; 🇨🇦 Toronto, Ontario, Canada