Clinical trial NCT06928935: Digital Dialectical Behavioural Therapy (d-DBT) for Youth at Clinical High Risk (CHR) for Psychosis
Official title: Digital Dialectical Behavioural Therapy (d-DBT) for Youth at Clinical High Risk (CHR) for Psychosis: An Exploratory Multi-Methods Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Clinical High Risk for Psychosis (CHR)
Keywords: digital therapy
dialectical behavioural therapy
emotional dysregulation
mental health intervention
digital mental health
clinical high risk for psychosis
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
First posted: 2025-04-15
Enrollment: 60
Sex: ALL
Minimum age (years): 16
Maximum age (years): 29
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Recruitment
timeFrame: 8 weeks
measure: Retention
timeFrame: 8 weeks
measure: Adherence
timeFrame: 8 weeks
measure: Client Satisfaction Questionnaire
timeFrame: 8 weeks
measure: System Usability Scale
timeFrame: 8 weeks
Secondary outcomes:
measure: Structured Interview for Psychosis-risk Syndromes (SIPS)
timeFrame: Baseline and 8 weeks
measure: PRIME-Revised (PRIME-R)
timeFrame: Baseline and 8 weeks
measure: Borderline Symptom List (BSL-23)
timeFrame: Baseline and 8 weeks
measure: Brief Difficulties in Emotion Regulation Scale (DERS-16)
timeFrame: Baseline and 8 weeks
measure: State-Trait Anxiety Inventory (STAI)
timeFrame: Baseline and 8 weeks
measure: Calgary Depression Scale for Schizophrenia (CDSS)
timeFrame: Baseline and 8 weeks
measure: Global Functioning: Social and Role Scales
timeFrame: Baseline and 8 weeks
measure: Connor-Davidson Resilience Scale (CD-RISC)
timeFrame: Baseline and 8 weeks
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Baseline and 8 weeks
measure: MATRICS Consensus Cognitive Battery (MCCB)
timeFrame: Baseline and 8 weeks
measure: Timeline Follow Back (TLFB)
timeFrame: Baseline and 8 weeks
measure: Cannabis Use Disorders Identification Test-Revised (CUDIT-R)
timeFrame: Baseline and 8 weeks
measure: Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory (DFAQ-CU)
timeFrame: Baseline and 8 weeks
measure: Adolescent Alcohol and Drug Involvement Scale (AADIS)
timeFrame: Baseline and 8 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Centre for Addiction and Mental Health
state: Ontario
Study officials:
affiliation: The Centre for Addiction and Mental Health (CAMH)
name: M. Omair Husain, MBBS, MRCPsych
role: PRINCIPAL_INVESTIGATOR
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