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

No phase Interventional Clinical High Risk for Psychosis (CHR)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: d-DBT.
Who it may be relevant to
Registry conditions: Clinical High Risk for Psychosis (CHR). Basic parameters: 16 years — 29 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Digital Dialectical Behavioural Therapy (d-DBT) for Youth at Clinical High Risk (CHR) for Psychosis: An Exploratory Multi-Methods Study

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.

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.

Interventions

  • Behavioral d-DBT
    d-DBT is an 8-week self-led online intervention that teaches mindfulness, emotional regulation, distress tolerance, and interpersonal effectiveness skills. Participants receive weekly digital navigator check-ins.

Primary outcome measures

  • Recruitment [Time frame: 8 weeks]
  • Retention [Time frame: 8 weeks]
  • Adherence [Time frame: 8 weeks]
  • Client Satisfaction Questionnaire [Time frame: 8 weeks]
  • System Usability Scale [Time frame: 8 weeks]
Secondary outcome measures (12)
  • Structured Interview for Psychosis-risk Syndromes (SIPS) [Time frame: Baseline and 8 weeks]
  • PRIME-Revised (PRIME-R) [Time frame: Baseline and 8 weeks]
  • Borderline Symptom List (BSL-23) [Time frame: Baseline and 8 weeks]
  • Brief Difficulties in Emotion Regulation Scale (DERS-16) [Time frame: Baseline and 8 weeks]
  • State-Trait Anxiety Inventory (STAI) [Time frame: Baseline and 8 weeks]
  • Calgary Depression Scale for Schizophrenia (CDSS) [Time frame: Baseline and 8 weeks]
  • Global Functioning: Social and Role Scales [Time frame: Baseline and 8 weeks]
  • Connor-Davidson Resilience Scale (CD-RISC) [Time frame: Baseline and 8 weeks]
  • Columbia-Suicide Severity Rating Scale (C-SSRS) [Time frame: Baseline and 8 weeks]
  • MATRICS Consensus Cognitive Battery (MCCB) [Time frame: Baseline and 8 weeks]
  • Timeline Follow Back (TLFB) [Time frame: Baseline and 8 weeks]
  • Cannabis Use Disorders Identification Test-Revised (CUDIT-R) [Time frame: Baseline and 8 weeks]

Eligibility criteria

Inclusion criteria

  • Be 16-29 years old.
  • Being competent and willing to consent to study participation.
  • 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

  • Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosis of psychotic disorder (e.g., schizophrenia spectrum disorder, mood disorder with psychotic features)
  • Diagnosis of intellectual disability
  • Severe developmental disorder
  • Acute suicidality requiring immediate life-saving intervention (i.e., inpatient psychiatric care).
  • Receiving any additional psychotherapy interventions or structured digital mental health support during the study period.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • Centre for Addiction and Mental Health — Toronto

Publications

  • Lawlor C, Vitoratou S, Hepworth C, Jolley S. Self-reported emotion regulation difficulties in psychosis: Psychometric properties of the Difficulties in Emotion Regulation Scale (DERS-16). J Clin Psychol. 2021 Oct;77(10):2323-2340. doi: 10.1002/jclp.23164. Epub 2021 May 10. PMID 33971018
  • Adamson SJ, Kay-Lambkin FJ, Baker AL, Lewin TJ, Thornton L, Kelly BJ, Sellman JD. An improved brief measure of cannabis misuse: the Cannabis Use Disorders Identification Test-Revised (CUDIT-R). Drug Alcohol Depend. 2010 Jul 1;110(1-2):137-43. doi: 10.1016/j.drugalcdep.2010.02.017. Epub 2010 Mar 26. PMID 20347232
  • Robinson SM, Sobell LC, Sobell MB, Leo GI. Reliability of the Timeline Followback for cocaine, cannabis, and cigarette use. Psychol Addict Behav. 2014 Mar;28(1):154-62. doi: 10.1037/a0030992. Epub 2012 Dec 31. PMID 23276315
  • Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176/appi.ajp.2011.10111704. PMID 22193671
  • Connor KM, Davidson JR. Development of a new resilience scale: the Connor-Davidson Resilience Scale (CD-RISC). Depress Anxiety. 2003;18(2):76-82. doi: 10.1002/da.10113. PMID 12964174
  • Miller TJ, McGlashan TH, Rosen JL, Cadenhead K, Cannon T, Ventura J, McFarlane W, Perkins DO, Pearlson GD, Woods SW. Prodromal assessment with the structured interview for prodromal syndromes and the scale of prodromal symptoms: predictive validity, interrater reliability, and training to reliability. Schizophr Bull. 2003;29(4):703-15. doi: 10.1093/oxfordjournals.schbul.a007040. PMID 14989408
  • Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x. PMID 10259963
  • Neacsiu AD, Eberle JW, Kramer R, Wiesmann T, Linehan MM. Dialectical behavior therapy skills for transdiagnostic emotion dysregulation: a pilot randomized controlled trial. Behav Res Ther. 2014 Aug;59:40-51. doi: 10.1016/j.brat.2014.05.005. Epub 2014 May 27. PMID 24974307

Identifiers

NCT: NCT06928935 · 2025/007

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗