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

NCT06928935 | Not Yet Recruiting

• 1 other identifier: 2025/007
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (5)

• Recruitment

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

  8 weeks

• Retention

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

  8 weeks

• Adherence

  Percentage of modules completed; higher percentages indicate greater adherence.

  8 weeks

• Client Satisfaction Questionnaire

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

  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.

  8 weeks

Secondary Outcomes (14)

• Structured Interview for Psychosis-risk Syndromes (SIPS)

  Baseline and 8 weeks

• PRIME-Revised (PRIME-R)

  Baseline and 8 weeks

• Borderline Symptom List (BSL-23)

  Baseline and 8 weeks

• Brief Difficulties in Emotion Regulation Scale (DERS-16)

  Baseline and 8 weeks

• State-Trait Anxiety Inventory (STAI)

  Baseline and 8 weeks

Study Arms (2)

Experimental

EXPERIMENTAL

This arm will receive the d-DBT intervention.

Behavioral: d-DBT

Control (Treatment as Usual)

NO INTERVENTION

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

Interventions

d-DBT BEHAVIORAL

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.

Experimental

Eligibility Criteria

• Age: 16 Years - 29 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre for Addiction and Mental Health: lead

Study Sites (1)

Centre for Addiction and Mental Health

Toronto, Ontario, M6J1H4, Canada

Location

Related Publications (13)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Linehan MM, Korslund KE, Harned MS, Gallop RJ, Lungu A, Neacsiu AD, McDavid J, Comtois KA, Murray-Gregory AM. Dialectical behavior therapy for high suicide risk in individuals with borderline personality disorder: a randomized clinical trial and component analysis. JAMA Psychiatry. 2015 May;72(5):475-82. doi: 10.1001/jamapsychiatry.2014.3039.

  PMID: 25806661 BACKGROUND

• Woods SW, Addington J, Cadenhead KS, Cannon TD, Cornblatt BA, Heinssen R, Perkins DO, Seidman LJ, Tsuang MT, Walker EF, McGlashan TH. Validity of the prodromal risk syndrome for first psychosis: findings from the North American Prodrome Longitudinal Study. Schizophr Bull. 2009 Sep;35(5):894-908. doi: 10.1093/schbul/sbp027. Epub 2009 Apr 21.

  PMID: 19386578 BACKGROUND

• Addington J, van der Gaag M. Psychosocial treatments for clinical high risk individuals. Schizophr Bull. 2015 Jan;41(1):22. doi: 10.1093/schbul/sbu140. Epub 2014 Oct 14. No abstract available.

  PMID: 25316912 BACKGROUND

• Fusar-Poli P, De Micheli A, Signorini L, Baldwin H, Salazar de Pablo G, McGuire P. Real-world long-term outcomes in individuals at clinical risk for psychosis: The case for extending duration of care. EClinicalMedicine. 2020 Oct 7;28:100578. doi: 10.1016/j.eclinm.2020.100578. eCollection 2020 Nov.

  PMID: 33294806 BACKGROUND

• Hedemann TL, Lu Y, Campitelli S, Hawke LD, Shen N, Saperia S, Jones BDM, Strudwick G, Wilks CR, Wang W, Solmi M, Grossman M, Husain MI, Kozloff N, Foussias G, Husain MO. Adaptation and evaluation of a digital dialectical behaviour therapy for youth at clinical high risk for psychosis: A protocol for a feasibility randomized controlled trial. PLoS One. 2025 Dec 23;20(12):e0339163. doi: 10.1371/journal.pone.0339163. eCollection 2025.

  PMID: 41433354 DERIVED

Study Officials

• M. Omair Husain, MBBS, MRCPsych

  The Centre for Addiction and Mental Health (CAMH)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

M. Omair Husain, MBBS, MRCPsych

CONTACT

416-535-8501; omair.husain@camh.ca

Thea Hedemann, MD, FRCPC

CONTACT

416-535-8501; thea.hedemann@camh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessments will be conducted by a blinded assessor.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinician Scientist, Psychiatrist, Associate Professor

Study Record Dates

• First Submitted: March 26, 2025
• First Posted: April 15, 2025
• Study Start: April 28, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

CA (1)