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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Clinical High Risk for Psychosis (CHR)
• Intervention / Treatment: Behavioral: d-DBT

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 Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: M. Omair Husain, MBBS, MRCPsych; Phone Number: 36467 416-535-8501; Email: omair.husain@camh.ca
• Study Contact Backup: Name: Thea Hedemann, MD, FRCPC; Phone Number: 39357 416-535-8501; Email: thea.hedemann@camh.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M6J1H4
      • Centre for Addiction and Mental Health
      • Contact: Omair Husain, MBBS; Phone Number: 416-535-8501; Email: omair.husain@camh.ca
      • Contact: Thea Hedemann, MD, FRCPC; Phone Number: 416-535-8501; Email: thea.hedemann@camh.ca
      • Contact: Omair Husain, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; This arm will receive the d-DBT intervention.	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.
No Intervention: Control (Treatment as Usual); This arm will not receive the intervention. Participants continue with standard outpatient care, including routine healthcare provider appointments and medication management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 8 weeks
PRIME-Revised (PRIME-R)	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.	Baseline and 8 weeks
Borderline Symptom List (BSL-23)	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.	Baseline and 8 weeks
Brief Difficulties in Emotion Regulation Scale (DERS-16)	A 16-item Likert scale scored from 1-5; total scores range from 16-80, with higher scores indicating greater difficulties in emotion regulation.	Baseline and 8 weeks
State-Trait Anxiety Inventory (STAI)	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.	Baseline and 8 weeks
Calgary Depression Scale for Schizophrenia (CDSS)	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.	Baseline and 8 weeks
Global Functioning: Social and Role Scales	Two clinician-rated scales ranging from 1-10 each, assessing social and role functioning; higher scores indicate better overall functioning.	Baseline and 8 weeks
Connor-Davidson Resilience Scale (CD-RISC)	A 25-item Likert scale scored from 0-4; total scores range from 0-100, with higher scores indicating greater resilience.	Baseline and 8 weeks
Columbia-Suicide Severity Rating Scale (C-SSRS)	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.	Baseline and 8 weeks
MATRICS Consensus Cognitive Battery (MCCB)	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.	Baseline and 8 weeks
Timeline Follow Back (TLFB)	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.	Baseline and 8 weeks
Cannabis Use Disorders Identification Test-Revised (CUDIT-R)	An 8-item screening tool scored from 0-32; higher scores indicate increased risk or severity of cannabis use disorder.	Baseline and 8 weeks
Daily Sessions, Frequency, Age of Onset, and Quantity of Cannabis Use Inventory (DFAQ-CU)	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.	Baseline and 8 weeks
Adolescent Alcohol and Drug Involvement Scale (AADIS)	A brief screening tool scoring substance use involvement from 0-79; higher scores indicate greater severity of alcohol and drug involvement.	Baseline and 8 weeks

Collaborators and Investigators

• Sponsor: Centre for Addiction and Mental Health
• Investigators: Principal Investigator: M. Omair Husain, MBBS, MRCPsych, The Centre for Addiction and Mental Health (CAMH)

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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. Erratum In: Schizophr Bull. 2004;30(2):following 217.
• 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.
• 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.
• 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.
• 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. Erratum In: JAMA Psychiatry. 2015 Sep;72(9):951. doi: 10.1001/jamapsychiatry.2015.1480.
• 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.
• 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.
• 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.
• 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. Erratum In: EClinicalMedicine. 2021 Feb 04;32:100729. doi: 10.1016/j.eclinm.2021.100729.

Study record dates

Study Major Dates

• Study Start (Estimated): April 28, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: March 26, 2025
• First Submitted That Met QC Criteria: April 8, 2025
• First Posted (Actual): April 15, 2025

Study Record Updates

• Last Update Posted (Actual): April 15, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: digital mental health; emotional dysregulation; clinical high risk for psychosis; mental health intervention; digital therapy; dialectical behavioural therapy
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: 2025/007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data that support the findings of this study will be available on reasonable request from the principal investigator.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No