A Dialectical Behavioral Therapy Digital Health Solution for Outpatients Seeking Support for Substance Use
Feasibility, Acceptability, and Efficacy of a Dialectical Behavioral Therapy Digital Health Solution in the CAMH Rainbow/COMPASS Service
1 other identifier
interventional
76
1 country
1
Brief Summary
The purpose of this study is to compare the feasibility, acceptability, and efficacy of a dialectical behavior therapy skills training webapp known as "Pocket Skills" in outpatients and community members seeking treatment for substance use, across those who receive immediate versus delayed access to the intervention (e.g., a waitlist control condition).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 14, 2021
CompletedFirst Posted
Study publicly available on registry
October 26, 2021
CompletedStudy Start
First participant enrolled
November 8, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2023
CompletedSeptember 15, 2023
September 1, 2023
1.6 years
October 14, 2021
September 13, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Severity of Dependence Scale
Level of dependence on most problematic substance over past 30 days. Minimum score: 0, maximum score 15. Higher scores mean worse outcome.
30 days
Secondary Outcomes (9)
Patient Health Questionnaire-9 (Depression Subscale; PHQ-9)
14 days
Generalized Anxiety Disorder-7 (GAD-7) Scale
14 days
Difficulties in Emotion Regulation Scale, Short Form (DERS-SF; Kaufmann et al., 2015)
30 days
WHO Disability Assessment Schedule Short Form (WHODAS 2.0)
30 days
Mindful Attention and Awareness Scale (MAAS)
30 days
- +4 more secondary outcomes
Other Outcomes (2)
Treatment Acceptability Questionnaire (TAQ; Hunsley, 1992)
8 weeks
Credibility/Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000)
30 days
Study Arms (2)
Immediate Treatment
EXPERIMENTALPocket Skills is a dialectical behavior therapy skills training (DBT-ST) webapp that includes video lessons, an interactive chatbot AI coach, and in-app exercises to practice DBT skills. The delivery of the app intervention will be primarily monitored for one month, but followed for up to 3 months, and will be supplemented with a walk through manual and links to DBT worksheets. The intervention will be delivered in conjunction with treatment as usual which includes standard psychosocial care (e.g., assessments, group, and individual programming) as part of the Addictions Program or greater community.
Waitlist and Delayed Treatment
ACTIVE COMPARATORWaitlist control whereby outpatients or members of the community will wait 1 month (4 weeks) to receive the intervention and then receive the Pocket Skills webapp for the subsequent 2 months (8 weeks). The waitlist period and subsequent intervention will be delivered in conjunction with treatment as usual which includes standard psychosocial care (e.g., assessments, group, and individual programming) as part of the Addictions Program.
Interventions
Pocket Skills is a dialectical behavior therapy skills training (DBT-ST) webapp that includes video lessons, an interactive chatbot AI coach, and in-app exercises to practice DBT skills. The delivery of the app will occur primarily over 1 month, followed by 2 months of follow-up, and will be supplemented with a walk through manual and links to DBT worksheets.
Eligibility Criteria
You may qualify if:
- years of age
- Fluency in English
- Understanding and willingness to comply with study requirements
- Referred to Addictions Program at CAMH or seeking treatment from the community and currently waiting for psychosocial services
- Smartphone, tablet, or computer with access to the Internet
- Reports at least "contemplation" levels of wanting to reduce substance use
- Use of target substance in past month
- Alcohol or substance use disorder in the past year
You may not qualify if:
- Any known practical factor that would preclude participation (e.g., extended absences)
- Untreated or unstable severe psychiatric or medical disorder that precludes participation in the study (e.g., acute suicidality, untreated psychosis)
- Participation in another treatment/intervention study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Campbell Family Mental Health Research Institute
Toronto, Ontario, M6J 1H1, Canada
Related Publications (1)
Daros AR, Guimond TH, Yager C, Palermo EH, Wilks CR, Quilty LC. Feasibility, Acceptability, and Potential Efficacy of a Self-Guided Internet-Delivered Dialectical Behavior Therapy Intervention for Substance Use Disorders: Randomized Controlled Trial. JMIR Ment Health. 2024 Jan 16;11:e50399. doi: 10.2196/50399.
PMID: 38227362DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lena C. Quilty, Ph.D.
Campbell Family Mental Health Research Institute, CAMH
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Scientist
Study Record Dates
First Submitted
October 14, 2021
First Posted
October 26, 2021
Study Start
November 8, 2021
Primary Completion
May 31, 2023
Study Completion
May 31, 2023
Last Updated
September 15, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share