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

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).

Study Overview

• Status: Completed
• Conditions: Substance Use Disorders; Alcohol Use Disorder
• Intervention / Treatment: Behavioral: Dialectical behavioral therapy skills training (DBT-ST)

Detailed Description

Seventy adult outpatients and community members seeking treatment for substance use from the Centre for Addiction and Mental Health Addictions Program will be randomized to receive immediate or delayed (1 month) access to a web-based DBT skills training intervention called Pocket Skills in addition to standard care. Participants will complete interviews and questionnaires at baseline. Following baseline, participants complete questionnaires at months 1, 2, and 3 months. Measures will assess alcohol and drug consumption, substance use disorder symptoms, and other clinical features.

• Study Type: Interventional
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M6J 1H1
      • Campbell Family Mental Health Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 18-65 years of age
2. Fluency in English
3. Understanding and willingness to comply with study requirements
4. Referred to Addictions Program at CAMH or seeking treatment from the community and currently waiting for psychosocial services
5. Smartphone, tablet, or computer with access to the Internet
6. Reports at least "contemplation" levels of wanting to reduce substance use
7. Use of target substance in past month
8. Alcohol or substance use disorder in the past year

Exclusion Criteria:

1. Any known practical factor that would preclude participation (e.g., extended absences)
2. Untreated or unstable severe psychiatric or medical disorder that precludes participation in the study (e.g., acute suicidality, untreated psychosis)
3. Participation in another treatment/intervention study

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate Treatment; 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 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.	Behavioral: Dialectical behavioral therapy skills training (DBT-ST); 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.; Other Names: Pocket Skills
Active Comparator: Waitlist and Delayed Treatment; Waitlist 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.	Behavioral: Dialectical behavioral therapy skills training (DBT-ST); 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.; Other Names: Pocket Skills

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire-9 (Depression Subscale; PHQ-9)	Level of depressive symptoms over the past 14 days. Minimum score: 0, maximum score 27. Higher scores mean worse outcome.	14 days
Generalized Anxiety Disorder-7 (GAD-7) Scale	Level of generalized anxiety symptoms over the past 14 days. Minimum score: 0, maximum score 21. Higher scores mean worse outcome.	14 days
Difficulties in Emotion Regulation Scale, Short Form (DERS-SF; Kaufmann et al., 2015)	Level of emotion dysregulation or the difficulty in changing unwanted emotions effectively in the past month. Minimum score: 18, maximum score 90. Higher scores mean worse outcome.	30 days
WHO Disability Assessment Schedule Short Form (WHODAS 2.0)	Level of functional disability in the past month. Minimum score: 0, maximum score 48. Higher scores mean worse outcome.	30 days
Mindful Attention and Awareness Scale (MAAS)	Measure of core mindfulness skills around awareness and acceptance, over the past month. Minimum score: 0, maximum score 6 (mean score on 15 items). Higher scores indicate more positive outcome (e.g., more mindful awareness).	30 days
Suicidal Behaviors Questionnaire, Revised (SBQ-R; Osman et al., 2001)	Measure of suicidal ideation and behaviors over the past month. Minimum score: 3, maximum score: 18. Higher scores indicate worse outcome.	30 days
Risky, Impulsive, and Self-Destructive Questionnaire (RISQ)	Measure of risky and impulsive behavior, past month. Only subscales pertaining to sexual behavior and general reckless behavior will be used. Minimum score: 0, Maximum score: 40. Higher scores indicate worse outcome (e.g., more impulsive and/or risky behaviors)	30 days
NIDA Assist	Assesses the frequency of non-alcohol substance use over the past month. Minimum score per item: never used substance; maximum score per item: used substance daily or almost daily. Higher scores indicate worse outcome (e.g., more substance use).	30 days
Daily Drinking Questionnaire (DDQ)	Assesses the frequency and quantity of alcohol use and binge drinking episodes over the past month. Minimum score: no alcoholic drinks on specific day; Maximum score: 15+ drinks on a specific day. Higher scores indicate worse outcome (E.g., more alcoholic drinks consumed).	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Acceptability Questionnaire (TAQ; Hunsley, 1992)	Whether or not the treatment is seen as acceptable and helpful with respect to current symptoms/problems. Minimum score: 6, maximum score: 42. Higher scores indicate better treatment acceptability and positive perceptions of the treatment.	8 weeks
Credibility/Expectancy Questionnaire (CEQ; Devilly & Borkovec, 2000)	Measure of treatment credibility and expectancy for interventions. Minimum score: 4; Maximum score: 56; Higher scores mean participants perceive the intervention to provide expected benefits and/or improvements.	30 days

Collaborators and Investigators

• Sponsor: Centre for Addiction and Mental Health
• Collaborators: University of Missouri, St. Louis
• Investigators: Principal Investigator: Lena C. Quilty, Ph.D., Campbell Family Mental Health Research Institute, CAMH

Publications and helpful links

Helpful Links

• Information about research at the Centre for Addiction and Mental Health
• Study webpage

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2021
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: October 14, 2021
• First Submitted That Met QC Criteria: October 14, 2021
• First Posted (Actual): October 26, 2021

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: dialectical behavior therapy, digital health
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Alcoholism
• Other Study ID Numbers: 016/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No