A Dialectical Behavioral Therapy Digital Health Solution for Outpatients Seeking Support for Substance Use

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Feasibility, Acceptability, and Efficacy of a Dialectical Behavioral Therapy Digital Health Solution in the CAMH Rainbow/COMPASS Service

Conditions
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Alcohol Use Disorder, Substance Use Disorders

Intervention / Treatment
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* Behavioral: Dialectical behavioral therapy skills training (DBT-ST)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18-65 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate Treatment<br>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)<br>* 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.<br>* Other names: Pocket Skills;|
| Active Comparator: Waitlist and Delayed Treatment<br>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)<br>* 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.<br>* Other names: Pocket Skills;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dialectical behavior therapy, digital health