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

Alcohol Use Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05094440
• Other study ID #: 016/2021
• Status: Completed
• Phase: N/A
• Start date: November 8, 2021
• Est. completion date: May 31, 2023

Study information

• Verified date: September 2023
• Source: Centre for Addiction and Mental Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism
• Substance Use Disorders
• Substance-Related Disorders

Intervention

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.

Locations

Country	Name	City	State
Canada	Campbell Family Mental Health Research Institute	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health	University of Missouri, St. Louis

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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

External Links

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