Online Cognitive Behavioural Therapy for Substance Use Disorder: The Impact of Peer Support

Substance Use Disorders Clinical Trial

Official title:

Online Cognitive Behavioural Therapy for Substance Use Disorder: The Impact of Peer Support

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05127733
• Other study ID #: 031/2020
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: February 2024
• Source: Centre for Addiction and Mental Health
• Contact: Lena C. Quilty, PhD
• Phone: 4165358501
• Email: Lena.Quilty[@]camh.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and cost-effectiveness of Breaking Free Online, in a comparison of outpatients seeking treatment for substance use disorder who receive standard care with group peer support, versus with access to Breaking Free Online, versus with access to Breaking Free Online and individual peer support.

Description:

A total of 225 outpatients receiving standard care for substance use disorder from the Centre for Addiction and Mental Health will be randomized to receive clinical monitoring (CM) with group peer support, Breaking Free Online only, or Breaking Free Online with individual peer support, in an eight-week trial with a six-month follow-up period. The primary outcome is substance use frequency; secondary outcomes include substance use problems, depression, anxiety, quality of life, treatment engagement, and cost-effectiveness.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: June 30, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 18 years of age and above

2. Fluency in English

3. Understanding and willingness to comply with study requirements & provide informed consent

4. Current substance use disorder

5. Have used alcohol or substances within the past 30 days

6. Registration with CAMH Addictions Program outpatient services

Exclusion Criteria:

1. Current psychosis or mania

2. Current psychiatric disorder requiring care more urgently than substance use, including acute intoxication or withdrawal requiring medical attention

3. Significant neurological disorder or physical illness likely to interfere with participants

4. Any known practical factors that would preclude participation (e.g., extended absences)

5. Inability to read at a sixth grade level

Related Conditions & MeSH terms

• Substance Use Disorders
• Substance-Related Disorders

Intervention

Behavioral:
• Online Cognitive Behavioural Therapy
Interactive program utilizing cognitive behavioural therapy principles that guides users through its components and provides feedback, which facilitates behavior change (i.e., reduction in alcohol or substance use).
• Individual Peer Support
Weekly meetings with a trained peer support worker who guides participants through the BFO platform, reviews the platform's content with them, and supports them in the creation of an action strategy based on the platform's suggestions.
• Group Peer Support
Meetings with a group of peers led by a trained peer support worker/volunteer which will offer the participants an opportunity to discuss their experiences in a supportive and open environment.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Centre for Addiction and Mental Health	Breaking Free Online (BFO), Community Addictions Peer Support Association (CAPSA)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timeline Follow-Back	Frequency (days) of substance use over the past 30 days	30 days
Secondary	Qualitative Interview	This interview will follow established principles of qualitative research and include questions specifically designed for this study. This interview will have a two-pronged focus including (1) barriers and facilitators to the implementation of online CBT and (2) a complementary ethnographic focus on "health work" patients engage in to understand the impact of online CBT and explore ways to optimally deliver support during the care journey. Thematic analysis of interview data will be undertaken to offer a summative description of how patients give meaning to their experience.	10 months
Secondary	Program and Client Costs- Substance Abuse Treatment (PACC-SAT)	Healthcare costs	7 days
Secondary	Severity of Dependence Scale	A self-report questionnaire assessing the severity of drug dependence. The minimum possible score is 0 and the maximum is 15, with higher scores indicating more severe dependence.	1 month
Secondary	Alcohol Use Disorder Identification Test	Alcohol use and associated harms. The minimum possible score is 0 and the maximum is 40, with higher scores indicating more harmful alcohol use.	1 month
Secondary	Drug Use Disorders Identification Test	Drug use and associated harms. The minimum possible score is 0 and the maximum is 44, with higher scores indicating more harmful drug use.	1 month
Secondary	Patient Health Questionaire-9	Depression symptom severity. The minimum possible score is 0 and the maximum is 27, with higher scores indicating more severe depression.	14 Days
Secondary	Generalized Anxiety Disorder-7	Generalized anxiety symptom severity. The minimum possible score is 0 and the maximum is 24, with higher scores indicating more severe anxiety.	14 days
Secondary	World Health Organization Quality of Life Assessment	Quality of life over four domains. Subscale scores are calculated for 4 domains (physical health, psychological, social relationships and environment) and for "overall" and "general health" quality of life. Subscale scores have a range of 0 to 100, with higher scores indicating greater quality of life.	4 weeks
Secondary	Substance Use Calendar (SUC)	This chart that will collect self-reports of alcohol and drug use and quantities of primary substance used.	14 days
Secondary	Brief COPE Scale	Frequency of use of different coping strategies in response to stressors. Each coping strategy is rated on a scale of 1 to 4, with higher scores indicating more use of the strategy.	Baseline, up to 8 weeks, and up to 6 months
Secondary	Adult Hope Scale	Assessment of level of hope. The minimum possible score is 12 and the maximum is 96, with higher scores indicating higher levels of hope.	Baseline, up to 8 weeks, and up to 6 months
Secondary	Positive and Negative Affect Schedule - Expanded Form	Positive and negative affect as well as additional specific affects. The minimum score for each emotion is 1 and the highest possible score for each emotion is 5, with higher scores indicating more intensity of that emotion. Composite scores are computed for general positive and general negative affect, with a minimum total score of 10 and a maximum total score of 50 for each type, with higher scores indicating higher presence of that type of affect. Additional specific affect total scores are also computed with higher scores indicating more presence of the affect.	30 days
Secondary	Contemplation Ladder	Assessment of participant perspectives about changing substance use. The minimum score is 1 and the highest possible score is 10, with higher scores indicating more change in substance use.	Baseline, up to 8 weeks, and up to 6 months
Secondary	Treatment Acceptability/Adherence Scale	Treatment acceptability and anticipated or actual adherence in response to a given treatment. The minimum possible score is 10 and the maximum is 70, with higher scores indicating more acceptability or adherence to the treatment.	Baseline, up to 8 weeks, and up to 6 months
Secondary	World Health Organization Disability Assessment Schedule 2.0	Overall level of functioning. The minimum possible score is 0 and the maximum is 100, with higher scores indicating more disability.	30 days

External Links

•   Description Information about research at the Centre for Addiction and Mental