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

Not Applicable

Recruiting

• Conditions: Substance Use Disorders
• Interventions: Behavioral: Online Cognitive Behavioural Therapy; Behavioral: Group Peer Support; Behavioral: Individual Peer Support

• Registration Number: NCT05127733
• Lead Sponsor: Centre for Addiction and Mental Health

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-10-14
• Study Start: 2021-10-25
• Study First Submitted QC: 2021-11-09
• Study First Posted: 2021-11-19
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-17
• Last Update Posted: 2024-02-20
• Primary Completion: 2025-03-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 225

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Online Cognitive Behavioural Therapy Plus Individual Peer Support	Individual Peer Support	BFO delivered with peer support will comprise BFO with at least weekly contact with a peer with lived experience. Peer support workers will receive training on how to facilitate participant engagement with and progress through the BFO program, as well as a weekly session plan. As part of this training, peer support workers will be given their own access code to use BFO and be encouraged to use the program. Session One constitutes an initial orienting to the program. Subsequent sessions review each information and action strategy in the BFO program, with a series of prompts to guide peer support of this content. All groups will receive 'clinical monitoring,' including biweekly study assessments during the acute treatment period and monthly assessments during the six month follow-up period.
Online Cogntivie Behavioural Therapy	Online Cognitive Behavioural Therapy	Breaking Free Online (BFO) is an online intervention, supporting adults struggling with substance use. It provides psychoeducation and skills building exercises in CBT and compatible approaches. The intervention strategies contained within BFO are provided via a six-domain biopsychosocial model used in CBT. Each domain of the model corresponds to a module in the BFO program which contains psychoeducation and an 'action' strategy to facilitate behaviour change. Data captured at the baseline assessment is used by the program to provide feedback to the individual on their levels of functioning across the six domains. The program then guides the user to concentrate on intervention strategies for domains with the greatest level of impairment. All groups will receive 'clinical monitoring,' including biweekly study assessments during the acute treatment period and monthly assessments during the six month follow-up period.
Online Cognitive Behavioural Therapy Plus Individual Peer Support	Online Cognitive Behavioural Therapy	BFO delivered with peer support will comprise BFO with at least weekly contact with a peer with lived experience. Peer support workers will receive training on how to facilitate participant engagement with and progress through the BFO program, as well as a weekly session plan. As part of this training, peer support workers will be given their own access code to use BFO and be encouraged to use the program. Session One constitutes an initial orienting to the program. Subsequent sessions review each information and action strategy in the BFO program, with a series of prompts to guide peer support of this content. All groups will receive 'clinical monitoring,' including biweekly study assessments during the acute treatment period and monthly assessments during the six month follow-up period.
Group Peer Support	Group Peer Support	The control condition will consist of group peer support facilitated by trained peers and offered through the Community Addictions Peer Support Association (CAPSA). The group meets weekly and will offer participants a space to share their experiences and receive support. All groups will receive 'clinical monitoring,' including biweekly study assessments during the acute treatment period and monthly assessments during the six month follow-up period.

Primary Outcome Measures

Name	Time	Method
Timeline Follow-Back	30 days	Frequency (days) of substance use over the past 30 days

Secondary Outcome Measures

Name	Time	Method
Qualitative Interview	10 months	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.
Program and Client Costs- Substance Abuse Treatment (PACC-SAT)	7 days	Healthcare costs
Treatment Acceptability/Adherence Scale	Baseline, up to 8 weeks, and up to 6 months	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.
Severity of Dependence Scale	1 month	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.
Drug Use Disorders Identification Test	1 month	Drug use and associated harms. The minimum possible score is 0 and the maximum is 44, with higher scores indicating more harmful drug use.
World Health Organization Quality of Life Assessment	4 weeks	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.
Contemplation Ladder	Baseline, up to 8 weeks, and up to 6 months	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.
World Health Organization Disability Assessment Schedule 2.0	30 days	Overall level of functioning. The minimum possible score is 0 and the maximum is 100, with higher scores indicating more disability.
Alcohol Use Disorder Identification Test	1 month	Alcohol use and associated harms. The minimum possible score is 0 and the maximum is 40, with higher scores indicating more harmful alcohol use.
Generalized Anxiety Disorder-7	14 days	Generalized anxiety symptom severity. The minimum possible score is 0 and the maximum is 24, with higher scores indicating more severe anxiety.
Brief COPE Scale	Baseline, up to 8 weeks, and up to 6 months	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.
Patient Health Questionaire-9	14 Days	Depression symptom severity. The minimum possible score is 0 and the maximum is 27, with higher scores indicating more severe depression.
Substance Use Calendar (SUC)	14 days	This chart that will collect self-reports of alcohol and drug use and quantities of primary substance used.
Adult Hope Scale	Baseline, up to 8 weeks, and up to 6 months	Assessment of level of hope. The minimum possible score is 12 and the maximum is 96, with higher scores indicating higher levels of hope.
Positive and Negative Affect Schedule - Expanded Form	30 days	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.

Trial Locations

Locations (1)

Campbell Family Mental Health Research Institute; 🇨🇦 Toronto, Ontario, Canada