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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
225
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).
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.
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.
Campbell Family Mental Health Research Institute
Toronto, Ontario, Canada
RECRUITINGTimeline Follow-Back
Frequency (days) of substance use over the past 30 days
Time frame: 30 days
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.
Time frame: 10 months
Program and Client Costs- Substance Abuse Treatment (PACC-SAT)
Healthcare costs
Time frame: 7 days
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.
Time frame: 1 month
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.
Time frame: 1 month
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.
Time frame: 1 month
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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.
Time frame: 14 Days
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.
Time frame: 14 days
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.
Time frame: 4 weeks
Substance Use Calendar (SUC)
This chart that will collect self-reports of alcohol and drug use and quantities of primary substance used.
Time frame: 14 days
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.
Time frame: Baseline, up to 8 weeks, and up to 6 months
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.
Time frame: Baseline, up to 8 weeks, and up to 6 months
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.
Time frame: 30 days
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.
Time frame: Baseline, up to 8 weeks, and up to 6 months
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.
Time frame: Baseline, up to 8 weeks, and up to 6 months
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.
Time frame: 30 days