Substance Use Disorders Clinical Trial
Official title:
Online Cognitive Behavioural Therapy for Substance Use Disorder: The Impact of Peer Support
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.
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Campbell Family Mental Health Research Institute | Toronto | Ontario |
Lead Sponsor | Collaborator |
---|---|
Centre for Addiction and Mental Health | Breaking Free Online (BFO), Community Addictions Peer Support Association (CAPSA) |
Canada,
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 |
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