Substance Use Disorders
Conditions
Keywords
Cognitive behavioral therapy, Online treatment, Peer support
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.
Interventions
BEHAVIORALOnline 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).
BEHAVIORALIndividual 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.
BEHAVIORALGroup 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.
Sponsors
Centre for Addiction and Mental Health
Breaking Free Online (BFO)
Community Addictions Peer Support Association (CAPSA)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Timeline Follow-Back | 30 days | Frequency (days) of substance use over the past 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| Substance Use Calendar (SUC) | 14 days | This chart that will collect self-reports of alcohol and drug use and quantities of primary substance used. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATORLena C. Quilty, PhD
Centre for Addiction and Mental Health
Outcome results
None listed