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Completed

NCT Number: NCT05127733

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.

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Key information

Conditions

Substance Use Disorders Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Campbell Family Mental Health Research Institute

Toronto, Ontario, M6J 1H1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years of age and above
  • Fluency in English
  • Understanding and willingness to comply with study requirements & provide informed consent
  • Current substance use disorder
  • Have used alcohol or substances within the past 30 days
  • Registration with CAMH Addictions Program outpatient services

Exclusion criteria

  • Current psychosis or mania
  • Current psychiatric disorder requiring care more urgently than substance use, including acute intoxication or withdrawal requiring medical attention
  • Significant neurological disorder or physical illness likely to interfere with participants
  • Any known practical factors that would preclude participation (e.g., extended absences)
  • Inability to read at a sixth grade level

Treatment and study plan

Online Cognitive Behavioural Therapy

Behavioral

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).

Other names: Breaking Free Online (BFO)

Individual Peer Support

Behavioral

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.

Other names: BFO Peer Support

Group Peer Support

Behavioral

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.

Other names: All People All Pathways

Primary outcomes

  1. Timeline Follow-Back

    Time frame: 30 days

    Frequency (days) of substance use over the past 30 days

Secondary outcomes

  1. Qualitative Interview

    Time frame: 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.

  2. Program and Client Costs- Substance Abuse Treatment (PACC-SAT)

    Time frame: 7 days

    Healthcare costs

  3. Severity of Dependence Scale

    Time frame: 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.

  4. Alcohol Use Disorder Identification Test

    Time frame: 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.

  5. Drug Use Disorders Identification Test

    Time frame: 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.

  6. Patient Health Questionaire-9

    Time frame: 14 Days

    Depression symptom severity. The minimum possible score is 0 and the maximum is 27, with higher scores indicating more severe depression.

  7. Generalized Anxiety Disorder-7

    Time frame: 14 days

    Generalized anxiety symptom severity. The minimum possible score is 0 and the maximum is 24, with higher scores indicating more severe anxiety.

  8. World Health Organization Quality of Life Assessment

    Time frame: 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.

  9. Substance Use Calendar (SUC)

    Time frame: 14 days

    This chart that will collect self-reports of alcohol and drug use and quantities of primary substance used.

  10. Brief COPE Scale

    Time frame: 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.

  11. Adult Hope Scale

    Time frame: 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.

  12. Positive and Negative Affect Schedule - Expanded Form

    Time frame: 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.

  13. Contemplation Ladder

    Time frame: 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.

  14. Treatment Acceptability/Adherence Scale

    Time frame: 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.

  15. World Health Organization Disability Assessment Schedule 2.0

    Time frame: 30 days

    Overall level of functioning. The minimum possible score is 0 and the maximum is 100, with higher scores indicating more disability.

Sponsors and collaborators

Lead sponsor

Centre for Addiction and Mental Health

Other

Collaborators

  • Breaking Free Online (BFO)
  • Community Addictions Peer Support Association (CAPSA)

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Nov 19, 2021
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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