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

• ClinicalTrials.gov Identifier: NCT05127733
• Recruitment Status: Recruiting
• First Posted: November 19, 2021
• Last Update Posted: November 19, 2021
• Sponsor: Centre for Addiction and Mental Health
• Collaborators: Breaking Free Online (BFO); Community Addictions Peer Support Association (CAPSA)
• Information provided by (Responsible Party): Lena Quilty, Centre for Addiction and Mental Health

Tracking Information

• First Submitted Date: October 14, 2021
• First Posted Date: November 19, 2021
• Last Update Posted Date: November 19, 2021
• Actual Study Start Date: October 25, 2021
• Estimated Primary Completion Date: July 28, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 9, 2021)

Timeline Follow-Back [ Time Frame: 30 days ]

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

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: November 9, 2021)

• 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.
• Program and Client Costs- Substance Abuse Treatment (PACC-SAT) [ Time Frame: 7 days ]
  Healthcare costs
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Online Cognitive Behavioural Therapy for Substance Use Disorder: The Impact of Peer Support
• Official Title: Online Cognitive Behavioural Therapy for Substance Use Disorder: The Impact of 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Outcomes Assessor); Primary Purpose: Treatment
• Condition: Substance Use Disorders

Intervention

• Behavioral: Online 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).
  Other Name: Breaking Free Online (BFO)
• Behavioral: Individual 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.
  Other Name: BFO Peer Support
• Behavioral: Group 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.
  Other Name: All People All Pathways

Study Arms

• Experimental: Online Cogntivie 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.

  Intervention: Behavioral: Online Cognitive Behavioural Therapy
• Experimental: Online Cognitive Behavioural Therapy Plus 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.

  Interventions:

  • Behavioral: Online Cognitive Behavioural Therapy
  • Behavioral: Individual Peer Support
• Active Comparator: 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.

  Intervention: Behavioral: Group Peer Support

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: November 9, 2021): 225
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 26, 2024
• Estimated Primary Completion Date: July 28, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Lena C. Quilty, PhD; 4165358501 ext 34313; Lena.Quilty@camh.ca

• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT05127733
• Other Study ID Numbers: 031/2020
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Lena Quilty, Centre for Addiction and Mental Health
• Original Responsible Party: Same as current
• Current Study Sponsor: Centre for Addiction and Mental Health
• Original Study Sponsor: Same as current

Collaborators

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

Investigators

• Principal Investigator: Lena C. Quilty, PhD; Centre for Addiction and Mental Health

• PRS Account: Centre for Addiction and Mental Health
• Verification Date: November 2021