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

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ClinicalTrials.gov Identifier: NCT05127733
Recruitment Status : Recruiting
First Posted : November 19, 2021
Last Update Posted : November 19, 2021
Sponsor:
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  ICMJE October 14, 2021
First Posted Date  ICMJE November 19, 2021
Last Update Posted Date November 19, 2021
Actual Study Start Date  ICMJE October 25, 2021
Estimated Primary Completion Date July 28, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Online Cognitive Behavioural Therapy for Substance Use Disorder: The Impact of Peer Support
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Substance Use Disorders
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 9, 2021)
225
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 26, 2024
Estimated Primary Completion Date July 28, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lena C. Quilty, PhD 4165358501 ext 34313 Lena.Quilty@camh.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05127733
Other Study ID Numbers  ICMJE 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  ICMJE
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  ICMJE Centre for Addiction and Mental Health
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Breaking Free Online (BFO)
  • Community Addictions Peer Support Association (CAPSA)
Investigators  ICMJE
Principal Investigator: Lena C. Quilty, PhD Centre for Addiction and Mental Health
PRS Account Centre for Addiction and Mental Health
Verification Date November 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP