Back to resultsOnline Cognitive Behavioural Therapy for Substance Use Disorder: The Impact of Peer Support
Primary Purpose
Substance Use Disorders
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Online Cognitive Behavioural Therapy
Individual Peer Support
Group Peer Support
Sponsored by
About this trial
This is an interventional treatment trial for Substance Use Disorders focused on measuring Cognitive behavioral therapy, Online treatment, Peer support
Eligibility Criteria
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
Sites / Locations
- Campbell Family Mental Health Research InstituteRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Online Cogntivie Behavioural Therapy
Online Cognitive Behavioural Therapy Plus Individual Peer Support
Group Peer Support
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
Timeline Follow-Back
Frequency (days) of substance use over the past 30 days
Secondary Outcome Measures
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.
Program and Client Costs- Substance Abuse Treatment (PACC-SAT)
Healthcare costs
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.
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.
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.
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.
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.
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.
Substance Use Calendar (SUC)
This chart that will collect self-reports of alcohol and drug use and quantities of primary substance used.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05127733
First Posted
October 14, 2021
Last Updated
February 6, 2023
Sponsor
Centre for Addiction and Mental Health
Collaborators
Breaking Free Online (BFO), Community Addictions Peer Support Association (CAPSA)
1. Study Identification
Unique Protocol Identification Number
NCT05127733
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2021 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health
Collaborators
Breaking Free Online (BFO), Community Addictions Peer Support Association (CAPSA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Use Disorders
Keywords
Cognitive behavioral therapy, Online treatment, Peer support
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
225 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Online Cogntivie Behavioural Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Online Cognitive Behavioural Therapy Plus Individual Peer Support
Arm Type
Experimental
Arm Description
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.
Arm Title
Group Peer Support
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Online Cognitive Behavioural Therapy
Other Intervention Name(s)
Breaking Free Online (BFO)
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Individual Peer Support
Other Intervention Name(s)
BFO Peer Support
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Group Peer Support
Other Intervention Name(s)
All People All Pathways
Intervention Description
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.
Primary Outcome Measure Information:
Title
Timeline Follow-Back
Description
Frequency (days) of substance use over the past 30 days
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Qualitative Interview
Description
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.
Time Frame
10 months
Title
Program and Client Costs- Substance Abuse Treatment (PACC-SAT)
Description
Healthcare costs
Time Frame
7 days
Title
Severity of Dependence Scale
Description
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.
Time Frame
1 month
Title
Alcohol Use Disorder Identification Test
Description
Alcohol use and associated harms. The minimum possible score is 0 and the maximum is 40, with higher scores indicating more harmful alcohol use.
Time Frame
1 month
Title
Drug Use Disorders Identification Test
Description
Drug use and associated harms. The minimum possible score is 0 and the maximum is 44, with higher scores indicating more harmful drug use.
Time Frame
1 month
Title
Patient Health Questionaire-9
Description
Depression symptom severity. The minimum possible score is 0 and the maximum is 27, with higher scores indicating more severe depression.
Time Frame
14 Days
Title
Generalized Anxiety Disorder-7
Description
Generalized anxiety symptom severity. The minimum possible score is 0 and the maximum is 24, with higher scores indicating more severe anxiety.
Time Frame
14 days
Title
World Health Organization Quality of Life Assessment
Description
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.
Time Frame
4 weeks
Title
Substance Use Calendar (SUC)
Description
This chart that will collect self-reports of alcohol and drug use and quantities of primary substance used.
Time Frame
14 days
Title
Brief COPE Scale
Description
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.
Time Frame
Baseline, up to 8 weeks, and up to 6 months
Title
Adult Hope Scale
Description
Assessment of level of hope. The minimum possible score is 12 and the maximum is 96, with higher scores indicating higher levels of hope.
Time Frame
Baseline, up to 8 weeks, and up to 6 months
Title
Positive and Negative Affect Schedule - Expanded Form
Description
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.
Time Frame
30 days
Title
Contemplation Ladder
Description
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.
Time Frame
Baseline, up to 8 weeks, and up to 6 months
Title
Treatment Acceptability/Adherence Scale
Description
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.
Time Frame
Baseline, up to 8 weeks, and up to 6 months
Title
World Health Organization Disability Assessment Schedule 2.0
Description
Overall level of functioning. The minimum possible score is 0 and the maximum is 100, with higher scores indicating more disability.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lena C. Quilty, PhD
Phone
4165358501
Ext
34313
Email
Lena.Quilty@camh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lena C. Quilty, PhD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Campbell Family Mental Health Research Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J 1H1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lena C. Quilty, PhD
Phone
416-535-8501
Ext
34313
Email
Lena.Quilty@camh.ca
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.camh.ca/research
Description
Description Information about research at the Centre for Addiction and Mental
Learn more about this trial
Online Cognitive Behavioural Therapy for Substance Use Disorder: The Impact of Peer Support
We'll reach out to this number within 24 hrs