Clinical trial NCT05127733: 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
Overall status: RECRUITING
Phase: NA
Conditions: Substance Use Disorders
Keywords: Cognitive behavioral therapy
Online treatment
Peer support
Lead sponsor: Centre for Addiction and Mental Health
Sponsor class: OTHER
Collaborators: name: Breaking Free Online (BFO)
name: Community Addictions Peer Support Association (CAPSA)
First posted: 2021-11-19
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Timeline Follow-Back
timeFrame: 30 days
Secondary outcomes:
measure: Qualitative Interview
timeFrame: 10 months
measure: Program and Client Costs- Substance Abuse Treatment (PACC-SAT)
timeFrame: 7 days
measure: Severity of Dependence Scale
timeFrame: 1 month
measure: Alcohol Use Disorder Identification Test
timeFrame: 1 month
measure: Drug Use Disorders Identification Test
timeFrame: 1 month
measure: Patient Health Questionaire-9
timeFrame: 14 Days
measure: Generalized Anxiety Disorder-7
timeFrame: 14 days
measure: World Health Organization Quality of Life Assessment
timeFrame: 4 weeks
measure: Substance Use Calendar (SUC)
timeFrame: 14 days
measure: Brief COPE Scale
timeFrame: Baseline, up to 8 weeks, and up to 6 months
measure: Adult Hope Scale
timeFrame: Baseline, up to 8 weeks, and up to 6 months
measure: Positive and Negative Affect Schedule - Expanded Form
timeFrame: 30 days
measure: Contemplation Ladder
timeFrame: Baseline, up to 8 weeks, and up to 6 months
measure: Treatment Acceptability/Adherence Scale
timeFrame: Baseline, up to 8 weeks, and up to 6 months
measure: World Health Organization Disability Assessment Schedule 2.0
timeFrame: 30 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Campbell Family Mental Health Research Institute
state: Ontario
Study officials:
affiliation: Centre for Addiction and Mental Health
name: Lena C. Quilty, PhD
role: PRINCIPAL_INVESTIGATOR
References: