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

NCT ID: NCT05127733

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

225 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-25

Study Completion Date

2025-06-30

Brief Summary

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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

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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.

Conditions

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Substance Use Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Online Cognitive Behavioural Therapy

Intervention Type 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).

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.

Group Type EXPERIMENTAL

Online Cognitive Behavioural Therapy

Intervention Type 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).

Individual Peer Support

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Group Peer Support

Intervention Type 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.

Interventions

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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).

Intervention Type 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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Breaking Free Online (BFO) BFO Peer Support All People All Pathways

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Breaking Free Online (BFO)

UNKNOWN

Sponsor Role collaborator

Community Addictions Peer Support Association (CAPSA)

UNKNOWN

Sponsor Role collaborator

Centre for Addiction and Mental Health

OTHER

Sponsor Role lead

Responsible Party

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Lena Quilty

Senior Scientist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lena C. Quilty, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre for Addiction and Mental Health

Locations

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Campbell Family Mental Health Research Institute

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Lena C. Quilty, PhD

Role: CONTACT

4165358501 ext. 34313

Facility Contacts

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Lena C. Quilty, PhD

Role: primary

416-535-8501 ext. 34313

References

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Quilty LC, Wardell JD, Garner G, Elison-Davies S, Davies G, Klekovkina E, Corman M, Alfonsi J, Crawford A, de Oliveira C, Weekes J. Peer support and online cognitive behavioural therapy for substance use concerns: protocol for a randomised controlled trial. BMJ Open. 2022 Dec 12;12(12):e064360. doi: 10.1136/bmjopen-2022-064360.

Reference Type DERIVED
PMID: 36523236 (View on PubMed)

Related Links

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http://www.camh.ca/research

Description Information about research at the Centre for Addiction and Mental

Other Identifiers

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031/2020

Identifier Type: -

Identifier Source: org_study_id

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