NCT05127733

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
198

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2021

Completed
11 days until next milestone

Study Start

First participant enrolled

October 25, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 19, 2021

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2025

Completed
Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

4.2 years

First QC Date

October 14, 2021

Last Update Submit

March 26, 2026

Conditions

Keywords

Cognitive behavioral therapyOnline treatmentPeer support

Outcome Measures

Primary Outcomes (1)

  • Timeline Follow-Back

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

    30 days

Secondary Outcomes (15)

  • Qualitative Interview

    10 months

  • Program and Client Costs- Substance Abuse Treatment (PACC-SAT)

    7 days

  • Severity of Dependence Scale

    1 month

  • Alcohol Use Disorder Identification Test

    1 month

  • Drug Use Disorders Identification Test

    1 month

  • +10 more secondary outcomes

Study Arms (3)

Online Cogntivie Behavioural Therapy

EXPERIMENTAL

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.

Behavioral: Online Cognitive Behavioural Therapy

Online Cognitive Behavioural Therapy Plus Individual Peer Support

EXPERIMENTAL

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.

Behavioral: Online Cognitive Behavioural TherapyBehavioral: Individual Peer Support

Group Peer Support

ACTIVE COMPARATOR

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.

Behavioral: Group Peer Support

Interventions

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).

Also known as: Breaking Free Online (BFO)
Online Cognitive Behavioural Therapy Plus Individual Peer SupportOnline Cogntivie Behavioural Therapy

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.

Also known as: BFO Peer Support
Online Cognitive Behavioural Therapy Plus Individual 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.

Also known as: All People All Pathways
Group Peer Support

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Campbell Family Mental Health Research Institute

Toronto, Ontario, M6J 1H1, Canada

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Lena C. Quilty, PhD

    Centre for Addiction and Mental Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Scientist

Study Record Dates

First Submitted

October 14, 2021

First Posted

November 19, 2021

Study Start

October 25, 2021

Primary Completion

December 19, 2025

Study Completion

December 19, 2025

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations