Substance Use DisordersNCT05127733
Online Cognitive Behavioural Therapy for Substance Use Disorder: The Impact of Peer Support
A study testing Online Cognitive Behavioural Therapy, Individual Peer Support and Group Peer Support in people with Substance Use Disorders, run by Centre for Addiction and Mental Health at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Substance Use Disorders
- What is being tested?
- Online Cognitive Behavioural Therapy, Individual Peer Support and Group Peer Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 198 participants
- Where
- 1 siteCanada
- Study dates
- 25 Oct 2021to 19 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Campbell Family Mental Health Research Institute
Toronto, Ontario, M6J 1H1
About this study
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.
Read the 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.
- Conditions
- Substance Use Disorders
- Being tested
- Online Cognitive Behavioural Therapy, Individual Peer Support, Group Peer Support
- Keywords
- Cognitive behavioral therapy, Online treatment, Peer support
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Cognitive Behavioural TherapyBehavioural
Also called Breaking Free Online (BFO)
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 SupportBehavioural
Also called BFO 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.
Group Peer SupportBehavioural
Also called All People All Pathways
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Online Cognitive Behavioural Therapy; Behavioral: 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. Receives: Behavioral: Group Peer Support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Timeline Follow-Back
Frequency (days) of substance use over the past 30 days
Measured: 30 days
Secondary outcomes (15)
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.
Measured: 10 months
Program and Client Costs- Substance Abuse Treatment (PACC-SAT)
Healthcare costs
Measured: 7 days
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.
Measured: 1 month
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.
Measured: 1 month
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.
Measured: 1 month
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.
Measured: 14 Days
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.
Measured: 14 days
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.
Measured: 4 weeks
Substance Use Calendar (SUC)
This chart that will collect self-reports of alcohol and drug use and quantities of primary substance used.
Measured: 14 days
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.
Measured: Baseline, up to 8 weeks, and up to 6 months
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.
Measured: Baseline, up to 8 weeks, and up to 6 months
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.
Measured: 30 days
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.
Measured: Baseline, up to 8 weeks, and up to 6 months
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.
Measured: Baseline, up to 8 weeks, and up to 6 months
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.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start25 Oct 2021
- Primary completion19 Dec 2025
- Study completion19 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance Use DisordersStudies of the same condition, open and under way.
- More trials run by Centre for Addiction and Mental HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 198 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Addiction and Mental Health
- Sponsor type
- University, hospital or other
- Collaborators
- Breaking Free Online (BFO), Community Addictions Peer Support Association (CAPSA)
- Responsible party
- Principal investigator, Lena Quilty, Centre for Addiction and Mental Health
- Investigators
- Lena C. Quilty, PhD, Principal investigator, Centre for Addiction and Mental Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127733
- Sponsor's protocol ID
- 031/2020
- Status last verified
- Mar 2026
- First submitted
- 14 Oct 2021
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36523236
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Cognitive Behavioural Therapy for Substance Use Disorder: The Impact of Peer Support
- ClinicalTrials.gov ID
- NCT05127733
- Acronym / sponsor ID
- 031/2020
- Conditions
- Substance Use Disorders
- Keywords
- Cognitive behavioral therapy, Online treatment, Peer support
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 198 participants (actual)
- Lead sponsor
- Centre for Addiction and Mental HealthUniversity, hospital or other
- Collaborators
- Breaking Free Online (BFO), Community Addictions Peer Support Association (CAPSA)
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 19 Dec 2025 (actual)
- Study completion
- 19 Dec 2025 (actual)
- First posted
- 19 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Online Cogntivie Behavioural Therapy | Experimental | Behavioral: Online Cognitive Behavioural TherapyBreaking 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. |
| Online Cognitive Behavioural Therapy Plus Individual Peer Support | Experimental | Behavioral: Online Cognitive Behavioural Therapy, Behavioral: Individual Peer SupportBFO 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 Peer Support | Active comparator | Behavioral: Group Peer SupportThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Cognitive Behavioural TherapyAlso: Breaking Free Online (BFO)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). | Behavioural | Online Cognitive Behavioural Therapy Plus Individual Peer Support, Online Cogntivie Behavioural Therapy |
| Individual Peer SupportAlso: BFO Peer SupportWeekly 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. | Behavioural | Online Cognitive Behavioural Therapy Plus Individual Peer Support |
| Group Peer SupportAlso: All People All PathwaysMeetings 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. | Behavioural | Group Peer Support |
Primary outcome
Timeline Follow-Back
Time frame: 30 days
Frequency (days) of substance use over the past 30 days
15 secondary outcomes
Qualitative Interview
Time frame: 10 months
Program and Client Costs- Substance Abuse Treatment (PACC-SAT)
Time frame: 7 days
Severity of Dependence Scale
Time frame: 1 month
Alcohol Use Disorder Identification Test
Time frame: 1 month
Drug Use Disorders Identification Test
Time frame: 1 month
Patient Health Questionaire-9
Time frame: 14 Days
Generalized Anxiety Disorder-7
Time frame: 14 days
World Health Organization Quality of Life Assessment
Time frame: 4 weeks
Substance Use Calendar (SUC)
Time frame: 14 days
Brief COPE Scale
Time frame: Baseline, up to 8 weeks, and up to 6 months
Adult Hope Scale
Time frame: Baseline, up to 8 weeks, and up to 6 months
Positive and Negative Affect Schedule - Expanded Form
Time frame: 30 days
Contemplation Ladder
Time frame: Baseline, up to 8 weeks, and up to 6 months
Treatment Acceptability/Adherence Scale
Time frame: Baseline, up to 8 weeks, and up to 6 months
World Health Organization Disability Assessment Schedule 2.0
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
- Derived from this study: PubMed 36523236Quilty 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.
- Description Information about research at the Centre for Addiction and MentalLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lena C. Quilty, PhD principal investigator
Centre for Addiction and Mental Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Cognitive Behavioural Therapy, Individual Peer Support and Group Peer Support in people with Substance Use Disorders, run by Centre for Addiction and Mental Health at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timeline Follow-Back (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05127733, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.