Substance Use Disorder (SUD)PROCESSNCT07342218
Correctional Service of Canada Pilot Trial of Digital Substance Use Disorder Interventions (PROCESS)
A study testing Breaking Free Online (BFO) and Computer-Based Training for Cognitive Behavioural Therapy (CBT4CBT) in people with Substance Use Disorder (SUD), run by St. Joseph's Healthcare Hamilton at 4 sites in Canada.
Trial summary
Problems with substance use are common in prisoners. Since most substances are still illegal in Canada, substance use problems can increase the risk for re-incarceration. Although research suggests that treatment may reduce these risks, they are still rarely used in correctional settings. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Substance Use Disorder (SUD)
- What is being tested?
- Breaking Free Online (BFO) and Computer-Based Training for Cognitive Behavioural Therapy (CBT4CBT)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesCanada
- Study dates
- 25 Feb 2026to Mar 2027
- Phase
- Interventional
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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individuals who have previously served custodial services in the Correctional Services of Canada (csc).
- Individuals who have a history of substance use problems (i.e., determined by them not being allowed to use substances as part their parole terms)
- Individuals who current reside in a Community Correctional Centre or Community-Based Residential Facility
- Individuals between 18-55 years old
Who cannot join
- Individuals who have never served a custodial sentence with the CSC
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada4 sites, 4 recruiting
- Recruiting
Salvation Army Booth Centre
Brantford, Ontario, N3T 2J6
Joshua Patenaude, 519-753-4193, joshua.patenaude@salvationarmy.ca
- Recruiting
The Salvation Army - Ellen Osler Home
Dundas, Ontario, L9H 2E8
Meagan Hardyman, (905) 627-1632, Meagan.Hardyman@salvationarmy.ca
- Recruiting
The St. Leonard's Society Of Hamilton
Hamilton, Ontario, L8L 2P2
Ryan Johnson, (905) 572-1150 EXT 332, ryanjohnson@slsh.ca
- Recruiting
St Leonard's Clinton House
Hamilton, Ontario, L8N 2V2
Colin Avery, 905-529-8494 ext. 327, cavery@slsh.ca
About this study
Official title: Pilot Trial of Digital Substance Use Disorder Interventions to Prevent Post-release Substance Use Disorder Relapse in Offenders in Correctional Service of Canada Custody
Problems with substance use are common in prisoners. Since most substances are still illegal in Canada, substance use problems can increase the risk for re-incarceration. Although research suggests that treatment may reduce these risks, they are still rarely used in correctional settings. This pilot study will examine the feasibility and usefulness of two digital treatments for substance use problems in individuals recently released from prison. The investigators will compare engagement across both treatments over a 6-month period, and assess the rates of substance use relapse and re-incarceration.
- Conditions
- Substance Use Disorder (SUD)
- Being tested
- Breaking Free Online (BFO), Computer-Based Training for Cognitive Behavioural Therapy (CBT4CBT)
- Keywords
- incarceration, federal offender, substance use disorder, cognitive behavioural therapy, mindfulness, digital treatment, substance use treatment, pilot trial
- 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.
Breaking Free Online (BFO)Other
BFO is a digital intervention for substance use problems and commonly co-occurring disorders, such as depression and anxiety. Its structure is based on cognitive behavioural therapy (CBT) and mindfulness techniques. It is self-directed by the individual and can be done on a smartphone, tablet, or online. BFO provides techniques for cognitive restructuring (i.e., reshaping how we view certain situations) and managing and planning for high-risk situations (e.g., minimizing relapse in the face of certain triggers).
Computer-Based Training for Cognitive Behavioural Therapy (CBT4CBT)Other
CBT4CBT is a digital intervention used for substance use problems through the application of CBT techniques. The program involves various video modules, educational games, quizzes, interactive videos, and more. The modules are self-paced and can be done online. Modules will focus on teaching users core skills to avoid substance use and ways of effectively communicating. It discusses various situations where potential triggers could arise, and homework done afterwards allows the user to identify their own personal triggers and individualize how they can minimize these risks.
| Study group | Role | What they receive |
|---|---|---|
| Computer-Based Training for Cognitive Behavioural Therapy | Experimental | Participants will complete a 7-module digital treatment intervention for substance use, using cognitive behavioural therapy practices. Receives: Other: Computer-Based Training for Cognitive Behavioural Therapy (CBT4CBT) |
| Breaking Free Online | Experimental | Participants will complete a 6-module digital treatment intervention for substance use, using cognitive behavioural therapy and mindfulness techniques. Receives: Other: Breaking Free Online (BFO) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Digital Treatment Interventions
Number of enrolled pilot trial participants, overall and by intervention.
Measured: End of enrollment (~6 months)
Overall Substance Use Treatment Engagement
The number and percentage of modules, and homework modules, completed.
Measured: End of enrollment (~6 months)
Perceived Treatment Utility
Mean module and overall treatment rating using a 4-question "Module Utility" scale created by the research team. This is an 11-point Likert scale (0-10) rating the importance, relevance, usefulness, and likeliness to recommend treatment, with higher scores indicating better utility.
Measured: End of enrollment (~6 months)
Efficacy of Treatment Module Content
Treatment modules include quizzes with several true or false questions (5-10 questions per module) that assess individuals' understanding of the content learned. Overall performance on intervention quizzes in treatment modules will be examined using the total number of questions answered correctly, with higher scores indicating a better understanding of the treatment modules.
Measured: End of enrollment (~6 months)
Efficacy of Digital Treatment Interventions for Substance Use
Substance use relapse documented by the CSC staff.
Measured: Study follow-up (~3 months post-treatment completion)
Efficacy of Digital Treatment Interventions for Recidivism
Institutional readmission documented by the CSC staff.
Measured: Study follow-up (~3 months post-treatment completion)
Secondary outcomes (3)
Between-Intervention Feasibility Outcomes
Comparing treatment utility ratings on the 4-question "Module Utility" questionnaire between interventions.
Measured: End of enrollment (~6 months)
Between-Intervention Efficacy Outcomes for Substance Use
Comparing substance use relapse as documented by CSC staff between treatment groups.
Measured: Study follow-up (~3 months post-treatment completion)
Between-Intervention Efficacy Outcomes for Recidivism
Comparing institutional readmission as documented by CSC staff between treatment groups.
Measured: Study follow-up (~3 months post-treatment completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start25 Feb 2026
- Primary completionJul 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance Use Disorder (SUD)Studies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Collaborators
- Correctional Service of Canada
- Responsible party
- Principal investigator, James MacKillop, St. Joseph's Healthcare Hamilton
- Investigators
- James MacKillop, PhD, CPsych, FCAHS, Principal investigator, Peter Boris Centre for Addictions Research, St Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07342218
- Sponsor's protocol ID
- 18879
- Other IDs
- Memorandum of Understanding
- Acronym
- PROCESS
- Status last verified
- Nov 2025
- First submitted
- 8 Dec 2025
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data from criminal justice-involved participants is considered sensitive and the Correctional Services of Canada prohibits the sharing of individual participant data with other organizations. Therefore, we will not be sharing IPD. Only aggregate and anonymized data in written research reports will be publicly shared.