Correctional Service of Canada Pilot Trial of Digital Substance Use Disorder Interventions (PROCESS) (PROCESS)

March 12, 2026 updated by: James MacKillop, St. Joseph's Healthcare Hamilton

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: James MacKillop, PhD, CPsych, FCAHS
  • Phone Number: 905-522-1155 Ext. 3949
  • Email: jmackill@mcmaster.ca

Study Locations

  • Canada
    • Ontario
      • Brantford, Ontario, Canada, N3T 2J6
      • Dundas, Ontario, Canada, L9H 2E8
      • Hamilton, Ontario, Canada, L8L 2P2
        • Recruiting
        • The St. Leonard's Society Of Hamilton
        • Contact:
      • Hamilton, Ontario, Canada, L8N 2V2
        • Recruiting
        • St Leonard's Clinton House
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

- Individuals who have never served a custodial sentence with the CSC

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Computer-Based Training for Cognitive Behavioural Therapy
Participants will complete a 7-module digital treatment intervention for substance use, using cognitive behavioural therapy practices.
Other: Computer-Based Training for Cognitive Behavioural Therapy (CBT4CBT)
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.
Experimental: Breaking Free Online
Participants will complete a 6-module digital treatment intervention for substance use, using cognitive behavioural therapy and mindfulness techniques.
Other: Breaking Free Online (BFO)
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility of Digital Treatment Interventions
Time Frame: End of enrollment (~6 months)
Number of enrolled pilot trial participants, overall and by intervention.
End of enrollment (~6 months)
Overall Substance Use Treatment Engagement
Time Frame: End of enrollment (~6 months)
The number and percentage of modules, and homework modules, completed.
End of enrollment (~6 months)
Perceived Treatment Utility
Time Frame: End of enrollment (~6 months)
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.
End of enrollment (~6 months)
Efficacy of Treatment Module Content
Time Frame: End of enrollment (~6 months)
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.
End of enrollment (~6 months)
Efficacy of Digital Treatment Interventions for Substance Use
Time Frame: Study follow-up (~3 months post-treatment completion)
Substance use relapse documented by the CSC staff.
Study follow-up (~3 months post-treatment completion)
Efficacy of Digital Treatment Interventions for Recidivism
Time Frame: Study follow-up (~3 months post-treatment completion)
Institutional readmission documented by the CSC staff.
Study follow-up (~3 months post-treatment completion)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Between-Intervention Feasibility Outcomes
Time Frame: End of enrollment (~6 months)
Comparing treatment utility ratings on the 4-question "Module Utility" questionnaire between interventions.
End of enrollment (~6 months)
Between-Intervention Efficacy Outcomes for Substance Use
Time Frame: Study follow-up (~3 months post-treatment completion)
Comparing substance use relapse as documented by CSC staff between treatment groups.
Study follow-up (~3 months post-treatment completion)
Between-Intervention Efficacy Outcomes for Recidivism
Time Frame: Study follow-up (~3 months post-treatment completion)
Comparing institutional readmission as documented by CSC staff between treatment groups.
Study follow-up (~3 months post-treatment completion)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Joseph's Healthcare Hamilton

Collaborators

Correctional Service of Canada

Investigators

  • Principal Investigator: James MacKillop, PhD, CPsych, FCAHS, Peter Boris Centre for Addictions Research, St Joseph's Healthcare Hamilton

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

December 8, 2025

First Submitted That Met QC Criteria

January 7, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18879
  • Memorandum of Understanding (Other Identifier: Correctional Service of Canada)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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