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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
St. Joseph's Healthcare Hamilton

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Correctional Service of Canada

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 25, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 8, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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