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NCT Number: NCT07342218

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

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.

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Key information

Conditions

Substance Use Disorder (SUD) Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Salvation Army Booth Centre, Brantford, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Feasibility of Digital Treatment Interventions

    Time frame: End of enrollment (~6 months)

    Number of enrolled pilot trial participants, overall and by intervention.

  2. Overall Substance Use Treatment Engagement

    Time frame: End of enrollment (~6 months)

    The number and percentage of modules, and homework modules, completed.

  3. 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.

  4. 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.

  5. 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.

  6. Efficacy of Digital Treatment Interventions for Recidivism

    Time frame: Study follow-up (~3 months post-treatment completion)

    Institutional readmission documented by the CSC staff.

Secondary outcomes

  1. Between-Intervention Feasibility Outcomes

    Time frame: End of enrollment (~6 months)

    Comparing treatment utility ratings on the 4-question "Module Utility" questionnaire between interventions.

  2. 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.

  3. 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 contacts

Contact information is provided by the study sponsor or research team.

James MacKillop, PhD, CPsych, FCAHS

CONTACT

[email protected]

905-522-1155 Ext. 3949

Sponsors and collaborators

Lead sponsor

St. Joseph's Healthcare Hamilton

Other

Collaborators

  • Correctional Service of Canada

Registry information

Official study 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

Acronym: PROCESS

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jan 15, 2026
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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