NCT07342218

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
10mo left

Started Feb 2026

Geographic Reach
1 country

4 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Feb 2026Mar 2027

First Submitted

Initial submission to the registry

December 8, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

February 25, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

March 13, 2026

Status Verified

November 1, 2025

Enrollment Period

4 months

First QC Date

December 8, 2025

Last Update Submit

March 12, 2026

Conditions

Keywords

incarcerationfederal offendersubstance use disordercognitive behavioural therapymindfulnessdigital treatmentsubstance use treatmentpilot trial

Outcome Measures

Primary Outcomes (6)

  • Feasibility of Digital Treatment Interventions

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

    End of enrollment (~6 months)

  • Overall Substance Use Treatment Engagement

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

    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.

    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.

    End of enrollment (~6 months)

  • Efficacy of Digital Treatment Interventions for Substance Use

    Substance use relapse documented by the CSC staff.

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

  • Efficacy of Digital Treatment Interventions for Recidivism

    Institutional readmission documented by the CSC staff.

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

Secondary Outcomes (3)

  • Between-Intervention Feasibility Outcomes

    End of enrollment (~6 months)

  • Between-Intervention Efficacy Outcomes for Substance Use

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

  • Between-Intervention Efficacy Outcomes for Recidivism

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

Study Arms (2)

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.

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.

Other: Breaking Free Online (BFO)

Interventions

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).

Breaking Free Online

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.

Computer-Based Training for Cognitive Behavioural Therapy

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Salvation Army Booth Centre

Brantford, Ontario, N3T 2J6, Canada

RECRUITING

The Salvation Army - Ellen Osler Home

Dundas, Ontario, L9H 2E8, Canada

RECRUITING

The St. Leonard's Society Of Hamilton

Hamilton, Ontario, L8L 2P2, Canada

RECRUITING

St Leonard's Clinton House

Hamilton, Ontario, L8N 2V2, Canada

RECRUITING

MeSH Terms

Conditions

Substance-Related Disorders

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • James MacKillop, PhD, CPsych, FCAHS

    Peter Boris Centre for Addictions Research, St Joseph's Healthcare Hamilton

    PRINCIPAL INVESTIGATOR

Central Study Contacts

James MacKillop, PhD, CPsych, FCAHS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, Peter Boris Centre for Addiction Research; Director, Michael G. DeGroote Centre for Medicinal Cannabis Research

Study Record Dates

First Submitted

December 8, 2025

First Posted

January 15, 2026

Study Start

February 25, 2026

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

March 13, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

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.

Locations