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

NCT ID: NCT07342218

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-31
• Study Completion Date: 2027-03-31

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.

Conditions

Substance Use Disorder (SUD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Computer-Based Training for Cognitive Behavioural Therapy

Participants will complete a 7-module digital treatment intervention for substance use, using cognitive behavioural therapy practices.

Group Type: EXPERIMENTAL

Computer-Based Training for Cognitive Behavioural Therapy (CBT4CBT)

Intervention Type: 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.

Breaking Free Online

Participants will complete a 6-module digital treatment intervention for substance use, using cognitive behavioural therapy and mindfulness techniques.

Group Type: EXPERIMENTAL

Breaking Free Online (BFO)

Intervention Type: 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).

Interventions

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).

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Correctional Service of Canada

OTHER_GOV

Sponsor Role: collaborator

St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role: lead

Responsible Party

James MacKillop

Director, Peter Boris Centre for Addiction Research; Director, Michael G. DeGroote Centre for Medicinal Cannabis Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James MacKillop, PhD, CPsych, FCAHS

Role: PRINCIPAL_INVESTIGATOR

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

Locations

The Salvation Army - Ellen Osler Home

Dundas, Ontario, Canada

The St. Leonard's Society Of Hamilton

Hamilton, Ontario, Canada

Countries

Canada

Central Contacts

James MacKillop, PhD, CPsych, FCAHS

Role: CONTACT

jmackill@mcmaster.ca

905-522-1155 Ext. 3949

Facility Contacts

Meagan Hardyman

Role: primary

Meagan.Hardyman@salvationarmy.ca

(905) 627-1632

Ryan Johnson

Role: primary

ryanjohnson@slsh.ca

(905) 572-1150 EXT 332

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Memorandum of Understanding

Identifier Type: OTHER

Identifier Source: secondary_id

18879

Identifier Type: -

Identifier Source: org_study_id