Recruiting

Digital Treatments

Sponsor:

St. Joseph's Healthcare Hamilton

Code:

NCT07342218

Conditions

Substance Use Disorder (SUD)

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

Interventions

Breaking Free Online (BFO)

Computer-Based Training for Cognitive Behavioural Therapy (CBT4CBT)

Study Details

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 ID

NCT07342218

Start date

Feb 25, 2026

Status verified date

Nov, 2025

Completion date

Mar, 2027

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Not accepted

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 Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

experimental: Breaking Free Online

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

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).

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.

Primary outcome measure

  • Feasibility of Digital Treatment Interventions [ Time Frame: End of enrollment (~6 months) ]
  • Overall Substance Use Treatment Engagement [ Time Frame: End of enrollment (~6 months) ]
  • Perceived Treatment Utility [ Time Frame: End of enrollment (~6 months) ]
  • Efficacy of Treatment Module Content [ Time Frame: End of enrollment (~6 months) ]
  • Efficacy of Digital Treatment Interventions for Substance Use [ Time Frame: 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) ]

Central Contacts and Locations

Central contacts

James MacKillop, PhD, CPsych, FCAHS

905-522-1155 Ext. 3949jmackill@mcmaster.ca

Locations

Salvation Army Booth Centre

Recruiting

Brantford, Ontario, Canada, N3T 2J6

Contacts

Joshua Patenaude

519-753-4193joshua.patenaude@salvationarmy.ca

The Salvation Army - Ellen Osler Home

Recruiting

Dundas, Ontario, Canada, L9H 2E8

Contacts

Meagan Hardyman

(905) 627-1632Meagan.Hardyman@salvationarmy.ca

The St. Leonard's Society Of Hamilton

Recruiting

Hamilton, Ontario, Canada, L8L 2P2

Contacts

Ryan Johnson

(905) 572-1150 EXT 332ryanjohnson@slsh.ca

St Leonard's Clinton House

Recruiting

Hamilton, Ontario, Canada, L8N 2V2

Contacts

Colin Avery

905-529-8494cavery@slsh.ca

More Information

Sponsor

St. Joseph's Healthcare Hamilton

Last update posted

Mar 13, 2026

Last verified

Nov, 2025

Keywords

  • incarceration
  • federal offender
  • substance use disorder
  • cognitive behavioural therapy
  • mindfulness
  • digital treatment
  • substance use treatment
  • pilot trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Joseph's Healthcare Hamilton on 2026-03-13.