Digital Interventions for Substance Use Disorder
(PROCESS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores digital treatments for substance use problems in individuals recently released from prison. It compares two programs: one teaches cognitive behavioral therapy (CBT) through a computer (Computer-Based Training for Cognitive Behavioral Therapy, or CBT4CBT), and the other combines CBT with mindfulness techniques (Breaking Free Online, or BFO). Researchers will assess participant engagement with these digital tools and their effectiveness in preventing relapse and re-incarceration. This trial suits individuals with a history of substance use problems who currently reside in a community correctional facility. As an unphased trial, it offers a unique opportunity to contribute to innovative research that could shape future digital treatments for substance use.
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that Breaking Free Online (BFO) is generally safe and well-tolerated. Studies have found that people using BFO often experience improved quality of life and mental health, with reduced depression and anxiety. This suggests the treatment does not cause significant harm.
For Computer-Based Training for Cognitive Behavioral Therapy (CBT4CBT), research indicates it is also safe for individuals with substance use disorders. Users of CBT4CBT have reported reduced substance use symptoms and have learned helpful skills to manage their condition. While some reviews have questioned its effectiveness, they do not raise safety concerns.
Both digital treatments appear to be safe options for assisting individuals with substance use problems.12345Why are researchers excited about this trial's treatments?
Researchers are excited about these treatments for substance use disorder because they leverage digital platforms to deliver cognitive behavioral therapy (CBT) in innovative ways. Breaking Free Online stands out by integrating mindfulness techniques with CBT, offering a holistic approach that's accessible online. Meanwhile, Computer-Based Training for Cognitive Behavioural Therapy (CBT4CBT) provides a structured, 7-module digital experience, making CBT more engaging and convenient. Unlike traditional in-person therapy sessions, these digital interventions can be accessed from anywhere, providing flexibility and potentially increasing patient adherence and success rates.
What evidence suggests that this trial's digital treatments could be effective for substance use disorder?
Research has shown that Breaking Free Online (BFO), one of the treatments in this trial, helps reduce substance use, dependence, depression, and anxiety. Users report improved mental health and fewer social problems after using the program. Studies confirm that this digital treatment effectively supports individuals dealing with substance use issues.
For Computer-Based Training for Cognitive Behavioural Therapy (CBT4CBT), another treatment option in this trial, research indicates a clear reduction in symptoms of substance use disorder (SUD). Participants have developed better skills and strategies to manage their substance use. Both treatments in this trial have a strong history of helping individuals reduce their reliance on substances and improve overall well-being.12467Who Is on the Research Team?
James MacKillop, PhD, CPsych, FCAHS
Principal Investigator
Peter Boris Centre for Addictions Research, St Joseph's Healthcare Hamilton
Are You a Good Fit for This Trial?
This trial is for individuals aged 18-55 who have a history of substance use problems, are on parole with conditions to abstain from substances, and have served time in the Correctional Services of Canada. Participants must currently reside in a Community Correctional Centre or Community-Based Residential Facility.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants complete digital treatment interventions for substance use, using cognitive behavioural therapy and mindfulness techniques over a 6-month period
Follow-up
Participants are monitored for substance use relapse and re-incarceration after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Breaking Free Online (BFO)
- Computer-Based Training for Cognitive Behavioural Therapy (CBT4CBT)
Trial Overview
The study tests two digital treatments for substance use issues in ex-prisoners: Computer-Based Training for Cognitive Behavioural Therapy (CBT4CBT) and Breaking Free Online (BFO). It measures how well participants engage with these treatments over six months and tracks relapse and re-incarceration rates.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Participants will complete a 7-module digital treatment intervention for substance use, using cognitive behavioural therapy practices.
Participants will complete a 6-module digital treatment intervention for substance use, using cognitive behavioural therapy and mindfulness techniques.
Find a Clinic Near You
Who Is Running the Clinical Trial?
St. Joseph's Healthcare Hamilton
Lead Sponsor
Correctional Service of Canada
Collaborator
Citations
Examining outcomes for service users accessing ...
Research around the efficacy of BFO has demonstrated significant reductions in substance use, substance dependence, depression and anxiety, and ...
Breaking Free Online (BFO)
Results showed that social impairment, depression, anxiety, drug use, and social anxiety symptoms all decreased significantly from baseline to ...
An Observational Study of a Digital Substance Use and ...
In this study, we report results of an analysis of clients' use patterns, engagement, and outcomes of the BFO program, as well as the ...
Recovery Program for Alcohol & Drugs
Examining effectiveness of tailorable computer-assisted therapy programmes for substance misuse: Programme usage and clinical outcomes data from Breaking Free ...
Examining effectiveness of tailorable computer-assisted ...
Examining effectiveness of tailorable computer-assisted therapy programmes for substance misuse: Programme usage and clinical outcomes data from Breaking Free ...
6.
hriresearch.s3.amazonaws.com
hriresearch.s3.amazonaws.com/uploads/2022/08/20220711-HRI-HDGH-BFO-Evaluation-Final-Report.pdfEvaluation of the Implementation and Delivery of Breaking ...
assessments (n=64), overall results demonstrated significant improvements in client outcomes, including changes in quality of life, depression and anxiety, ...
Examining effectiveness of tailorable computer-assisted ...
Examining effectiveness of tailorable computer-assisted therapy programmes for substance misuse: Programme usage and clinical outcomes data from Breaking Free ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.