Online Cognitive Behavioural Therapy + Peer Support for Substance Use Disorder

Overseen By Lena C. Quilty, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Centre for Addiction and Mental Health

Disqualifiers: Psychosis, Mania, Acute psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

225 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness and cost-efficiency of an online cognitive behavioral therapy (CBT) tool called Breaking Free Online for individuals with substance use disorder. Participants will receive either group peer support, access to the online CBT program, or access to the online CBT program with individual peer support. The goal is to determine which approach best aids in managing substance use issues. Those who have used alcohol or other substances within the past 30 days and are registered with an addiction program may find this trial suitable. As an unphased trial, it provides a unique opportunity to explore innovative treatment options for substance use disorder.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It might be best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that Breaking Free Online, an online program using cognitive behavioral therapy, was generally safe and well-tolerated by users. Research shows that participants using this digital therapy for substance use disorders did not report any major negative effects. Another study found that adding individual peer support to the online therapy did not increase negative effects. This suggests that both the online therapy and its combination with peer support are safe options for people seeking help with substance use issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they offer innovative approaches to managing substance use disorder. Unlike traditional methods like in-person therapy or medication-assisted treatments, the online Cognitive Behavioural Therapy (CBT) provides flexibility through a digital platform called Breaking Free Online (BFO), enabling users to engage with therapy at their own pace. Additionally, the combination of BFO with individual peer support introduces a unique element, where individuals receive guidance and encouragement from peers who have lived experience, potentially enhancing engagement and success rates. These features represent a shift towards more personalized and accessible treatment options, which could improve outcomes for individuals struggling with substance use.

What evidence suggests that this trial's treatments could be effective for substance use disorder?

Research shows that Breaking Free Online (BFO), an online program based on cognitive behavioral therapy (CBT), can assist people with substance use problems. Studies have found that BFO users often reduce their substance use and experience improvements in depression and anxiety. In this trial, one group will receive BFO alone, while another will receive BFO plus individual peer support, potentially enhancing effectiveness through personalized help and encouragement. Additionally, a separate group will participate in group peer support sessions. CBT is known for helping people change negative thoughts and behaviors, and BFO applies this method online. These positive findings suggest that BFO, especially with peer support, could be a valuable option for those seeking help with substance use issues. ^{1 3 6 7 8}

Who Is on the Research Team?

Lena C. Quilty, PhD

Principal Investigator

Centre for Addiction and Mental Health

Are You a Good Fit for This Trial?

This trial is for adults over 18 who speak English, are currently dealing with substance use disorder, and have used substances within the last month. They must be registered with CAMH Addictions Program outpatient services and willing to follow study rules. People with current psychosis or mania, severe psychiatric disorders needing urgent care, significant neurological issues, or any factors that would prevent full participation cannot join.

Inclusion Criteria

Fluency in English

Have used alcohol or substances within the past 30 days

Current substance use disorder

Exclusion Criteria

Current psychiatric disorder requiring care more urgently than substance use, including acute intoxication or withdrawal requiring medical attention

Inability to read at a sixth grade level

Any known practical factors that would preclude participation (e.g., extended absences)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive clinical monitoring with group peer support, Breaking Free Online, or Breaking Free Online with individual peer support

8 weeks

Biweekly study assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Monthly assessments

What Are the Treatments Tested in This Trial?

Interventions

• Group Peer Support
• Individual Peer Support
• Online Cognitive Behavioural Therapy

Trial Overview The study tests Breaking Free Online's effectiveness in treating substance use disorder. Participants will receive standard care plus group peer support, access to Breaking Free Online alone, or both the online program and individual peer support to see which method works best.

How Is the Trial Designed?

Group I: Online Cogntivie Behavioural Therapy Experimental Treatment 1 Intervention

Breaking Free Online (BFO) is an online intervention, supporting adults struggling with substance use. It provides psychoeducation and skills building exercises in CBT and compatible approaches. The intervention strategies contained within BFO are provided via a six-domain biopsychosocial model used in CBT. Each domain of the model corresponds to a module in the BFO program which contains psychoeducation and an 'action' strategy to facilitate behaviour change. Data captured at the baseline assessment is used by the program to provide feedback to the individual on their levels of functioning across the six domains. The program then guides the user to concentrate on intervention strategies for domains with the greatest level of impairment. All groups will receive 'clinical monitoring,' including biweekly study assessments during the acute treatment period and monthly assessments during the six month follow-up period.

Group II: Online Cognitive Behavioural Therapy Plus Individual Peer Support Experimental Treatment 2 Interventions

BFO delivered with peer support will comprise BFO with at least weekly contact with a peer with lived experience. Peer support workers will receive training on how to facilitate participant engagement with and progress through the BFO program, as well as a weekly session plan. As part of this training, peer support workers will be given their own access code to use BFO and be encouraged to use the program. Session One constitutes an initial orienting to the program. Subsequent sessions review each information and action strategy in the BFO program, with a series of prompts to guide peer support of this content. All groups will receive 'clinical monitoring,' including biweekly study assessments during the acute treatment period and monthly assessments during the six month follow-up period.

Group III: Group Peer Support Active Control 1 Intervention

The control condition will consist of group peer support facilitated by trained peers and offered through the Community Addictions Peer Support Association (CAPSA). The group meets weekly and will offer participants a space to share their experiences and receive support. All groups will receive 'clinical monitoring,' including biweekly study assessments during the acute treatment period and monthly assessments during the six month follow-up period.

Online Cognitive Behavioural Therapy is already approved in United Kingdom for the following indications:

Approved in United Kingdom as Breaking Free Online for:

• Substance use disorder
• Co-occurring mental health problems

Who Is Running the Clinical Trial?

Centre for Addiction and Mental Health

Lead Sponsor

Trials

388

Recruited

84,200+

Community Addictions Peer Support Association (CAPSA)

Collaborator

Trials

1

Recruited

230+

Breaking Free Online (BFO)

Collaborator

Trials

1

Recruited

230+

Published Research Related to This Trial

A web-based psychosocial intervention (TES) was found to be highly acceptable among participants entering addiction treatment who lacked recent internet access, with those participants rating the modules more favorably than those with internet access.

The intervention showed potential clinical benefits, particularly in improving retention rates among participants who were not abstinent at baseline and had internet access, suggesting that TES can be an effective addition to traditional treatment methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent Internet Use and Associations with Clinical Outcomes among Patients Entering Addiction Treatment Involved in a Web-Delivered Psychosocial Intervention Study. Tofighi, B., Campbell, AN., Pavlicova, M., et al.[2018]

Web-based interventions for substance use disorders are currently under-researched, with no large randomized controlled trials available, indicating a significant gap in the evidence base for their effectiveness.

Despite the limited and flawed literature, there is a strong demand for internet-based interventions, suggesting they could be as effective as traditional therapy for less severe cases of substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-based interventions for substance use disorders: a qualitative review. Copeland, J., Martin, G.[2006]

The INTERACT trial is evaluating a novel integrated online cognitive behavioral therapy (CBT) that combines live therapist-led sessions with online resources, aiming to improve adherence and effectiveness in treating depression among 434 participants from primary care settings.

This integrated approach, which includes nine live sessions and additional online materials, could potentially enhance access to effective depression treatment and may be introduced into existing psychological services if proven clinically and cost-effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated therapist and online CBT for depression in primary care (INTERACT): study protocol for a multi-centre randomised controlled trial. Tallon, D., Thomas, L., Brabyn, S., et al.[2023]

Clients using the Therapeutic Education System (TES) showed significant improvements in knowledge and coping strategies compared to those receiving standard treatment, indicating the potential efficacy of this web-based program.

Despite the positive outcomes for clients, counselors were hesitant to refer clients to TES, and engagement was low without incentive systems, suggesting that integration with motivational strategies is necessary for successful implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and effectiveness of computer-based therapy in community treatment. Brooks, AC., Ryder, D., Carise, D., et al.[2022]

A web-based cognitive-behavioral intervention for reducing substance use and depression was found to be feasible, showing significant reductions in substance use days, severity of use, and depressive symptoms across all treatment groups.

However, the web-based program was not more effective than traditional treatment methods, indicating that while it is a viable option, further research with larger samples is needed to fully assess its effectiveness and cost-effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Web-Based Intervention to Reduce Substance Abuse and Depression: A Three Arm Randomized Trial in Mexico. Tiburcio, M., Lara, MA., Martínez, N., et al.[2019]

Peer recovery support services (PRSS) show promise in improving outcomes for individuals with substance use disorder (SUD), including reduced substance use, lower relapse rates, and increased treatment satisfaction, based on a systematic review of various studies.

However, the existing research has significant methodological limitations, such as inconsistent definitions of peer roles and a lack of appropriate comparison groups, highlighting the need for more rigorous studies to better understand the efficacy and implementation of PRSS.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lived Experience in New Models of Care for Substance Use Disorder: A Systematic Review of Peer Recovery Support Services and Recovery Coaching. Eddie, D., Hoffman, L., Vilsaint, C., et al.[2023]

Cognitive Behaviour Therapy (CBT) shows limited effectiveness for treating co-occurring depression and substance use, with only modest improvements compared to no treatment, based on a review of 12 clinical trials.

While CBT is not proven to be more effective than other psychotherapies, it does lead to consistent improvements in both depression and substance use outcomes, and these benefits appear to increase over time during follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behaviour therapy (CBT) for the treatment of co-occurring depression and substance use: current evidence and directions for future research. Hides, L., Samet, S., Lubman, DI.[2018]

In a study involving 77 participants, those with higher risk-taking behaviors struggled more with completing sessions and homework in computer-assisted cognitive-behavioral therapy (CBT), leading to poorer substance use outcomes.

The findings suggest that while computer-assisted CBT may offer individualized pacing, it may still be challenging for substance users with cognitive limitations, particularly those who are more prone to risk-taking.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive function and treatment response in a randomized clinical trial of computer-based training in cognitive-behavioral therapy. Carroll, KM., Kiluk, BD., Nich, C., et al.[2021]

The study evaluated the feasibility of a computer-based cognitive behavioral therapy program (CBT4CBT) as an addition to standard residential treatment for women with substance use disorders, involving 63 participants in total (34 in the CBT4CBT group and 29 in the treatment as usual group).

Results indicated that women using CBT4CBT showed a lower likelihood of relapse, longer time to relapse, and fewer days of substance use during the 12-week follow-up, suggesting that CBT4CBT could enhance treatment outcomes in residential settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pilot randomized trial of CBT4CBT for women in residential treatment for substance use disorders. Kelpin, SS., Parlier-Ahmad, AB., Jallo, N., et al.[2022]

A study involving 73 individuals with substance dependence showed that those who received computer-assisted cognitive behavioral therapy (CBT4CBT) maintained lower drug use over a 6-month follow-up compared to those receiving standard treatment.

The positive effects of CBT4CBT were durable, indicating that this computer-based therapy can provide lasting benefits in reducing substance use even after treatment has ended.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enduring effects of a computer-assisted training program for cognitive behavioral therapy: a 6-month follow-up of CBT4CBT. Carroll, KM., Ball, SA., Martino, S., et al.[2021]

A study involving 17 peer support workers in Egypt revealed that these individuals play a crucial role in helping others with substance use disorders by providing recovery support through shared experiences.

The research highlighted the need for greater organizational and governmental support for peer support workers, as well as public education about their important role in recovery, to enhance the effectiveness of substance use disorder interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experiences of peer support workers supporting individuals with substance use disorders in Egypt: phenomenological analysis. Ibrahim, N., Selim, A., Ng, F., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10237524/

Examining outcomes for service users accessing ... Breaking Free Online (BFO), a computer-assisted therapy (CAT) program for substance use disorders (SUD), has been available across UK ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05127733

Online Cognitive Behavioural Therapy for Substance Use ... A total of 225 outpatients receiving standard care for substance use disorder from the Centre for Addiction and Mental Health will be randomized to receive ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36523236/

Peer support and online cognitive behavioural therapy for ... Campbell Family Mental Health Research Institute, Centre for Addiction and Mental Health, Toronto, Ontario, Canada [e-mail]. 2 ...

4. c4tbh.org c4tbh.org/program-review/breaking-free-online-bfo/

Breaking Free Online (BFO) Breaking Free Online (BFO) is a web-based program that allows individuals to tailor their own substance use and mental health treatment.

5. bmjopen.bmj.com bmjopen.bmj.com/content/12/12/e064360

Peer support and online cognitive behavioural therapy for ... The primary outcome is substance use frequency; secondary outcomes include substance use problems, depression, anxiety, quality of life, treatment engagement ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9748960/

Peer support and online cognitive behavioural therapy for ... The goal of this study is to evaluate the efficacy and cost-effectiveness of Breaking Free Online (BFO), an online cognitive-behavioural intervention for ...

7. withpower.com withpower.com/trial/phase-substance-related-disorders-9-2021-e1323

Online Cognitive Behavioural Therapy + Peer Support for ... The purpose of this study is to evaluate the efficacy and cost-effectiveness of Breaking Free Online, in a comparison of outpatients seeking treatment for ...

8. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2824103

A Digital Cognitive Behavioral Therapy Program for Adults ... A meta-analysis showed no significant difference in substance use outcomes when CBT was compared with another evidence-based treatment.