Enhanced Online CBT for Alcohol Abuse

Overseen By Marcie Nugent, MSW

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Regina

Disqualifiers: Severe medical, psychiatric illness, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 20

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines an online therapy program designed to assist people in Saskatchewan who struggle with alcohol misuse. It tests two versions: one where participants navigate the program independently and another with therapist support. The trial aims to assess how these programs reduce drinking and to gather feedback on new resources addressing issues like sleep problems or stress. Individuals who drink alcohol harmfully and have internet access may be suitable candidates. However, those with severe mental health issues or other major medical conditions might not qualify. As an unphased trial, this study provides a unique opportunity to contribute to the development of innovative resources for alcohol misuse.

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 might be best to discuss this with the trial coordinators or your doctor.

What prior data suggests that Internet-delivered Cognitive Behaviour Therapy is safe for alcohol misuse?

Research has shown that internet-delivered cognitive behavior therapy (ICBT) is generally safe for treating alcohol misuse and is well-tolerated by most people. However, those with severe issues such as high alcohol use, extreme mood swings, or hallucinations should seek in-person services. This indicates that while ICBT is safe for many, it might not suit everyone.

ICBT helps individuals change their behavior to reduce alcohol consumption. It can be done independently or with a therapist's guidance. Studies have used both methods and consider them safe. Some participants might feel a bit anxious during treatment, but serious problems are rare.

For those considering joining a trial, it is important to know that ICBT has been tested and found safe for most people. Always consult a healthcare provider to ensure it is the right fit. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these new online CBT programs for alcohol abuse because they offer a unique and flexible approach. Unlike traditional therapy, which often requires in-person sessions with a therapist, the self-guided course allows participants to work through lessons and resources at their own pace, without the need for therapist support. This can be particularly appealing for individuals seeking privacy or those with busy schedules. The therapist-guided course, on the other hand, combines the convenience of online learning with professional support, potentially enhancing the effectiveness of the treatment by providing guidance and personalized feedback. Both options also address a range of related issues, like sleep quality and stress, which are often overlooked in conventional treatments.

What evidence suggests that this trial's treatments could be effective for alcohol misuse?

Research has shown that online cognitive behavior therapy (ICBT) can help reduce alcohol misuse. Studies have found that ICBT teaches people to change their drinking habits, resulting in fewer drinks per week and less harmful drinking patterns. In this trial, participants will be assigned to either a self-guided or therapist-guided ICBT course. Both self-guided and therapist-guided ICBT have proven effective, with therapist-guided versions often yielding better results. Overall, ICBT is a promising option for those seeking to manage their alcohol use. ^{6 7 8 9 10}

Who Is on the Research Team?

Heather Hadjistavropoulos, PhD

Principal Investigator

University of Regina

Are You a Good Fit for This Trial?

This trial is for individuals in Saskatchewan over the age of 17 who acknowledge they misuse alcohol and have internet access. It's not suitable for those with severe medical or psychiatric conditions, high suicide risk, heavy drug problems (excluding alcohol/cannabis), low motivation to complete online treatment, or are receiving significant mental health treatment.

Inclusion Criteria

You have a problem with drinking too much alcohol.

and have access to a computer and the Internet.

are residing in Saskatchewan;

Exclusion Criteria

You have a serious physical or mental illness, such as severe psychosis.

You have severe depression symptoms.

You have a high risk of committing suicide.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Online questionnaire and telephone interview

Treatment

Participants receive the Alcohol Change Course Enhanced (ACCE) with 6 ICBT core lessons and 8 additional resources over 8 weeks

8 weeks

Online access to lessons and resources

Mid-treatment Evaluation

Participants complete mid-treatment questionnaires and may participate in semi-structured interviews

1 week

Online questionnaires and potential interviews

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Online questionnaires at Week 20

What Are the Treatments Tested in This Trial?

Interventions

• Internet-delivered Cognitive Behaviour Therapy

Trial Overview The study tests enhanced Internet-delivered Cognitive Behaviour Therapy (ICBT) tailored for diverse populations with alcohol misuse issues. It compares self-guided and therapist-guided formats, focusing on reducing drinking rather than promoting abstinence. The enhancements include additional patient narratives and resources for co-morbid psychological issues.

How Is the Trial Designed?

Group I: Therapist-Guided Alcohol Change Course Enhanced Experimental Treatment 1 Intervention

Clients who select the therapist-guided condition will receive access to 6 ICBT core lessons, 6 associated worksheets to enhance skill acquisition, and 8 additional resources addressing potential co-morbid concerns (e.g., sleep quality, cannabis use). The 6 lessons and 6 associated worksheets are released at a rate of 1 per week over 7 weeks, with no new content being released to participants in Week 4. The 8 additional resources are available at any time during the course. Clients will receive therapist support/guidance during the 8-week intervention.

Group II: Self-Guided Alcohol Change Course Enhanced Experimental Treatment 1 Intervention

Clients who select or are assigned the self-guided condition will receive access to 6 ICBT core lessons, 6 associated worksheets to enhance skill acquisition, and 8 additional resources addressing potential co-morbid concerns (e.g., Addressing Anger, Improving Assertiveness and Communication, Changing Cannabis Use, Developing Cognitive Coping, Coping with Grief, Understanding PTSD, Improving Sleep Quality, and Managing Worry). The 6 lessons and 6 associated worksheets are released at a rate of 1 per week over 7 weeks, with no new content being released to participants in Week 4. The 8 additional resources are available at any time during the course. Clients will not receive therapist support/guidance during the 8-week intervention.

Internet-delivered Cognitive Behaviour Therapy is already approved in Canada, European Union, United States for the following indications:

Approved in Canada as ICBT for:

• Major Depressive Disorder
• Generalized Anxiety Disorder
• Post-Traumatic Stress Disorder

Approved in European Union as ICBT for:

• Depression
• Anxiety Disorders
• PTSD

Approved in United States as ICBT for:

• Depression
• Anxiety Disorders
• PTSD

Who Is Running the Clinical Trial?

University of Regina

Lead Sponsor

Trials

59

Recruited

9,100+

Saskatchewan Centre for Patient-Oriented Research

Collaborator

Trials

12

Recruited

2,000+

Saskatchewan Health Research Foundation

Collaborator

Trials

33

Recruited

5,100+

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2949875925000062

Internet-based cognitive behavioral therapy for alcohol use ... There are not enough CBT-trained therapists to meet the demands of the 29.5 million people in the US with AUD (National Institute on Alcohol Abuse and ...

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

A Digital Cognitive Behavioral Therapy Program for Adults ... ... Alcohol Abuse and Alcoholism CBT manual. Results from a pilot RCT in a sample of 68 adults with AUD indicated that this digital CBT ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9948631/

Efficacy of Cognitive Behavioral Therapy for Alcohol and ... This work is supported by funding from the National Institute on Alcohol Abuse and Alcoholism, although it does not represent official positions ...

4. tandfonline.com tandfonline.com/doi/full/10.1080/16506073.2019.1663258

A systematic review of internet-delivered cognitive ... ... alcohol misuse, problematic alcohol use, alcohol abuse and alcohol dependence). ... cognitive behavioral therapy for alcohol use disorders: efficacy as a ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8663526/

Effects of Internet-Based Cognitive Behavioral Therapy for ... ... behavioral therapy, CBT, eHealth, alcohol use, substance abuse, outcomes, help-seeking behavior, internet-based interventions, alcohol dependence, mobile phone ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7391664/

Internet-Delivered Cognitive Behavioral Therapy for ... Alcohol & Drug Abuse: Revisiting Employee Assistance Programs and Substance Use Problems in the Workplace: Key Issues and a Research Agenda.

7. sciencedirect.com sciencedirect.com/science/article/pii/S2214782921001214

Exploration of client experiences during and after treatment Clients who report severe problems with alcohol or drugs, mania, or psychosis, or clients at high risk of suicide, are referred to face-to-face services.

8. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-017-1355-6

High-intensity therapist-guided internet-based cognitive ... Cognitive behavior therapy (CBT) is widely recognized as one of the psychological treatments for alcohol problems for which evidence is most ...

9. formative.jmir.org formative.jmir.org/2023/1/e51088

Internet-Delivered Cognitive Behavioral Therapy Tailored to ... Background: Spouses and significant others (SSOs) of public safety personnel (PSP) are affected by the risks and requirements of these ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5714654/

Cognitive Behavioral Interventions for Alcohol and Drug ... Cognitive behavioral therapy (CBT) approaches have among the highest level of empirical support for the treatment of drug and alcohol use disorders.