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

205 Participants Needed

Trial Summary

What is the purpose of this trial?

Alcohol misuse is a common and disabling problem and refers to alcohol consumption that causes harm to the drinker, others, and/or greater society. Internet-delivered cognitive behaviour therapy (ICBT) shows considerable promise as a convenient treatment for alcohol misuse. The overall goal of ICBT for alcohol misuse is typically behavioural change, measured in terms of reduction of drinks consumed, as opposed to abstinence. These interventions can be delivered in a therapist-guided format or self-guided format. In past research on ICBT for alcohol misuse, stakeholders (e.g., patients, providers, and academics) highlighted the importance of ensuring that ICBT meets the needs of diverse residents of Saskatchewan, and that ICBT takes into account factors such as psychological comorbidity. Therefore, the goals of the current trial are to: 1) incorporate additional patient narratives to assist clients in learning how diverse individuals apply skills to their lives; and 2) provide additional optional resources to address potential co-morbid concerns. The study aims to examine how these materials are evaluated by clients. Furthermore, we will also examine the overall engagement and outcomes of the enhanced ICBT course for alcohol misuse benchmarked with past findings.

Research Team

Heather Hadjistavropoulos, PhD

Principal Investigator

University of Regina

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+