Enhancing Internet-delivered Cognitive Behaviour Therapy for Alcohol Misuse

NCT05555264 | Completed

• 1 other identifier: 2022-082
• Study Type: interventional
• Target: 205
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Alcohol Misuse

Keywords

Internet-delivered cognitive behaviour therapy; Alcohol misuse; Substance misuse; Patient Narratives; Co-morbidities

Outcome Measures

Primary Outcomes (5)

• Drinks Preceding Week as Measured by Timeline Followback (TLFB)

  Change in preceding week alcohol consumption in terms of the total number of standard drinks consumed on each day during the previous 7 days.

  Baseline (screening), Week 4 (mid-treatment), Week 7 (post-treatment), Week 20 (follow-up)

• Heavy Drinking Days Preceding Week as Measured by Timeline Followback (TLFB)

  Change in preceding week alcohol consumption in terms of the total number of heavy drinking days during the previous 7 days.

  Baseline (screening), Week 4 (mid-treatment), Week 7 (post-treatment), Week 20 (follow-up)

• Patient Reflections Questionnaire

  Change in clients' opinions of and satisfaction with the personal reflections incorporated throughout the ACCE. This questionnaire has been developed by the research team, and does not have a sum score.

  Week 4 (mid-treatment), Week 7 (post-treatment)

• Additional Resources Questionnaire (Midpoint)

  Clients' opinions of and satisfaction with the 8 additional resources offered alongside the ACCE that they have reviewed since the beginning of treatment. This questionnaire has been developed by the research team, and does not have a sum score.

  Week 4 (mid-treatment)

• Additional Resources Questionnaire

  Clients' opinions of and satisfaction with the 8 additional resources offered alongside the ACCE that they have reviewed since the Midpoint questionnaire. This questionnaire has been developed by the research team, and does not have a sum score.

  Week 8

Secondary Outcomes (19)

• Patient Health Questionnaire 9-item (PHQ-9)

  Baseline (screening), Week 1, Week 4 (mid-treatment), Week 7 (post-treatment), Week 20 (follow-up)

• Generalized Anxiety Disorder 7-item (GAD-7)

  Baseline (screening), Week 7 (post-treatment), Week 20 (follow-up)

• Alcohol Use Disorder Identification Test (AUDIT)

  Baseline (screening), Week 7 (post-treatment), Week 20 (follow-up)

• Penn Alcohol Craving Scale

  Baseline (screening), Week 7 (post-treatment), Week 20 (follow-up)

• The Cannabis Use Disorder Identification Test - Revised (CUDIT-R)

  Baseline (screening), Week 7 (post-treatment), Week 20 (follow-up)

Other Outcomes (3)

• Family History Density - Alcohol (FHD-Alcohol)

  Baseline (screening)

• Drug Use Disorder Identification Test (DUDIT)

  Baseline (screening)

• Homework Reflection Questionnaire

  Weeks 2-8

Study Arms (2)

Self-Guided Alcohol Change Course Enhanced

EXPERIMENTAL

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.

Behavioral: Self-Guided

Therapist-Guided Alcohol Change Course Enhanced

EXPERIMENTAL

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.

Behavioral: Therapist-Guided

Interventions

Self-Guided BEHAVIORAL

Clients who select or are assigned the self-guided condition will be able to contact the Online Therapy Unit regarding any technical issues through the secure treatment platform; monitoring staff will respond by secure message to messages received however, no psychological intervention will be provided by monitoring staff as part of the ACCE treatment intervention. If there is a significant clinical issue requiring attention (e.g., a sudden increase in symptoms) monitoring staff will make a telephone call and crisis support will be provided if necessary.

Self-Guided Alcohol Change Course Enhanced

Therapist-Guided BEHAVIORAL

Therapists will spend \~15 minutes/week communicating with each client who selects the therapist-guided condition, primarily using secure messages. Phone calls will only be made if there is a significant clinical issue requiring attention that the therapist does not feel can be addressed in a message (e.g., a question about the materials that cannot be easily addressed in a text format, a sudden increase in symptoms, increased suicide risk).

Therapist-Guided Alcohol Change Course Enhanced

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• are residing in Saskatchewan;
• are over the age of 17;
• endorse alcohol misuse;
• and have access to a computer and the Internet.

You may not qualify if:

• have a severe medical condition and/or psychiatric illness (e.g., psychosis);
• show signs of severe depression;
• are assessed as being at high risk of suicide;
• have severe problems with drugs (other than alcohol and/or cannabis; measured by scoring \> 24 on the DUDIT, or by clinical assessment);
• have severe cognitive impairment;
• demonstrate low motivation or concerns regarding completing the online treatment program;
• or do/will engage in ongoing or impending significant mental health treatment (i.e., \>2 visits per month).

Sponsors & Collaborators

• University of Regina: lead
• Saskatchewan Health Research Foundation: collaborator
• Saskatchewan Centre for Patient-Oriented Research: collaborator

Study Sites (1)

Online Therapy Unit, University of Regina

Regina, Saskatchewan, S4S 0A2, Canada

Location

Study Officials

• Heather Hadjistavropoulos, PhD

  University of Regina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each client will choose one of the following: self-guided Alcohol Change Course Enhanced (8 weeks), therapist-guided Alcohol Change Course Enhanced (8 weeks)

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: September 26, 2022
• Study Start: September 16, 2022
• Primary Completion: July 3, 2024
• Study Completion: July 3, 2025
• Last Updated: May 5, 2026

Record last verified: 2026-04

Locations

CA (1)