Adaptive Actions and Alcohol Use Outcomes During Internet-delivered Cognitive Behaviour Therapy

NCT07021053 | Recruiting

• 1 other identifier: 2022-082b
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study investigates an Internet-delivered Cognitive Behaviour Therapy (ICBT) intervention for alcohol misuse, called the Alcohol Change Course Enhanced (ACCE). The intervention will be offered through the Online Therapy Unit, which is a routine care ICBT clinic. The primary objective of the study is to examine whether engagement in adaptive actions measured by the Things You Do Questionnaire (TYDQ), including healthy thinking, meaningful activities, social connections, healthy habits and goal setting - increase during ICBT for alcohol misuse. Using data collected during routine care, the relationship between adaptive actions and alcohol use will be investigated, and specifically explore if the frequency of adaptive actions increases as alcohol use reduces during the intervention.

Conditions

Alcohol Misuse

Keywords

Internet-delivered cognitive behaviour therapy; Alcohol misuse

Outcome Measures

Primary Outcomes (2)

• Changes in Alcohol Consumption

  Measured with Total Number of Drinks in the Last Week. Clients report the number of standard drinks consumed on each of the preceding 7 days, with numeric values. Two variables are derived for each time point (screening, mid-treatment, post-treatment, and follow-up): 1) total weekly consumption, calculated as the sum of standard drinks during the preceding 7 days, and 2) number of heavy drinking days (HDDs) in the past week. HDDs are defined as days on which consumption exceeds gender-specific thresholds defined by the National Institute on Alcohol Abuse and Alcoholism (i.e., 4 or more standard drinks for women, 5 or more for men).

  Baseline (Screening), weeks 4, 6 (post-treatment) and 18 post enrollment

• Changes in Adaptive Actions

  Measured using the Things You Do Questionnaire-15 item (TYDQ-15), which consists of 15 items related to 5 factors: healthy thinking, meaningful activities, goals and plans, healthy habits, and social connections on a 5-point Likert scale ranging from 0-4. Scores are summed into subscale scores ranging from 0 to 12, and a total score ranging from 0 to 60, with higher scores indicating greater engagement in adaptive actions. Clients self-report how often they engaged in each activity in the last week.

  Baseline (Screening), weeks 4, 6 (post treatment) and 18 post enrollment

Secondary Outcomes (10)

• Changes in Alcohol Craving

  Baseline(Screening), weeks 6 (post treatment) and 18 post enrollment

• Change in Alcohol Use Disorder Identification Test Scores

  Baseline(Screening), weeks 6 (post-treatment) and 18 (follow up)

• Changes in Depression

  Baseline (Screening), weeks 1, 4, 6 (post treatment) and 18 week post enrollment

• Changes in Anxiety

  Baseline (Screening), weeks 6 and 18 post enrollment

• Change in Anger

  Baseline (Screening), weeks 6 and 18 post enrollment

Other Outcomes (9)

• Background Information

  Baseline (Screening)

• Drug Use

  Baseline(Screening)

• Motivation for Change

  Baseline (Screening)

Study Arms (1)

ICBT for Alcohol Misuse

EXPERIMENTAL

Internet-delivered cognitive behavioral therapy for alcohol misuse.

Behavioral: Alcohol Change Course Enhanced

Interventions

Alcohol Change Course Enhanced BEHAVIORAL

The Alcohol Change Course Enhanced is an adaptation of the Alcohol Change Course, originally developed and evaluated in Switzerland. The Course is a six-lesson ICBT intervention delivered over eight weeks to individuals who self-report alcohol misuse. Due to therapist registration and availability, eligible clients residing in Saskatchewan will be offered the option of receiving therapist assistance (or not) alongside the Course, while clients from other Canadian provinces will not receive therapist support. In addition to the monitoring of weekly measures available to all clients, those receiving therapist support will receive weekly secure messaging from their assigned therapist for eight weeks. Therapists will spend approximately 15 minutes per week/per client receiving therapist support. Phone calls will be used in the event that there is a significant clinical issue requiring therapist attention that cannot be addressed over messaging (e.g., sudden increase in symptoms).

ICBT for Alcohol Misuse

Eligibility Criteria

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

You may qualify if:

• Be a resident of Canada
• Be 18 years or older
• Have access to a computer or appropriate device and the internet
• Endorse alcohol misuse

You may not qualify if:

• Current severe medical or psychiatric problem that requires immediate or alternate treatment (e.g. current and recent mania or psychosis requiring hospitalization, actively suicidal and unable to keep themselves safe, medical condition requiring immediate surgery or other invasive treatment, severe substance use, severe cognitive impairment);
• Currently receiving or expecting to receive individual alcohol treatment more than twice per month
• Other treatment in our clinic
• Unable to read and understand English. (All content is provided in English and staff is English speaking; it is cost prohibitive at this time to provide the complete service in languages other than English)

Sponsors & Collaborators

• University of Regina: lead
• Karolinska Institutet: collaborator
• Macquarie University, Australia: collaborator
• York University: collaborator

Study Sites (1)

Online Therapy Unit

Regina, Saskatchewan, S4S0A2, Canada

RECRUITING

MeSH Terms

Interventions

Ethanol

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Heather Hadjistavropoulos, PhD

  University of Regina

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marcie Nugent, MSW

CONTACT

306-337-3331; marcie.nugent@uregina.ca

Heather Hadjistavropoulos, PhD

CONTACT

306-585-5133; heather.hadjistavropoulos@uregina.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 13, 2025
• Study Start: May 14, 2025
• Primary Completion (Estimated): May 14, 2026
• Study Completion (Estimated): May 14, 2026
• Last Updated: August 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)