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

Not Applicable

Recruiting

• Conditions: Alcohol Misuse

• Registration Number: NCT07021053
• Lead Sponsor: University of Regina

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.

Detailed Description

Internet-delivered Cognitive Behaviour Therapy (ICBT) is an effective intervention for a variety of psychological concerns, including alcohol misuse. In ICBT, clients access structured online content (e.g., lessons, worksheets), similar to the therapeutic content that is delivered in face-to-face cognitive behaviour therapy. ICBT can be offered with or without brief therapist support, which often involves the use of secure messaging. Past research shows that ICBT for alcohol misuse is effective both when self-guided and therapist-guided. Previous studies of an ICBT course for alcohol misuse (the Alcohol Change Course Enhanced) by the Online Therapy Unit found that clients report large reductions in weekly alcohol consumption and heavy drinking days (Hadjistavropoulos et al., 2025). Further, clients report significant reductions in symptoms of anxiety and depression, cravings, risky or hazardous alcohol consumption, anger, PTSD, insomnia, and work and social adjustment.

An important body of work has demonstrated that individuals' thoughts and daily actions have a significant impact on their psychological health (Keyes et al., 2002; Ryff et al., 1989; Seligman et al., 2018). The Things You Do Questionnaire (TYDQ) was developed to capture the adaptive (i.e., helpful) actions most strongly associated with psychological health including: Healthy Thinking, Meaningful Activities, Goals and Plans, Healthy Habits, and Social Connections (Titov et al., 2022). Research shows that those who engage in the identified actions at least half of the days of the week report lower symptoms of depression and anxiety, and conversely, increased satisfaction with life. Subsequent research has shown that the frequency of these actions change during ICBT for depression and anxiety (Bisby et al., 2022, 2023). Specifically, the frequency of adaptive actions increases across treatment, and increases in adaptive actions mirrors the decreases in depressive and anxiety symptoms over time.

For clients with alcohol misuse, the investigators assume that as these clients reduce alcohol use, they will also increase engagement in these behaviors that are known to be associated with psychological health, but this has not yet been systematically examined during ICBT. Engagement in adaptive actions may also help prevent relapse, such that if clients increase adaptive actions, they may be more likely to maintain reductions in alcohol use.

Of note, within the Online Therapy Unit, the ICBT for alcohol misuse program addresses TYD within the current treatment materials at various points. In the recent revision of the course, the investigators have highlighted how these actions are helpful for reducing alcohol use and are also associated with psychological health.

Lesson 1 - Provides alcohol psycho education and explains 5 Things You Do as helpful activities; highlights how Goal Setting is helpful for alcohol reduction and improving psychological health; Lesson 2 - Provides information on risk situations and seemingly unimportant decisions; highlights how Engaging in Meaningful Activities and Healthy Routines is helpful for alcohol reduction and improving psychological health; Lesson 3 - Discusses saying no and coping with cravings; highlights how Social Connection is helpful for alcohol reduction and improving psychological health; Lesson 4 - Discusses thought challenging; highlights how Healthy Thinking is helpful for alcohol reduction and improving psychological health; Lesson 5 - Discusses problem solving; highlights how Social Connection is helpful for alcohol reduction and improving psychological health; Lesson 6 - Discusses relapse prevention and planning for the future; highlights the importance of Goal Setting as helpful for alcohol reduction longer term and improving psychological health.

The primary aim of the current study will be to extend research on the TYD to ICBT for alcohol misuse. The investigators will explore the relationship between alcohol use and adaptive actions at pre-treatment and if the frequency of adaptive actions increases as alcohol problems improve. Observational data will be collected at pre-treatment, mid-treatment, post-treatment, and follow-up as part of routine care at the Online Therapy Unit, funded by the Saskatchewan government to provide ICBT to Saskatchewan residents. Saskatchewan clients who meet eligibility criteria will indicate their preference for the therapist-guided or self-guided (with monitoring) ACCE. Clients from other provinces in Canada will be offered self-guided ACCE only. Findings from this study may inform future enhancements to ICBT for alcohol misuse.

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-05-14
• Study First Submitted: 2025-06-05
• Study First Submitted QC: 2025-06-05
• Last Update Submitted: 2025-06-05
• Study First Posted: 2025-06-13
• Last Update Posted: 2025-06-13
• Primary Completion: 2026-05-14
• Study Completion: 2026-05-14

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 165

Inclusion Criteria

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

Exclusion Criteria

• 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Changes in Alcohol Consumption	Baseline (Screening), weeks 4, 6 (post-treatment) and 18 post enrollment	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).
Changes in Adaptive Actions	Baseline (Screening), weeks 4, 6 (post treatment) and 18 post enrollment	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.

Secondary Outcome Measures

Name	Time	Method
Changes in Alcohol Craving	Baseline(Screening), weeks 6 (post treatment) and 18 post enrollment	Measured using the Penn Alcohol Cravings Scale. 5 items are measured on a 7-point Likert scale ranging from 0-6. Scores are summed into a total score ranging from 0 to 30. Higher scores indicate greater alcohol cravings.
Change in Alcohol Use Disorder Identification Test Scores	Baseline(Screening), weeks 6 (post-treatment) and 18 (follow up)	The Alcohol Use Disorder Identification Test (AUDIT) is a10-item screening tool to assess for problematic alcohol use. The first eight items are measured on a 5-point Likert scale ranging from 0-4, while the last two items are measured on a 3-point Likert scale ranging from 0-4. 10 items are summed to produce a total score ranging from 0 to 40, with higher scores indicating more severe alcohol use problems.
Changes in Depression	Baseline (Screening), weeks 1, 4, 6 (post treatment) and 18 week post enrollment	Measured using the Patient Health Questionnaire 9-item (PHQ-9). 9 items are measured on a 4-point Likert scale ranging from 0-3. Scores are summed for a total score ranging from 0 to 27. Higher scores indicate more severe depressive symptoms.
Changes in Anxiety	Baseline (Screening), weeks 6 and 18 post enrollment	Measured using the Generalized Anxiety Disorder 7-item (GAD-7). 7 items are measured on a 4-point Likert scale ranging from 0-3. Scores are summed to create a total score ranging from 0 to 21, with higher scores indicating more severe symptoms.
Change in Anger	Baseline (Screening), weeks 6 and 18 post enrollment	Measured using the Dimensions of Anger Reactions (DAR-5). 5 items are measured on a 5-point Likert scale ranging from 1-5. Scores are summed to produce a total score range from 5 to 25, with higher scores indicating greater severity of anger problems.
Changes in Loneliness	Baseline (Screening), weeks 6 and 18 post enrollment	Measured using the UCLA 3-Item Loneliness Scale, which includes self-report items that measure three dimensions of loneliness (i.e., relational connectedness, social connectedness, and self-perceived isolation). 3 items are measured on a 3-point Likert scale ranging from 1-3. Scores are summed into a total score ranging from 3 to 9, with higher scores indicating greater feelings of loneliness.
Changes in Relationship Functioning	Baseline(Screening), weeks 6 and 18 post enrollment	Measured using the Couples Satisfaction Index 4-item (CSI-4). The first item is measured on a 7-point Likert scale ranging from 0-6. The last three items are measured on a 6-point Likert scale ranging from 0-5. Scores are summed to produce a total score ranging from 0 to 21. Higher total scores indicate greater relationship satisfaction, with scores \<13.5 indicating notable dissatisfaction.
Structured Interview	Week 3	Email invitation will be sent to clients (until saturation is met) during week 2 for them to schedule an appointment for a telephone interview with a member of the research team. Interviews will focus on collecting information about client expectancy and credibility of the course.
Changes in Functioning	Baseline(Screening), weeks 6 and 18 week post enrollment	Measured using the 5-item Work and Social Adjustment Scale (WSAS). 5 items are measured on a 9-point Likert scale ranging from 0-8. Scores are summed into a total score range from 0 to 40, with higher scores indicating more severe impairment in functioning. Scores of 10 or higher indicate moderate impairment. Scores of 20 or higher indicate severe impairment.
Changes in Treatment Credibility and Expectancy	Baseline (Screening), weeks 3 and 6 post treatment.	Measured using the Credibility and Expectancy Questionnaire, which includes 6 items, with two subscales, to assess clients' beliefs about how credible and helpful a treatment will be for them. Each subscale contains 3-items. The three items of each subscale are measured on a 1-9 point Likert scale, with subscale scores ranging from 3 to 27. Higher scores in each sub-scale indicate greater treatment credibility or treatment expectancy respectively.

Trial Locations

Locations (1)

Online Therapy Unit; 🇨🇦 Regina, Saskatchewan, Canada