Clinical trial NCT07021053: Adaptive Actions and Alcohol Use Outcomes During Internet-delivered Cognitive Behaviour Therapy
Official title: Adaptive Actions and Alcohol Use Outcomes During Internet-delivered Cognitive Behaviour Therapy: An Observational Study During Routine Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Alcohol Misuse
Keywords: Internet-delivered cognitive behaviour therapy
Alcohol misuse
Lead sponsor: University of Regina
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
name: Macquarie University, Australia
name: York University
First posted: 2025-06-13
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Changes in Alcohol Consumption
timeFrame: Baseline (Screening), weeks 4, 6 (post-treatment) and 18 post enrollment
measure: Changes in Adaptive Actions
timeFrame: Baseline (Screening), weeks 4, 6 (post treatment) and 18 post enrollment
Secondary outcomes:
measure: Changes in Alcohol Craving
timeFrame: Baseline(Screening), weeks 6 (post treatment) and 18 post enrollment
measure: Change in Alcohol Use Disorder Identification Test Scores
timeFrame: Baseline(Screening), weeks 6 (post-treatment) and 18 (follow up)
measure: Changes in Depression
timeFrame: Baseline (Screening), weeks 1, 4, 6 (post treatment) and 18 week post enrollment
measure: Changes in Anxiety
timeFrame: Baseline (Screening), weeks 6 and 18 post enrollment
measure: Change in Anger
timeFrame: Baseline (Screening), weeks 6 and 18 post enrollment
measure: Changes in Loneliness
timeFrame: Baseline (Screening), weeks 6 and 18 post enrollment
measure: Changes in Relationship Functioning
timeFrame: Baseline(Screening), weeks 6 and 18 post enrollment
measure: Changes in Functioning
timeFrame: Baseline(Screening), weeks 6 and 18 week post enrollment
measure: Changes in Treatment Credibility and Expectancy
timeFrame: Baseline (Screening), weeks 3 and 6 post treatment.
measure: Structured Interview
timeFrame: Week 3
Other outcomes:
measure: Background Information
timeFrame: Baseline (Screening)
measure: Drug Use
timeFrame: Baseline(Screening)
measure: Motivation for Change
timeFrame: Baseline (Screening)
measure: Changes in Alcohol Consumption in the Previous Week
timeFrame: Weeks 1-3, 5, 7, 8
measure: Alcohol Change Goal Questionnaire
timeFrame: Week 2 and 6 (post treatment)
measure: Homework Reflection
timeFrame: Weeks 2, 3, 4, 5, 6(post treatment), 7, 8
measure: Additional Resource Questions
timeFrame: Week 6(post-treatment)
measure: Evaluation of Treatment
timeFrame: Week 6 (post-treatment)
measure: Other Forms of Help
timeFrame: Week 6 (post-treatment) and 18 post-enrollment
Locations:
city: Regina
country: Canada
facility: Online Therapy Unit
state: Saskatchewan
Study officials:
affiliation: University of Regina
name: Heather Hadjistavropoulos, PhD
role: PRINCIPAL_INVESTIGATOR
References: