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

August 15, 2025 updated by: University of Regina

Adaptive Actions and Alcohol Use Outcomes During Internet-delivered Cognitive Behaviour Therapy: An Observational Study During Routine Care

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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. 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. 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. 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. 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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
165

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Saskatchewan
      • Regina, Saskatchewan, Canada, S4S0A2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ICBT for Alcohol Misuse
Internet-delivered cognitive behavioral therapy for alcohol misuse.
Behavioral: Alcohol Change Course Enhanced
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in Alcohol Consumption
Time Frame: 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).
Baseline (Screening), weeks 4, 6 (post-treatment) and 18 post enrollment
Changes in Adaptive Actions
Time Frame: 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.
Baseline (Screening), weeks 4, 6 (post treatment) and 18 post enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Alcohol Craving
Time Frame: 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.
Baseline(Screening), weeks 6 (post treatment) and 18 post enrollment
Change in Alcohol Use Disorder Identification Test Scores
Time Frame: 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.
Baseline(Screening), weeks 6 (post-treatment) and 18 (follow up)
Changes in Depression
Time Frame: 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.
Baseline (Screening), weeks 1, 4, 6 (post treatment) and 18 week post enrollment
Changes in Anxiety
Time Frame: 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.
Baseline (Screening), weeks 6 and 18 post enrollment
Change in Anger
Time Frame: 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.
Baseline (Screening), weeks 6 and 18 post enrollment
Changes in Loneliness
Time Frame: 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.
Baseline (Screening), weeks 6 and 18 post enrollment
Changes in Relationship Functioning
Time Frame: 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.
Baseline(Screening), weeks 6 and 18 post enrollment
Changes in Functioning
Time Frame: 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.
Baseline(Screening), weeks 6 and 18 week post enrollment
Changes in Treatment Credibility and Expectancy
Time Frame: 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.
Baseline (Screening), weeks 3 and 6 post treatment.
Structured Interview
Time Frame: 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.
Week 3

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Background Information
Time Frame: Baseline (Screening)
Background information including demographic questions will be collected at screening for descriptive purposes. No scores are calculated.
Baseline (Screening)
Drug Use
Time Frame: Baseline(Screening)
The Drug Use Disorder Identification Test-Concise (DUDIT-C) is a 4-item measure used to assess problematic drug use. Items are measured on a 5-point Likert scale ranging from 0-4, with total scores ranging from 0-16. Higher scores indicate more severe drug use problem.
Baseline(Screening)
Motivation for Change
Time Frame: Baseline (Screening)
Measure of clients' motivation for changing their alcohol use. Clients self-report the importance of changing their alcohol use, their confidence in their ability to change their alcohol use, and their readiness to change their alcohol use using 3 items. Each item is rated from 1-10, and scores are summed to produce a total score ranging from 3-30, with higher scores indicating higher motivation.
Baseline (Screening)
Changes in Alcohol Consumption in the Previous Week
Time Frame: Weeks 1-3, 5, 7, 8
Clients self-report how many total standard drinks they consumed in the previous week and the number of days they consumed alcohol using two questions. Standard drinks are defined as: one 12 oz (341 mL) can or bottle of 5% beer, cider, or cooler; one 4.5 oz (142 mL) glass of 12% wine; or one 1.3-1.5 oz (40-45 mL) shot of 40% distilled spirits. This measure is used by clinicians to assess alcohol consumption on weeks when the primary alcohol measures are not administered.
Weeks 1-3, 5, 7, 8
Alcohol Change Goal Questionnaire
Time Frame: Week 2 and 6 (post treatment)
Measures clients' goals related to their alcohol use with two or three open-ended questions depending on whether client's goal is to quit or cut down alcohol consumption or some other goal. These questions explore what the maximum number of drinks will be if client's goal is to cut down alcohol consumption, other goals client have during the course, and what would help them in achieving their goals. This questionnaire was developed by the research team and does not have a sum score.
Week 2 and 6 (post treatment)
Homework Reflection
Time Frame: Weeks 2, 3, 4, 5, 6(post treatment), 7, 8
A 5-item questionnaire assessing clients' week-to-week experiences in the ACCE, with items inquiring about the lesson participants worked on; effort exerted towards skills; helpfulness of lessons; and client successes, challenges and experiences over the previous week. A combination of checklist, Likert scale [7-point (1-7)], and open-ended response options are used to gauge participants' participation. This brief questionnaire has been developed by the research team and does not have a sum score.
Weeks 2, 3, 4, 5, 6(post treatment), 7, 8
Additional Resource Questions
Time Frame: Week 6(post-treatment)
Clients are asked about their opinions of and satisfaction with the additional resources that they have reviewed since the beginning of the ACCE using yes/no dichotomous, multiple choice, and Likert scale response option. This questionnaire was developed by the research team and does not have a total score.
Week 6(post-treatment)
Evaluation of Treatment
Time Frame: Week 6 (post-treatment)
A 12-item questionnaire used to assess satisfaction with treatment and negative effects experienced by clients during treatment. The questionnaire uses a combination of Likert-scale [5-point (0-4) and 6-point (0-5)], open-ended, and dichotomous yes/no response options to gauge participants' perceptions of the course. The questionnaire has been developed by the research team. A total score is not produced for this measure.
Week 6 (post-treatment)
Other Forms of Help
Time Frame: Week 6 (post-treatment) and 18 post-enrollment
Examines other types of help that clients received during treatment. This questionnaire has been developed by the research team and does not have a sum score.
Week 6 (post-treatment) and 18 post-enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Regina

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Karolinska Institutet
York University
Macquarie University, Australia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Heather Hadjistavropoulos, PhD, University of Regina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 14, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 14, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 14, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 5, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 13, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022-082b

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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