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Alcohol MisuseNCT07021053

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

A study testing Alcohol Change Course Enhanced in people with Alcohol Misuse, run by University of Regina at 1 site in Canada.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Alcohol Misuse
What is being tested?
Alcohol Change Course Enhanced
Could I receive a placebo?
No, everyone receives an active treatment
How many people
165 participants
Where
1 siteCanada
Study dates
14 May 2025to 14 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Marcie Nugent, MSW contact

306-337-3331

marcie.nugent@uregina.ca

Heather Hadjistavropoulos, PhD contact

306-585-5133

heather.hadjistavropoulos@uregina.ca

Canada1 site, 1 recruiting
  • Online Therapy Unit

    Regina, Saskatchewan, S4S0A2

    Marcie Nugent, MSW, 306-337-3331, marcie.nugent@uregina.ca

    Heather Hadjistavropoulos, PhD, 306-585-5133, heather.hadjistavropoulos@uregina.ca

    Recruiting

Other trials in Canada

About this study

Official title: 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.

Read the 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.

Conditions
Alcohol Misuse
Being tested
Alcohol Change Course Enhanced
Keywords
Internet-delivered cognitive behaviour therapy, Alcohol misuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Alcohol Change Course EnhancedBehavioural

    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).

Study groups in NCT07021053
Study groupRoleWhat they receive
ICBT for Alcohol MisuseExperimentalInternet-delivered cognitive behavioral therapy for alcohol misuse.
Receives: Behavioral: Alcohol Change Course Enhanced

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

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

  2. 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.

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

Secondary outcomes (10)
  1. Changes in Alcohol Craving

    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.

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

  2. Change in Alcohol Use Disorder Identification Test Scores

    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.

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

  3. Changes in Depression

    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.

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

  4. Changes in Anxiety

    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.

    Measured: Baseline (Screening), weeks 6 and 18 post enrollment

  5. Change in Anger

    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.

    Measured: Baseline (Screening), weeks 6 and 18 post enrollment

  6. Changes in Loneliness

    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.

    Measured: Baseline (Screening), weeks 6 and 18 post enrollment

  7. Changes in Relationship Functioning

    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.

    Measured: Baseline(Screening), weeks 6 and 18 post enrollment

  8. Changes in Functioning

    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.

    Measured: Baseline(Screening), weeks 6 and 18 week post enrollment

  9. Changes in Treatment Credibility and Expectancy

    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.

    Measured: Baseline (Screening), weeks 3 and 6 post treatment.

  10. Structured Interview

    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.

    Measured: Week 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2025
  2. Study start14 May 2025
  3. Primary completion14 May 2027 (estimated)
  4. Study completion14 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
165 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07021053
Sponsor's protocol ID
2022-082b
Status last verified
Nov 2026
First submitted
5 Jun 2025
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Alcohol Change Course Enhanced in people with Alcohol Misuse, run by University of Regina at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marcie Nugent, MSW (306-337-3331, marcie.nugent@uregina.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Alcohol Consumption (time frame: Baseline (Screening), weeks 4, 6 (post-treatment) and 18 post enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

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