Adaptive Actions and Alcohol Use Outcomes During Internet-delivered Cognitive Behaviour Therapy
ConditionAlcohol Misuse
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Regina
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Be a resident of Canada
Be 18 years or older
Have access to a computer or appropriate device and the internet
Endorse alcohol misuse
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
Alcohol Change Course Enhanced
BehavioralThe 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).
Treatment groups
165 Participants
are divided into 1 treatment groupGroup A: ICBT for Alcohol MisuseExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
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).
Time frame
Baseline (Screening), weeks 4, 6 (post-treatment) and 18 post enrollment2
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.
Time frame
Baseline (Screening), weeks 4, 6 (post treatment) and 18 post enrollmentSecondary outcomes
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.
Time frame
Baseline(Screening), weeks 6 (post treatment) and 18 post enrollment2
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.
Time frame
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.
Time frame
Baseline (Screening), weeks 1, 4, 6 (post treatment) and 18 week post enrollment4
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.
Time frame
Baseline (Screening), weeks 6 and 18 post enrollmentOther outcomes
1
Background Information
Background information including demographic questions will be collected at screening for descriptive purposes. No scores are calculated.
Time frame
Baseline (Screening)2
Drug Use
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.
Time frame
Baseline(Screening)3
Motivation for Change
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.
Time frame
Baseline (Screening)4
Changes in Alcohol Consumption in the Previous Week
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.
Time frame
Weeks 1-3, 5, 7, 8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Regina
Lead sponsor
Karolinska Institutet
Collaborator
Macquarie University, Australia
Collaborator
York University
Collaborator
Source ClinicalTrials.gov