Internet-delivered Therapy for Alcohol Misuse: Engagement, Outcomes and Satisfaction When Patients Select Preference for Self-guided or Guided Treatment
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Regina
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Heavy drinking days preceding week as measured by Timeline Followback (TLFB)
Study Overview
Brief Summary
Internet-delivered cognitive behaviour therapy (ICBT) shows promise as a method of treating alcohol misuse. In this form of treatment, patients complete online lessons over several weeks that assist patients in developing skills to address alcohol misuse. ICBT can be offered to patients in a self-guided format or with guidance. Self-guided ICBT allows users to complete lessons by themselves without any contact with a guide. Guided ICBT involves having support from a guide in the form of emails, online messages and/or brief telephone calls. In some studies, guided-ICBT has shown greater reductions in alcohol consumption than self-guided ICBT. To date, there has been limited research on patient preferences for these varying levels of support when ICBT is offered as part of routine health care. This represents an important research direction as there is some past research showing that patients' treatment preferences can affect study enrollment, attrition, adherence, satisfaction, and outcomes.
This study will investigate patient preferences for self-guided ICBT versus guided-ICBT and compare enrollment, attrition, adherence, and outcomes of the two approaches when patients select their treatment preferences. The study will also explore the extent to which preferences are related to patient background variables (e.g., duration, severity of problems, treatment goals in terms of patients wanting to cut-down on alcohol use versus to abstain from alcohol use). Furthermore, this study seeks to identify how ratings of effort and helpfulness throughout treatment vary depending on whether patients select self-guided versus guided ICBT. This study represents a pragmatic observational trial conducted in routine care and aims to increase understanding of how to implement ICBT within routine care.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Timeline Followback (TLFB; preceding week alcohol consumption) > 13 drinks
- •Alcohol Use Disorders Identification Test (AUDIT) > 7
Exclusion Criteria
- •Suicidal ideation (measured by scoring > 2 to question 9 of PHQ-9)
- •Severe mental health or medical conditions
- •Severe drug use problems (measured by scoring > 24 on Drug Use Disorders Identification Test [DUDIT] or clinical assessment)
- •Low motivation to do, or concerns regarding, online treatment
- •Ongoing or impending significant mental health treatment
- •Not residing in Saskatchewan Canada for the duration of treatment
- •Lack of or inconsistent access to a computer and internet at home or private place for the duration of treatment
Outcomes
Primary Outcomes
Heavy drinking days preceding week as measured by Timeline Followback (TLFB)
Time Frame: Screening, Pre-treatment, 4 weeks (mid-treatment), 8 weeks (post-treatment), 3 months after treatment
Change in preceding week alcohol consumption in terms of the total number of heavy drinking days during the previous 7 days.
Drinks in preceding week as measured by Timeline Followback (TLFB)
Time Frame: Screening, Pre-treatment, 4 weeks (mid-treatment), 8 weeks (post-treatment), 3 months after treatment
Change in preceding week alcohol consumption in terms of the total number of standard drinks consumed on each day during the previous 7 days.
Secondary Outcomes
- Generalized Anxiety Disorder 7-item (GAD-7)(Screening, 8 weeks (post-treatment), 3 months after treatment)
- Alcohol Use Disorders Identification Test (AUDIT)(Screening, 8 weeks (post-treatment), 3 months after treatment)
- Lesson Completion(Ongoing throughout treatment (Weeks 1-8))
- Penn Alcohol Craving Scale(Screening, 8 weeks (post-treatment), 3 months after treatment, 6 months after treatment, 12 months after treatment)
- Patient Health Questionnaire (PHQ-9)(Screening (Pre-treatment), 4 weeks (mid-treatment), 8 weeks (post-treatment), 3 months after treatment)
- Evaluation and Negative Effects Questionnaire(8 weeks (post-treatment))
- Brief Situational Confidence Questionnaire (BSCQ)(Screening, 8 weeks (post-treatment), 3 months after treatment)
- Sheehan Disability Scale(Screening, 8 weeks (post-treatment), 3 months after treatment)
- Treatment Credibility and Expectancy Scale(4 weeks (mid-treatment))
- Readiness to Change Questionnaire Treatment Version (RCQ-TV)(Screening (Pre-treatment))