Clinical trial NCT04611854: Internet-delivered Therapy for Alcohol Misuse: Investigating Patient Preference for Self-guided or Guided Treatment
Official title: Internet-delivered Therapy for Alcohol Misuse: Engagement, Outcomes and Satisfaction When Patients Select Preference for Self-guided or Guided Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: Internet-delivered Cognitive Behaviour Therapy
Guidance
Alcohol Misuse
Lead sponsor: University of Regina
Sponsor class: OTHER
Collaborators: name: Saskatchewan Centre for Patient-Oriented Research
name: Saskatchewan Health Research Foundation
name: Ministry of Health, Saskatchewan
First posted: 2020-11-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Each client will select either self-guided or guided option.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Drinks in preceding week as measured by Timeline Followback (TLFB)
timeFrame: Screening, Pre-treatment, 4 weeks (mid-treatment), 8 weeks (post-treatment), 3 months after treatment
measure: Heavy drinking days preceding week as measured by Timeline Followback (TLFB)
timeFrame: Screening, Pre-treatment, 4 weeks (mid-treatment), 8 weeks (post-treatment), 3 months after treatment
Secondary outcomes:
measure: Alcohol Use Disorders Identification Test (AUDIT)
timeFrame: Screening, 8 weeks (post-treatment), 3 months after treatment
measure: Penn Alcohol Craving Scale
timeFrame: Screening, 8 weeks (post-treatment), 3 months after treatment, 6 months after treatment, 12 months after treatment
measure: Brief Situational Confidence Questionnaire (BSCQ)
timeFrame: Screening, 8 weeks (post-treatment), 3 months after treatment
measure: Generalized Anxiety Disorder 7-item (GAD-7)
timeFrame: Screening, 8 weeks (post-treatment), 3 months after treatment
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Screening (Pre-treatment), 4 weeks (mid-treatment), 8 weeks (post-treatment), 3 months after treatment
measure: Sheehan Disability Scale
timeFrame: Screening, 8 weeks (post-treatment), 3 months after treatment
measure: Treatment Credibility and Expectancy Scale
timeFrame: 4 weeks (mid-treatment)
measure: Readiness to Change Questionnaire Treatment Version (RCQ-TV)
timeFrame: Screening (Pre-treatment)
measure: Evaluation and Negative Effects Questionnaire
timeFrame: 8 weeks (post-treatment)
measure: Lesson Completion
timeFrame: Ongoing throughout treatment (Weeks 1-8)
Other outcomes:
Locations:
city: Regina
country: Canada
facility: Online Therapy Unit, University of Regina
state: Saskatchewan
Study officials:
affiliation: University of Regina
name: Heather Hadjistavropoulos, PhD
role: PRINCIPAL_INVESTIGATOR
References: