Internet-delivered Therapy for Alcohol Misuse: Investigating Patient Preference for Self-guided or Guided Treatment

Alcohol Use Disorder Clinical Trial

Official title:

Internet-delivered Therapy for Alcohol Misuse: Engagement, Outcomes and Satisfaction When Patients Select Preference for Self-guided or Guided Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04611854
• Other study ID #: 2019-058b
• Status: Completed
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: August 19, 2022

Study information

• Verified date: November 2023
• Source: University of Regina
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 19, 2022
• Est. primary completion date: August 19, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alcohol Use Disorder
• Alcoholism

Intervention

Behavioral:
• Guidance
Guidance from a health educator through regular weekly online messages. Participants may also be contacted through emails and phone calls. The team of guides consists of registered social workers, psychologists, and graduate students, with experience delivering ICBT.
• ICBT for alcohol misuse
The 8-week internet-delivered cognitive behaviour therapy (ICBT) course for alcohol misuse. The course consists of 8 lessons distributed across 8 weeks.

Locations

Country	Name	City	State
Canada	Online Therapy Unit, University of Regina	Regina	Saskatchewan

Sponsors (4)

Lead Sponsor	Collaborator
University of Regina	Ministry of Health, Saskatchewan, Saskatchewan Centre for Patient-Oriented Research, Saskatchewan Health Research Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Drinks in preceding week as measured by Timeline Followback (TLFB)	Change in preceding week alcohol consumption in terms of the total number of standard drinks consumed on each day during the previous 7 days.	Screening, Pre-treatment, 4 weeks (mid-treatment), 8 weeks (post-treatment), 3 months after treatment
Primary	Heavy drinking days preceding week as measured by Timeline Followback (TLFB)	Change in preceding week alcohol consumption in terms of the total number of heavy drinking days during the previous 7 days.	Screening, Pre-treatment, 4 weeks (mid-treatment), 8 weeks (post-treatment), 3 months after treatment
Secondary	Alcohol Use Disorders Identification Test (AUDIT)	Change in alcohol-related problems and behaviours measured by total AUDIT score which can range from 0 to 40. Greater score indicates greater alcohol problems (worse outcome)	Screening, 8 weeks (post-treatment), 3 months after treatment
Secondary	Penn Alcohol Craving Scale	Change in alcohol craving as measured by a total score ranging between 0 to 30. Higher scores indicate greater craving (worse outcome).	Screening, 8 weeks (post-treatment), 3 months after treatment, 6 months after treatment, 12 months after treatment
Secondary	Brief Situational Confidence Questionnaire (BSCQ)	Change in confidence in resisting drinking urges in 8 situations rated from 0 to 100, rendering a sum score of 0-800. Higher scores indicate greater confidence (better outcome). There are 8 subscales, one for each item, assessed on a scale of 0-100. Thus, each subscale has a sum score of 0-100-. A higher score indicates greater confidence on the subscale.	Screening, 8 weeks (post-treatment), 3 months after treatment
Secondary	Generalized Anxiety Disorder 7-item (GAD-7)	Change in total GAD-7 anxiety score which can range from 0 to 21. Higher scores indicate greater anxiety (worse outcome).	Screening, 8 weeks (post-treatment), 3 months after treatment
Secondary	Patient Health Questionnaire (PHQ-9)	Change in total PHQ-9 score which can range from 0 to 27. Higher scores indicate greater depression (worse outcome).	Screening (Pre-treatment), 4 weeks (mid-treatment), 8 weeks (post-treatment), 3 months after treatment
Secondary	Sheehan Disability Scale	Change in three scores assessing functional impairment in three domains: 1) work/school, 2) social and 3) family life (each domain score ranges from 0 to 10, rendering a sum score of 0-30). Higher score indicates greater ability on the specified domain score (better outcome). Each domain score (subscale) renders a sum score of 0-10.	Screening, 8 weeks (post-treatment), 3 months after treatment
Secondary	Treatment Credibility and Expectancy Scale	Measures the participant's thoughts and feelings about the treatment and the treatment's effectiveness in reducing participant's symptoms and increasing participant's functioning. Consists of 6 items. The first three of these and the 5th render a score of 1- 9. The other three questions render a score of 0-10. There are two subscales; 1) treatment credibility and 2) treatment expectancy. The first three questions are summed to render a score on the credibility subscale (0-27). The last three questions, the expectancy subscale, render a score of 0-29.	4 weeks (mid-treatment)
Secondary	Readiness to Change Questionnaire Treatment Version (RCQ-TV)	Measures participants' motivation to change their drinking behaviours and determines at which stage of the Stages of Change model they are in (precontemplation, contemplation, or action). There is no sum score. Instead the items related to each stage are summed, and the individual is allocated to the stage that has the greatest score out of these three. (For more information about the scoring of this instrument, see Heather & Hönekopp, 2009).	Screening (Pre-treatment)
Secondary	Evaluation and Negative Effects Questionnaire	This questionnaire will gather feedback from participants on perceived helpfulness and any negative effects experienced by participants during treatment. This brief questionnaire has been developed by the research team and does not have a sum score.	8 weeks (post-treatment)
Secondary	Lesson Completion	The program website will record when patients access each lesson, providing a way to calculate the proportion of patients who complete each lesson and treatment overall.	Ongoing throughout treatment (Weeks 1-8)