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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04611854
Enrollment
80
Registered
2020-11-02
Start date
2020-11-01
Completion date
2022-08-19
Last updated
2023-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Use Disorder

Keywords

Internet-delivered Cognitive Behaviour Therapy, Guidance, Alcohol Misuse

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.

Interventions

BEHAVIORALGuidance

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.

The 8-week internet-delivered cognitive behaviour therapy (ICBT) course for alcohol misuse. The course consists of 8 lessons distributed across 8 weeks.

Sponsors

Saskatchewan Centre for Patient-Oriented Research
CollaboratorOTHER
Saskatchewan Health Research Foundation
CollaboratorOTHER
Ministry of Health, Saskatchewan
CollaboratorOTHER
University of Regina
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Each client will select either self-guided or guided option.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Drinks in preceding week as measured by Timeline Followback (TLFB)Screening, Pre-treatment, 4 weeks (mid-treatment), 8 weeks (post-treatment), 3 months after treatmentChange in preceding week alcohol consumption in terms of the total number of standard drinks consumed on each day during the previous 7 days.
Heavy drinking days preceding week as measured by Timeline Followback (TLFB)Screening, Pre-treatment, 4 weeks (mid-treatment), 8 weeks (post-treatment), 3 months after treatmentChange in preceding week alcohol consumption in terms of the total number of heavy drinking days during the previous 7 days.

Secondary

MeasureTime frameDescription
Brief Situational Confidence Questionnaire (BSCQ)Screening, 8 weeks (post-treatment), 3 months after treatmentChange 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.
Generalized Anxiety Disorder 7-item (GAD-7)Screening, 8 weeks (post-treatment), 3 months after treatmentChange in total GAD-7 anxiety score which can range from 0 to 21. Higher scores indicate greater anxiety (worse outcome).
Patient Health Questionnaire (PHQ-9)Screening (Pre-treatment), 4 weeks (mid-treatment), 8 weeks (post-treatment), 3 months after treatmentChange in total PHQ-9 score which can range from 0 to 27. Higher scores indicate greater depression (worse outcome).
Sheehan Disability ScaleScreening, 8 weeks (post-treatment), 3 months after treatmentChange 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.
Alcohol Use Disorders Identification Test (AUDIT)Screening, 8 weeks (post-treatment), 3 months after treatmentChange 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)
Readiness to Change Questionnaire Treatment Version (RCQ-TV)Screening (Pre-treatment)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).
Evaluation and Negative Effects Questionnaire8 weeks (post-treatment)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.
Lesson CompletionOngoing throughout treatment (Weeks 1-8)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.
Treatment Credibility and Expectancy Scale4 weeks (mid-treatment)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.
Penn Alcohol Craving ScaleScreening, 8 weeks (post-treatment), 3 months after treatment, 6 months after treatment, 12 months after treatmentChange in alcohol craving as measured by a total score ranging between 0 to 30. Higher scores indicate greater craving (worse outcome).

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 8, 2026