Internet-delivered Therapy for Alcohol Misuse: Investigating Patient Preference for Self-guided or Guided Treatment
1 other identifier
interventional
80
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 26, 2020
CompletedStudy Start
First participant enrolled
November 1, 2020
CompletedFirst Posted
Study publicly available on registry
November 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 19, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
August 19, 2022
CompletedDecember 4, 2023
November 1, 2023
1.8 years
October 26, 2020
November 30, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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 Outcomes (10)
Alcohol Use Disorders Identification Test (AUDIT)
Screening, 8 weeks (post-treatment), 3 months after treatment
Penn Alcohol Craving Scale
Screening, 8 weeks (post-treatment), 3 months after treatment, 6 months after treatment, 12 months after treatment
Brief Situational Confidence Questionnaire (BSCQ)
Screening, 8 weeks (post-treatment), 3 months after treatment
Generalized Anxiety Disorder 7-item (GAD-7)
Screening, 8 weeks (post-treatment), 3 months after treatment
Patient Health Questionnaire (PHQ-9)
Screening (Pre-treatment), 4 weeks (mid-treatment), 8 weeks (post-treatment), 3 months after treatment
- +5 more secondary outcomes
Study Arms (2)
ICBT for alcohol misuse: Guidance
ACTIVE COMPARATORIn this arm, participants will receive the 8-week internet-delivered cognitive behaviour therapy (ICBT) course for alcohol misuse with 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: Self-Guidance
EXPERIMENTALParticipants who select this arm will receive the 8-week internet-delivered cognitive behaviour therapy (ICBT) course for alcohol misuse. Participants are able to contact the Online Therapy Unit regarding any technical issues with logging onto the site. However, no guidance from a health educator will be provided. Clients will be monitored by providing brief measures on alcohol each week and measures of depression and anxiety administered at the beginning of week 5. However, clients will only be contacted if there is a significant clinical issue requiring attention (e.g., sudden increase in symptoms of depression and suicidal ideation).
Interventions
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.
Eligibility Criteria
You may qualify if:
- Timeline Followback (TLFB; preceding week alcohol consumption) \> 13 drinks
- Alcohol Use Disorders Identification Test (AUDIT) \> 7
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Reginalead
- Saskatchewan Centre for Patient-Oriented Researchcollaborator
- Saskatchewan Health Research Foundationcollaborator
- Ministry of Health, Saskatchewancollaborator
Study Sites (1)
Online Therapy Unit, University of Regina
Regina, Saskatchewan, S4S 0A2, Canada
Related Publications (1)
Sapkota RP, Lozinski T, Wilhems A, Nugent M, Schaub MP, Keough MT, Sundstrom C, Hadjistavropoulos HD. Internet-delivered therapy for alcohol misuse: engagement, satisfaction, and outcomes when patients select their preference for therapist- or self-guided treatment. Addict Sci Clin Pract. 2024 Apr 20;19(1):30. doi: 10.1186/s13722-024-00456-8.
PMID: 38643242DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heather Hadjistavropoulos, PhD
University of Regina
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 26, 2020
First Posted
November 2, 2020
Study Start
November 1, 2020
Primary Completion
August 19, 2022
Study Completion
August 19, 2022
Last Updated
December 4, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
- Time Frame
- Data will be available for a period beginning 6 months after the conclusion of the trial until 5 years have elapsed.
- Access Criteria
- Data will be provided to researchers who provide a methodologically sound proposal and present a request for data that is within our operational capacity to provide. Additionally, researchers must provide information about how they will use and store the data, as well as sign an agreement related to the use of the data.
Other researchers may ask to review IPD from this trial following completion of data collection. For the purposes of meta-analyses or other legitimate uses, IPD will be provided after being fully de-identified.