Internet-based vs Face-to-face Treatment for Alcohol Dependence

Not Applicable

Completed

• Conditions: Alcohol Dependence; Harmful Alcohol Use; Alcohol Use Disorder; Alcohol Abuse
• Interventions: Behavioral: Guide to better alcohol habits

• Registration Number: NCT02888002
• Lead Sponsor: Karolinska Institutet

Brief Summary

A brief treatment program (MI/CBT) via face-to-face or via internet is tested in association with an outpatient addictions clinic.

Detailed Description

A 5-module program based on motivational interviewing (MI) and cognitive behavioral therapy (CBT) is tested among help-seekers at one outpatient clinic within the Stockholm Center for Dependency Disorders: Riddargatan 1.The design is a two-armed randomized controlled non-inferiority study, and outcomes are measured in terms of changes in alcohol consumption, problematic alcohol use, alcohol dependence alcohol use disorder, anxiety, as well as depression and quality of life. 600 participants are recruited online from the clinic's website. Consenting participants will complete baseline questionnaires online and participate in face-to-face assessment by a physician at the clinic. Eligible individuals will then be randomized into one of two groups: 1.Internet-based treatment program with online counselor support. 2. Face-to-face treatment with 5 individual counselor sessions at the clinic. Follow-up will be conducted online after 3, 6, 12 and 24 months in both groups.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-12-01
• Study First Submitted: 2016-01-17
• Study First Submitted QC: 2016-08-29
• Study First Posted: 2016-09-02
• Primary Completion: 2020-03-30
• Study Completion: 2020-03-30
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-01
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 310

Inclusion Criteria

• AUDIT-score ≥16 points and/or fulfilling at least 3 criteria of alcohol dependence (ICD-10)

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Exclusion Criteria

• Risk of severe withdrawal symptoms.
• Risk of suicide.
• Other psychiatric diagnosis that requires current treatment.
• Need for medication for alcohol dependence.
• Inadequate Swedish language skills.
• No Internet access

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Face-to-face treatment	Guide to better alcohol habits	"Guide to better alcohol habits F2F": Face-to-face treatment with 5 individual counselor sessions at the clinic.
Internet-based treatment	Guide to better alcohol habits	"Guide to better alcohol habits online". An Internet-based treatment program with online counselor support.

Primary Outcome Measures

Name	Time	Method
Time Line Follow Back (TLFB)	3, 6, 12 and 24 months	Change in number of standard drinks per day during last 7 days

Secondary Outcome Measures

Name	Time	Method
Time Line Follow Back (TLFB) Change in number of consumption days	3, 6, 12 and 24 months	Change in number of drinking days during last 7 days
Alcohol Use Disorders Identification Test Consumption (AUDIT-C)	3, 6, 12 and 24 months	Change in Quantity, Frequency and Binge-drinking scores during the time since last reported
Montgomery Asberg Depression Rating Scale - Self report (MADRS-S)	3, 6, 12 and 24 months	Change in total MADRS-S score, as a summarized measure of depression
Questions about help-seeking behavior from professionals	3, 6, 12 and 24 months	Change in help-seeking for alcohol related problems from professionals. The questions about "other forms of support and treatment for problematic alcohol use during the trial period" were developed by our research group and used in a previous study of ours: Berman, A. H., Wennberg, P., \& Sinadinovic, K. (2015). Changes in Mental and Physical Well-Being Among Problematic Alcohol and Drug Users in 12-Month Internet-Based Intervention Trials. Psychology of Addictive Behaviors, 29(1), 97-105. doi:10.1037/a0038420.PMID:25664387
Questions about help-seeking behavior from family and friends	3, 6, 12 and 24 months	Change in help-seeking for alcohol related problems from family and friends. The questions about "other forms of support and treatment for problematic alcohol use during the trial period" were developed by our research group and used in a previous study of ours: Berman, A. H., Wennberg, P., \& Sinadinovic, K. (2015). Changes in Mental and Physical Well-Being Among Problematic Alcohol and Drug Users in 12-Month Internet-Based Intervention Trials. Psychology of Addictive Behaviors, 29(1), 97-105. doi:10.1037/a0038420.PMID:25664387
Generalised Anxiety Disorder Assessment (GAD-7)	3, 6, 12 and 24 months	Change in total GAD-7 score, as a summarized measure of anxiety
Time Line Follow Back (TLFB) Change in number of days binge-drinking days	3, 6, 12 and 24 months	Change in number of binge-drinking days during last 7 days
Alcohol Use Disorders Identification Test (AUDIT)	3, 6, 12 and 24 months	Change in total AUDIT score, as a summarized measure of alcohol use since last reported

Trial Locations

Locations (1)

Karolinska Institutet, Department of Public Health Sciences; 🇸🇪 Stockholm, Sweden