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

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

Detailed Description
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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.

Official Title
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Internet-based vs Face-to-face Treatment for Alcohol Dependence: A Randomised, Controlled Non-inferiority Trial

Conditions
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Alcohol Abuse, Alcohol Dependence, Harmful Alcohol Use, Alcohol Use Disorder

Intervention / Treatment
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* Behavioral: Guide to better alcohol habits


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: AUDIT-score ≥16 points and/or fulfilling at least 3 criteria of alcohol dependence (ICD-10) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-based treatment<br>Guide to better alcohol habits online. An Internet-based treatment program with online counselor support. | Behavioral: Guide to better alcohol habits<br>* A 5-module therapeutic program wich includes self-help material in printed or web-based form with interactive exercises. The program includes instructions for the therapist.<br>* Other names: eChange;|
| Experimental: Face-to-face treatment<br>Guide to better alcohol habits F2F: Face-to-face treatment with 5 individual counselor sessions at the clinic. | Behavioral: Guide to better alcohol habits<br>* A 5-module therapeutic program wich includes self-help material in printed or web-based form with interactive exercises. The program includes instructions for the therapist.<br>* Other names: eChange;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Line Follow Back (TLFB) | Change in number of standard drinks per day during last 7 days | 3, 6, 12 and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time Line Follow Back (TLFB) Change in number of consumption days | Change in number of drinking days during last 7 days | 3, 6, 12 and 24 months | 
| Time Line Follow Back (TLFB) Change in number of days binge-drinking days | Change in number of binge-drinking days during last 7 days | 3, 6, 12 and 24 months | 
| Alcohol Use Disorders Identification Test Consumption (AUDIT-C) | Change in Quantity, Frequency and Binge-drinking scores during the time since last reported | 3, 6, 12 and 24 months | 
| Alcohol Use Disorders Identification Test (AUDIT) | Change in total AUDIT score, as a summarized measure of alcohol use since last reported | 3, 6, 12 and 24 months | 
| Montgomery Asberg Depression Rating Scale - Self report (MADRS-S) | Change in total MADRS-S score, as a summarized measure of depression | 3, 6, 12 and 24 months | 
| Generalised Anxiety Disorder Assessment (GAD-7) | Change in total GAD-7 score, as a summarized measure of anxiety | 3, 6, 12 and 24 months | 
| Questions about help-seeking behavior from family and friends | 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 | 3, 6, 12 and 24 months | 
| Questions about help-seeking behavior from professionals | 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 | 3, 6, 12 and 24 months |