Internet-based vs Face-to-face Treatment for Alcohol Dependence: A Randomised, Controlled Non-inferiority Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Alcohol Abuse
- Sponsor
- Karolinska Institutet
- Enrollment
- 310
- Locations
- 1
- Primary Endpoint
- Time Line Follow Back (TLFB)
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Anne H Berman
Associate Professor
Karolinska Institutet
Eligibility Criteria
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
Outcomes
Primary Outcomes
Time Line Follow Back (TLFB)
Time Frame: 3, 6, 12 and 24 months
Change in number of standard drinks per day during last 7 days
Secondary Outcomes
- Time Line Follow Back (TLFB) Change in number of consumption days(3, 6, 12 and 24 months)
- Alcohol Use Disorders Identification Test Consumption (AUDIT-C)(3, 6, 12 and 24 months)
- Montgomery Asberg Depression Rating Scale - Self report (MADRS-S)(3, 6, 12 and 24 months)
- Questions about help-seeking behavior from professionals(3, 6, 12 and 24 months)
- Questions about help-seeking behavior from family and friends(3, 6, 12 and 24 months)
- Generalised Anxiety Disorder Assessment (GAD-7)(3, 6, 12 and 24 months)
- Time Line Follow Back (TLFB) Change in number of days binge-drinking days(3, 6, 12 and 24 months)
- Alcohol Use Disorders Identification Test (AUDIT)(3, 6, 12 and 24 months)