Alcohol Drinking Clinical Trial
Official title:
A Stepped-Care Approach for General Practice Patients With Alcohol Use Disorders
Verified date | October 2006 |
Source | University of Luebeck |
Contact | n/a |
Is FDA regulated | No |
Health authority | Germany: Ethics Commission |
Study type | Interventional |
In a randomized controlled trial, patients recruited in general practices and fulfilling criteria for alcohol dependence, alcohol abuse, at-risk drinking or binge drinking will be allocated to three conditions: (1) Stepped Care intervention (SC): up to 4 interventions depending on the success of the previous intervention (assessed by alcohol consumption and self-efficacy) which start with a minimal intervention (written feedback and manuals) and are followed by more intensive interventions (counseling) in case of no success, (2) Fixed Care intervention (FC): A fixed number of counseling sessions plus written feedback and manuals, and (3) a control group (CG) booklet on health behavior. Outcome assessment will be conducted in all three groups after 12 months. The hypothesis is that SC and FC do not differ in effectiveness but SC is more economic.
Status | Completed |
Enrollment | 450 |
Est. completion date | June 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 64 Years |
Eligibility |
Inclusion Criteria: - Alcohol dependence - Alcohol abuse - At-risk drinking - Binge drinking Exclusion Criteria: - Current treatment for alcohol problems |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Luebeck | German Federal Ministry of Education and Research |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduced alcohol consumption | |||
Secondary | Readiness to change drinking behavior |
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