Alcohol Drinking Clinical Trial
Official title:
Randomized Controlled Trial of a Expert System for Patients With At-risk Drinking, Alcohol Abuse and Alcohol Dependence in General Hospital
Verified date | April 2014 |
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 a general hospital and fulfilling
criteria for alcohol dependence, alcohol abuse or at-risk drinking will be randomly
allocated to two conditions:(1) Transtheoretical Model (TTM)-based expert system group,
patients receive an individualized feedback on drinking norms, health-related risks and core
constructs of the TTM, augmented by a TTM-based manual, (2) Control group,receiving a
booklet on health behavior.
Outcome assessment will be conducted after 12 months. The hypothesis is that individualized
feedback leads to greater reduction in alcohol consumption and elevated readiness to change
at follow-up.
Status | Completed |
Enrollment | 347 |
Est. completion date | November 2006 |
Est. primary completion date | November 2005 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 64 Years |
Eligibility |
Inclusion Criteria: - Alcohol Abuse - Alcohol Dependence - At-risk drinking Exclusion Criteria: - Current treatment for alcohol problems - Terminal illness |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Germany | University of Luebeck, Dpt. of Psychiatry and Psychotherapy | Luebeck |
Lead Sponsor | Collaborator |
---|---|
University of Luebeck | German Federal Ministry of Education and Research |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Average alcohol consumption (QF) gr/alc. per day | Main outcome is reduction in daily average alcohol consumption, operationalized by a Quantity-/Frequency measure | 12 months | No |
Secondary | Readiness to change drinking behavior | Readiness to change questionnaire | 12 months | No |
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