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Sponsors and Collaborators: |
University of Luebeck German Federal Ministry of Education and Research |
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Information provided by: | University of Luebeck |
ClinicalTrials.gov Identifier: | NCT00400010 |
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.
Condition | Intervention |
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Alcohol-Related Disorders Alcohol Drinking |
Behavioral: Brief intervention |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind, Placebo Control, Factorial Assignment, Efficacy Study |
Official Title: | Randomized Controlled Trial of a Expert System for Patients With at-Risk Drinking, Alcohol Abuse and Alcohol Dependence in General Hospital |
Estimated Enrollment: | 300 |
Study Start Date: | October 2004 |
Estimated Study Completion Date: | November 2006 |
Background: A promising approach in secondary prevention of problem drinking is to provide brief interventions in medical settings. However, brief interventions have not become implemented in general practices (GPs) due to insufficient role security and therapeutic commitment of physicians. Computerized expert systems can provide very cost-effective means of intervention and have been effective in the field of smoking cessation. However, in the alcohol field, research on this issue is scarce. Objectives: Comparing an expert system based on the Transtheoretical Model of behavior change for patients with at-risk drinking, alcohol abuse or alcohol dependence to a control condition. Methods: About 2,500 screenings among consecutive general hospital patients aged 18 to 64 will be conducted. Subjects fulfilling inclusion criteria (severe alcohol dependence excluded) will be randomly assigned to one of two conditions with 150 patients each: (1) In the 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) In the control group, participants receive a booklet on health behavior. Outcome assessment will be conducted after 12 months.
Outcome variables are alcohol consumption, stages of change progress and utilization of formal help. Expected impact: Findings are expected to provide evidence for a computerized TTM based expert system to be used in primary care. This would be the first international results confirming such an approach in the alcohol field. If a TTM-based expert system would be effective, this could significantly save resources and enhance secondary prevention. Therefore, data are of great public health interest. Relationship to the objective of the collaboration: As in the other studies, empirical data on new proactive approaches to reach underserved populations in the addiction field will be provided. The project will add knowledge on the economical use of interventions.
Ages Eligible for Study: | 18 Years to 64 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
University of Luebeck, Dpt. of Psychiatry and Psychotherapy | |
Luebeck, Germany, 23538 |
Principal Investigator: | Hans-Juergen Rumpf, Ph.D. | University of Luebeck |
Study ID Numbers: | 01EB0421-1 |
Study First Received: | November 14, 2006 |
Last Updated: | November 14, 2006 |
ClinicalTrials.gov Identifier: | NCT00400010 History of Changes |
Health Authority: | Germany: Ethics Commission |
Expert system Transtheoretical Model of Behavior Change Brief intervention General hospital |
Mental Disorders Alcoholism Substance-Related Disorders Drinking Behavior |
Disorders of Environmental Origin Alcohol-Related Disorders Alcohol Drinking Ethanol |
Mental Disorders Substance-Related Disorders Drinking Behavior |
Disorders of Environmental Origin Alcohol-Related Disorders Alcohol Drinking |