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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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