Alcohol Expert System Intervention for Problematic Alcohol Use

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00400010
• Other study ID #: 01EB0421-1
• Status: Completed
• Phase: N/A
• First received: November 14, 2006
• Last updated: April 1, 2014
• Start date: October 2004
• Est. completion date: November 2006

Study information

• Verified date: April 2014
• Source: University of Luebeck
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• 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

Study Design

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

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol-Related Disorders

Intervention

Behavioral:
• Expert System Intervention
Questionnaires on motivation to change and alcohol consumption were assessed in a clinical interview. Data were entered in a Computer and a fully automatized feedback letter was generated by an expert system. The printed feedback letter was handed out to patients by study staff the following day.

Locations

Country	Name	City	State
Germany	University of Luebeck, Dpt. of Psychiatry and Psychotherapy	Luebeck

Sponsors (2)

Lead Sponsor	Collaborator
University of Luebeck	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

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