Alcohol Expert System Intervention for Problematic Alcohol Use

Sponsor
University of Luebeck (Other)
Overall Status
Completed
CT.gov ID
NCT00400010
Collaborator
German Federal Ministry of Education and Research (Other)
347
1
2
25
13.9

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Expert System Intervention
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
347 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Randomized Controlled Trial of a Expert System for Patients With At-risk Drinking, Alcohol Abuse and Alcohol Dependence in General Hospital
Study Start Date :
Oct 1, 2004
Actual Primary Completion Date :
Nov 1, 2005
Actual Study Completion Date :
Nov 1, 2006

Arms and Interventions

Arm Intervention/Treatment
Experimental: Expert System Intervention

Computerized Expert System Intervention based on the Transtheoretical Model of Change: 1. Normative feedback and feedback on motivational variables during the first week of hospital stay 2. Ipsative feedback on drinking behavior and motivation to change after three months

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.

No Intervention: Control group

Controls received a brochure on health behavior

Outcome Measures

Primary Outcome Measures

  1. Average alcohol consumption (QF) gr/alc. per day [12 months]

    Main outcome is reduction in daily average alcohol consumption, operationalized by a Quantity-/Frequency measure

Secondary Outcome Measures

  1. Readiness to change drinking behavior [12 months]

    Readiness to change questionnaire

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Alcohol Abuse

  • Alcohol Dependence

  • At-risk drinking

Exclusion Criteria:
  • Current treatment for alcohol problems

  • Terminal illness

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Luebeck, Dpt. of Psychiatry and Psychotherapy Luebeck Germany 23538

Sponsors and Collaborators

  • University of Luebeck
  • German Federal Ministry of Education and Research

Investigators

  • Principal Investigator: Hans-Juergen Rumpf, Ph.D., University of Luebeck

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hans-Jürgen Rumpf, PD Dr. Hans-Jürgen Rumpf, University of Luebeck
ClinicalTrials.gov Identifier:
NCT00400010
Other Study ID Numbers:
  • 01EB0421-1
First Posted:
Nov 16, 2006
Last Update Posted:
Apr 2, 2014
Last Verified:
Apr 1, 2014
Keywords provided by Hans-Jürgen Rumpf, PD Dr. Hans-Jürgen Rumpf, University of Luebeck
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 2, 2014