Alcohol Expert System Intervention for Problematic Alcohol Use

This study has been completed.
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Hans-Jürgen Rumpf, University of Luebeck
ClinicalTrials.gov Identifier:
NCT00400010
First received: November 14, 2006
Last updated: April 1, 2014
Last verified: April 2014
  Purpose

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
Alcohol-related Disorders
Alcohol Drinking
Behavioral: Expert System Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by University of Luebeck:

Primary Outcome Measures:
  • Average alcohol consumption (QF) gr/alc. per day [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Main outcome is reduction in daily average alcohol consumption, operationalized by a Quantity-/Frequency measure


Secondary Outcome Measures:
  • Readiness to change drinking behavior [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Readiness to change questionnaire


Enrollment: 347
Study Start Date: October 2004
Study Completion Date: November 2006
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Alcohol Abuse
  • Alcohol Dependence
  • At-risk drinking

Exclusion Criteria:

  • Current treatment for alcohol problems
  • Terminal illness
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00400010

Locations
Germany
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
  More Information

No publications provided by University of Luebeck

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Hans-Jürgen Rumpf, PD Dr. Hans-Jürgen Rumpf, University of Luebeck
ClinicalTrials.gov Identifier: NCT00400010     History of Changes
Other Study ID Numbers: 01EB0421-1
Study First Received: November 14, 2006
Last Updated: April 1, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by University of Luebeck:
Expert system
Transtheoretical Model of Behavior Change
Brief intervention
General hospital

Additional relevant MeSH terms:
Alcohol Drinking
Alcohol-Related Disorders
Drinking Behavior
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014