ClinicalTrials.gov
ClinicalTrials.gov Menu

Alcohol Expert System Intervention for Problematic Alcohol Use

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00400010
Recruitment Status : Completed
First Posted : November 16, 2006
Last Update Posted : April 2, 2014
Sponsor:
Collaborator:
German Federal Ministry of Education and Research
Information provided by (Responsible Party):
Hans-Jürgen Rumpf, University of Luebeck

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
Alcohol-related Disorders Alcohol Drinking Behavioral: Expert System Intervention Not Applicable

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 Type : Interventional  (Clinical Trial)
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 : October 2004
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Average alcohol consumption (QF) gr/alc. per day [ Time Frame: 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 [ Time Frame: 12 months ]
    Readiness to change questionnaire



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Alcohol Abuse
  • Alcohol Dependence
  • At-risk drinking

Exclusion Criteria:

  • Current treatment for alcohol problems
  • Terminal illness

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: November 16, 2006    Key Record Dates
Last Update Posted: April 2, 2014
Last Verified: April 2014

Keywords provided by Hans-Jürgen Rumpf, 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
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs