Alcohol Expert System Intervention for Problematic Alcohol Use
Primary Purpose
Alcohol-related Disorders, Alcohol Drinking
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Expert System Intervention
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol-related Disorders focused on measuring Expert system, Transtheoretical Model of Behavior Change, Brief intervention, General hospital
Eligibility Criteria
Inclusion Criteria:
- Alcohol Abuse
- Alcohol Dependence
- At-risk drinking
Exclusion Criteria:
- Current treatment for alcohol problems
- Terminal illness
Sites / Locations
- University of Luebeck, Dpt. of Psychiatry and Psychotherapy
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Expert System Intervention
Control group
Arm Description
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
Controls received a brochure on health behavior
Outcomes
Primary Outcome Measures
Average alcohol consumption (QF) gr/alc. per day
Main outcome is reduction in daily average alcohol consumption, operationalized by a Quantity-/Frequency measure
Secondary Outcome Measures
Readiness to change drinking behavior
Readiness to change questionnaire
Full Information
NCT ID
NCT00400010
First Posted
November 14, 2006
Last Updated
April 1, 2014
Sponsor
University of Luebeck
Collaborators
German Federal Ministry of Education and Research
1. Study Identification
Unique Protocol Identification Number
NCT00400010
Brief Title
Alcohol Expert System Intervention for Problematic Alcohol Use
Official Title
Randomized Controlled Trial of a Expert System for Patients With At-risk Drinking, Alcohol Abuse and Alcohol Dependence in General Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
November 2005 (Actual)
Study Completion Date
November 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Luebeck
Collaborators
German Federal Ministry of Education and Research
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol-related Disorders, Alcohol Drinking
Keywords
Expert system, Transtheoretical Model of Behavior Change, Brief intervention, General hospital
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
347 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Expert System Intervention
Arm Type
Experimental
Arm Description
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
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Controls received a brochure on health behavior
Intervention Type
Behavioral
Intervention Name(s)
Expert System Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Average alcohol consumption (QF) gr/alc. per day
Description
Main outcome is reduction in daily average alcohol consumption, operationalized by a Quantity-/Frequency measure
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Readiness to change drinking behavior
Description
Readiness to change questionnaire
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Alcohol Abuse
Alcohol Dependence
At-risk drinking
Exclusion Criteria:
Current treatment for alcohol problems
Terminal illness
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans-Juergen Rumpf, Ph.D.
Organizational Affiliation
University of Luebeck
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Luebeck, Dpt. of Psychiatry and Psychotherapy
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
12. IPD Sharing Statement
Citations:
PubMed Identifier
22516146
Citation
Bischof G, Freyer-Adam J, Meyer C, John U, Rumpf HJ. Changes in drinking behavior among control group participants in early intervention studies targeting unhealthy alcohol use recruited in general hospitals and general practices. Drug Alcohol Depend. 2012 Sep 1;125(1-2):81-8. doi: 10.1016/j.drugalcdep.2012.03.018. Epub 2012 Apr 18.
Results Reference
derived
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Alcohol Expert System Intervention for Problematic Alcohol Use
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