Alcohol Expert System Intervention for Problematic Alcohol Use

NCT ID: NCT00400010

Last Updated: 2014-04-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

347 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2006-11-30

Brief Summary

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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

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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.

Conditions

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Alcohol-related Disorders Alcohol Drinking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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

Group Type EXPERIMENTAL

Expert System Intervention

Intervention Type BEHAVIORAL

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.

Control group

Controls received a brochure on health behavior

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Alcohol Abuse
* Alcohol Dependence
* At-risk drinking

Exclusion Criteria

* Current treatment for alcohol problems
* Terminal illness
Minimum Eligible Age

18 Years

Maximum Eligible Age

64 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role collaborator

University of Luebeck

OTHER

Sponsor Role lead

Responsible Party

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Hans-Jürgen Rumpf

PD Dr. Hans-Jürgen Rumpf

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hans-Juergen Rumpf, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Luebeck

Locations

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University of Luebeck, Dpt. of Psychiatry and Psychotherapy

Lübeck, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 22516146 (View on PubMed)

Other Identifiers

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01EB0421-1

Identifier Type: -

Identifier Source: org_study_id

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