NCT00400010

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
347

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2004

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2006

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 16, 2006

Completed
Last Updated

April 2, 2014

Status Verified

April 1, 2014

Enrollment Period

1.1 years

First QC Date

November 14, 2006

Last Update Submit

April 1, 2014

Conditions

Alcohol-related DisordersAlcohol Drinking

Keywords

Expert systemTranstheoretical Model of Behavior ChangeBrief interventionGeneral hospital

Outcome Measures

Primary Outcomes (1)

  • Average alcohol consumption (QF) gr/alc. per day

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

    12 months

Secondary Outcomes (1)

  • Readiness to change drinking behavior

    12 months

Study Arms (2)

Expert System Intervention

EXPERIMENTAL

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

Control group

NO INTERVENTION

Controls received a brochure on health behavior

Interventions

Expert System InterventionBEHAVIORAL

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.

Expert System Intervention

Eligibility Criteria

Age18 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Alcohol Abuse
  • Alcohol Dependence
  • At-risk drinking

You may not qualify if:

  • Current treatment for alcohol problems
  • Terminal illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Luebeck, Dpt. of Psychiatry and Psychotherapy

Lübeck, 23538, Germany

Location

Related Publications (1)

  • 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.

    PMID: 22516146DERIVED

MeSH Terms

Conditions

Alcohol-Related DisordersAlcohol Drinking

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersDrinking BehaviorBehavior

Study Officials

  • Hans-Juergen Rumpf, Ph.D.

    University of Luebeck

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PD Dr. Hans-Jürgen Rumpf

Study Record Dates

First Submitted

November 14, 2006

First Posted

November 16, 2006

Study Start

October 1, 2004

Primary Completion

November 1, 2005

Study Completion

November 1, 2006

Last Updated

April 2, 2014

Record last verified: 2014-04

Locations

DE(1)