NCT00391742

Brief Summary

In a randomized controlled trial, patients recruited in general practices and fulfilling criteria for alcohol dependence, alcohol abuse, at-risk drinking or binge drinking will be allocated to three conditions: (1) Stepped Care intervention (SC): up to 4 interventions depending on the success of the previous intervention (assessed by alcohol consumption and self-efficacy) which start with a minimal intervention (written feedback and manuals) and are followed by more intensive interventions (counseling) in case of no success, (2) Fixed Care intervention (FC): A fixed number of counseling sessions plus written feedback and manuals, and (3) a control group (CG) booklet on health behavior. Outcome assessment will be conducted in all three groups after 12 months. The hypothesis is that SC and FC do not differ in effectiveness but SC is more economic.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2001

Typical duration for not_applicable

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, 2001

Completed
2.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2004

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 23, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 24, 2006

Completed
Last Updated

October 24, 2006

Status Verified

October 1, 2006

First QC Date

October 23, 2006

Last Update Submit

October 23, 2006

Conditions

Alcohol-Related DisordersAlcohol Drinking

Keywords

Brief interventionMotivational InterviewingPrimary careStepped-care

Outcome Measures

Primary Outcomes (1)

  • Reduced alcohol consumption

Secondary Outcomes (1)

  • Readiness to change drinking behavior

Interventions

Brief interventionBEHAVIORAL

Eligibility Criteria

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

You may qualify if:

  • Alcohol dependence
  • Alcohol abuse
  • At-risk drinking
  • Binge drinking

You may not qualify if:

  • Current treatment for alcohol problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Substance-Related DisordersChemically-Induced DisordersMental DisordersDrinking BehaviorBehavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Hans-Jürgen Rumpf, Ph D

    University of Lübeck

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 23, 2006

First Posted

October 24, 2006

Study Start

October 1, 2001

Study Completion

June 1, 2004

Last Updated

October 24, 2006

Record last verified: 2006-10