Stepped Interventions for Problem Drinkers

NCT ID: NCT00391742

Last Updated: 2006-10-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 450 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-10-31
• Study Completion Date: 2004-06-30

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.

Detailed Description

Background: A promising approach in secondary prevention of problem drinking is providing brief interventions in medical settings. In Germany, 80.0 % of alcohol dependent individuals have at least one contact per year to a general practitioner, and prevalence rates in general practices are high. Randomized controlled trials have shown that general practitioner interventions significantly reduce alcohol consumption. However, a current meta-analysis revealed that very brief interventions (5 - 20 minutes) showed no significant effect and extended brief interventions (several visits) showed homogeneous effectiveness only among women. On the other hand, resources are scarce and insufficient time is one main reason for general practitioners not to intervene. A stepped-care approach (starting with a very brief intervention and intensifying efforts in case of no success) could save resources and enlarge effectiveness; however research is lacking. Objectives: Comparing conventional brief interventions for patients with at-risk drinking, alcohol abuse or alcohol dependence in general practice with a stepped-care approach in a randomized controlled trial. Methods: About 7,500 screenings among consecutive general practice patients aged 18 to 64 will be conducted. Subjects fulfilling inclusion criteria (severe alcohol dependence excluded) will be randomly assigned to one of three conditions with 150 patients each: (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. Counseling will be based on Motivational Interviewing and provided by research staff. Outcome variables are alcohol consumption, amount of time and costs required for successful intervention. Expected impact: Findings are expected to provide evidence for a stepped-care approach to be used in primary care. This would be the first international result confirming such an approach in the alcohol field. If a stepped-care approach would work this could significantly save resources and enhance secondary prevention. Therefore, data is 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

Alcohol-Related Disorders; Alcohol Drinking

Keywords

Brief intervention; Motivational Interviewing; Primary care; Stepped-care

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

Brief intervention

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• Current treatment for alcohol problems

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Federal Ministry of Education and Research

OTHER_GOV

Sponsor Role: collaborator

University of Luebeck

OTHER

Sponsor Role: lead

Principal Investigators

Hans-Jürgen Rumpf, Ph D

Role: PRINCIPAL_INVESTIGATOR

University of Lübeck

References

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

SIP

Identifier Type: -

Identifier Source: org_study_id