Stepped Interventions for Problem Drinkers

Alcohol Drinking Clinical Trial

Official title:

A Stepped-Care Approach for General Practice Patients With Alcohol Use Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00391742
• Other study ID #: SIP
• Status: Completed
• Phase: N/A
• First received: October 23, 2006
• Last updated: October 23, 2006
• Start date: October 2001
• Est. completion date: June 2004

Study information

• Verified date: October 2006
• Source: University of Luebeck
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: June 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Alcohol dependence

• Alcohol abuse

• At-risk drinking

• Binge drinking

Exclusion Criteria:

• Current treatment for alcohol problems

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol-Related Disorders

Intervention

Behavioral:
• Brief intervention

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Luebeck	German Federal Ministry of Education and Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduced alcohol consumption
Secondary	Readiness to change drinking behavior