Stepped Interventions for Problem Drinkers
Primary Purpose
Alcohol-Related Disorders, Alcohol Drinking
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Brief intervention
Sponsored by
About this trial
This is an interventional treatment trial for Alcohol-Related Disorders focused on measuring Brief intervention, Motivational Interviewing, Primary care, Stepped-care
Eligibility Criteria
Inclusion Criteria:
- Alcohol dependence
- Alcohol abuse
- At-risk drinking
- Binge drinking
Exclusion Criteria:
- Current treatment for alcohol problems
Sites / Locations
Outcomes
Primary Outcome Measures
Reduced alcohol consumption
Secondary Outcome Measures
Readiness to change drinking behavior
Full Information
NCT ID
NCT00391742
First Posted
October 23, 2006
Last Updated
October 23, 2006
Sponsor
University of Luebeck
Collaborators
German Federal Ministry of Education and Research
1. Study Identification
Unique Protocol Identification Number
NCT00391742
Brief Title
Stepped Interventions for Problem Drinkers
Official Title
A Stepped-Care Approach for General Practice Patients With Alcohol Use Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
October 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Luebeck
Collaborators
German Federal Ministry of Education and Research
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alcohol-Related Disorders, Alcohol Drinking
Keywords
Brief intervention, Motivational Interviewing, Primary care, Stepped-care
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Single
Allocation
Randomized
Enrollment
450 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Brief intervention
Primary Outcome Measure Information:
Title
Reduced alcohol consumption
Secondary Outcome Measure Information:
Title
Readiness to change drinking behavior
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Alcohol dependence
Alcohol abuse
At-risk drinking
Binge drinking
Exclusion Criteria:
Current treatment for alcohol problems
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans-Jürgen Rumpf, Ph D
Organizational Affiliation
University of Lübeck
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
22516146
Citation
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.
Results Reference
derived
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Stepped Interventions for Problem Drinkers
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