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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
University of Luebeck
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 23, 2006
    Last Updated
    October 23, 2006
    Sponsor
    University of Luebeck
    Collaborators
    German Federal Ministry of Education and Research
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    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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