We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00423904
Previous Study | Return to List | Next Study

Brief Alcohol Intervention in General Hospitals

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00423904
Recruitment Status : Completed
First Posted : January 18, 2007
Last Update Posted : January 18, 2007
German Federal Ministry of Education and Research
Information provided by:
University Medicine Greifswald

Brief Summary:
The purpose of the study is to reveal the most promising procedure for implementing alcohol screening and intervention in general hospitals and to find out, if and to which extent non-specialist health professionals can be qualified to carry out motivational intervention on their own or if there is a need for a specialized counseling services. In a randomized controlled trial, patients recruited in general hospitals and fulfilling criteria for alcohol dependence, alcohol abuse, at-risk drinking or heavy episodic drinking will be allocated to three conditions: (1) Intervention by a liaison service (LC): Counselling based on the Transtheoretical Model of behaviour change (TTM) which will be provided by staff of the study (psychologists/ social worker) trained in Motivational Interviewing (MI), (2) Intervention by hospital physicians (PC): Counselling will be provided by hospital physicians trained in MI, and (3) Control group (CC): Treatment as usual, assessment only. Outcome assessment will be conducted after 12 months and includes abstinent point prevalence rates, drinks per day, help-seeking, stage progress and cost-effectiveness analysis.

Condition or disease Intervention/treatment Phase
Alcohol Dependence Alcohol Abuse At-Risk-Drinking Heavy Episodic Drinking Behavioral: Brief intervention Phase 2

Detailed Description:
Background: High prevalence rates (10 - 25 %) and a promising setting for proactive intervention strategies make the general hospital a first choice setting for secondary prevention of alcohol-related disorders. Efficient screening instruments have been developed for early detection. With regard to the severity of alcohol problem (e.g. alcohol dependence vs. heavy episodic drinking) and the motivation to change, the target group is very heterogeneous. Although there are counseling strategies that take into account this heterogeneity, there is still a lack of implementation and poor knowledge about different implementation strategies in routine care. Objectives: To evaluate the effectiveness of a proactive secondary preventive intervention based on the TTM and on MI in a representative sample of general hospital patients carried out by a liaison service versus non-specialist physicians trained in counseling techniques by staff of the study. Methods: A sample of 1,479 alcohol at-risk-drinking, alcohol abusing or alcohol dependent patients from four general hospitals detected by screening questionnaires will be assigned to (1) a group counseled by an addiction liaison service, (2) a group counseled by the physicians of the ward, and (3) to an assessment-only condition with treatment as usual. Outcome will be measured one year later and will include abstinence point prevalence rates, stage progress, help seeking, and cost-effectiveness analysis. Expected impact: The project will yield new scientific knowledge on how to implement early intervention for alcohol at-risk-drinking and alcohol use disorders in the general hospital. Results of the study shall be transferred to nationwide practice guideline proposals. The study will contribute to the improvement of the health care system as well as the education of medical students. The study is designed to reveal empirical evidence for proactive TTM-based interventions for individuals suffering from a prevalent substance use disorder.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 1035 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single
Primary Purpose: Educational/Counseling/Training
Official Title: Implementing Early Intervention for Alcohol Use Disorders in the General Hospital
Study Start Date : October 2001
Study Completion Date : August 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Reduced alcohol consumption
  2. Increased alcohol-specific help-seeking

Secondary Outcome Measures :
  1. Increased readiness to change drinking behaviour
  2. Increased well-being

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Alcohol dependence
  • Alcohol abuse
  • At-risk drinking
  • Heavy episodic drinking

Exclusion Criteria:

  • Persons physically and mentally not capable of participating in study
  • Persons with a hospital stay of less than 24 hours

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00423904

Sponsors and Collaborators
University Medicine Greifswald
German Federal Ministry of Education and Research
Layout table for investigator information
Principal Investigator: Jennis Freyer-Adam, Dr University Medicine Greifswald
Principal Investigator: Ulfert Hapke, Dr University of Applied Sciences Muenster
Study Director: Ulrich John, Prof Dr University Medicine Greifswald
Layout table for additonal information
ClinicalTrials.gov Identifier: NCT00423904    
Other Study ID Numbers: E1_P1
First Posted: January 18, 2007    Key Record Dates
Last Update Posted: January 18, 2007
Last Verified: January 2007
Keywords provided by University Medicine Greifswald:
Early intervention
Brief intervention
general hospital
Additional relevant MeSH terms:
Layout table for MeSH terms
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders