- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00675519
An Evaluation of the Brief Interventional for Problem Drinkers Among Medical Inpatients (BI)
April 6, 2015 updated by: Shen-Ing,Liu, Mackay Memorial Hospital
Effects of Brief Intervention for General Hospital Inpatients With Unhealthy Alcohol Use in Taiwan: A Randomized, Controlled Trial
Compared with control participants at post-intervention follow-ups, unhealthy drinkers who receive the screening and brief intervention will (1) report reduced alcohol consumption among all patients, and (2) report reduced alcohol-related problems and health care utilization.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Alcohol use is associated with a number of adverse health and economic effects.
Problem drinking is associated with increased mortality rates and with premature mortality.
As a result of these findings, the testing of the effectiveness of alcohol abuse prevention strategies has become an important national research priority.
Secondary prevention of alcohol problems covers the methods used for early detection and treatment of people with excessive alcohol consumption.
These preventive methods are referred to as brief interventions.
Brief intervention is a short-term counseling strategy based on motivational enhancement therapy that concentrates on changing patient behavior and increasing patient compliance with therapy.
It has been shown to be effective for helping socially stable problem drinkers to reduce or stop drinking, for motivating alcohol-dependent patients to enter long-term alcohol treatment, and for treating some alcohol-dependent patients for whom the goal is abstinence.
The aims of this study are to examine the outcomes of a brief intervention to reduce alcohol consumption by problem drinkers among medical inpatients in general hospital setting.
The study design is a randomized controlled clinical trial.
Patients will be recruited from adult patients who are admitted to medical or surgical wards of a general hospital.
All adult inpatients of a general hospital, aged 18 to 65 years, will be consecutively screened with the Alcohol Use Disorders Identification Test for identifying the problem drinkers.
All patients who screen positive and who have signed a consent form will be contacted by a researcher and invited to participate in a face-to-face interview to determine their eligibility for the trial.
The inclusion criteria are problems drinkers, defined as men who drank more than 21 units a week and women who drank more than 14 units a week.
Patients will be excluded from participation in the study if they are younger than 18 years or older than 65 years, and have attended an alcohol treatment program in the last 3 months.
Screened positives will then be interviewed using the instrument of SCAN to confirm the diagnosis of alcohol use disorders.
The patients who fulfill the criteria will be randomized into one of the three following groups: (1) control group will be provided with routine inpatient usual care; (2) experimental group 1: physicians and nurses in charge will be informed of the results of alcohol consumption screening, in addition to providing routine inpatient usual care; (3) experimental group 2 will receive brief intervention, in addition to treatment protocols provided for experimental group 1. Brief intervention, offered twice by well-trained therapists, is 15-minute short-term individual consultation, giving alcohol health education, increasing their motivation to alcohol abstinence, teaching alcohol abstinence principle, and in order to ameliorate the over-drinking problems in these cases.
The main outcome measures are alcohol use measures, which will be evaluated at 12-week after the study recruitment.
Study Type
Interventional
Enrollment (Actual)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Taipei, Taiwan, 251
- Mackay Memorial Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- men aged 18-65 admitted to medical or surgical wards in a medical center in Taipei;
- Unhealthy alcohol users defined as men who currently (past 3 months) drank risky amounts, > 168 g alcohol per week or usually drank more than 32 g/ occasion.
- Patients provide written informed consent
Exclusion Criteria:
- Psychotic disorders or symptoms, bipolar disorder, major suicide risk,
- serious medical illness, or currently being treated in psychiatric clinics/or alcohol treatment program.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: BI
|
Motivational enhancement therapy begins with the assumption that the responsibility and capacity for change lie within the client.
The therapist begins by providing individualized feedback about the effects of the patient's drinking.
Working closely together, therapist and patient explore the benefits of abstinence, review treatment options, and design a plan to implement treatment goals.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The primary outcome was the number of drinks per week
Time Frame: 4-, 9- and 12-month
|
4-, 9- and 12-month
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
included days abstinent, the number of heavy drinking episodes (> 5 drinks/ occasion); the proportions of patients with risky drinking (> 14 drinks per week) , heavier drinking (> 20 drinks per week), alcohol-related problems and health care utilization.
Time Frame: 4-, 9 and 12-month
|
4-, 9 and 12-month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2004
Primary Completion (ACTUAL)
December 1, 2005
Study Completion (ACTUAL)
December 1, 2005
Study Registration Dates
First Submitted
April 28, 2008
First Submitted That Met QC Criteria
May 8, 2008
First Posted (ESTIMATE)
May 9, 2008
Study Record Updates
Last Update Posted (ESTIMATE)
April 8, 2015
Last Update Submitted That Met QC Criteria
April 6, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- DOH93-TD-1050
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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