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ISRCTN
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ISRCTN70428574
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ClinicalTrials.gov identifier
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Public title
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An evaluation of the brief intervention for problem drinkers among inpatients
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Scientific title
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Effects of Brief Intervention for general hospital inpatients with unhealthy alcohol use in Taiwan: A randomised, controlled trial
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Acronym
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BI
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Serial number at source
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DOH93-TD-1050
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Study hypothesis
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Compared with control participants at post-intervention follow-ups, unhealthy drinkers who receive the screening and brief intervention will report 1) reduced alcohol consumption and 2) reduced alcohol-related problems and health care utilization.
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Ethics approval
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Mackay Memorial Hospital Institutional Review Board. Date of approval: 07/02/2003 (ref: MMH-I-S-0174)
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Study design
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Randomised controlled trial.
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Countries of recruitment
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Taiwan
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Disease/condition/study domain
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Alcohol abuse/ alcohol dependence.
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Participants - inclusion criteria
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1. Men aged 18-65 admitted to medical or surgical wards in a medical centre in Taipei
2. Unhealthy alcohol users defined as men who currently (past 3 months) drink risky amounts, >168 g alcohol per week, or usually drank more than 32 g per occasion
3. Patients who provide written informed consent
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Participants - exclusion criteria
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1. Psychotic disorders or symptoms
2. Bipolar disorder
3. Major suicide risk
4. Serious medical illness
5. Currently being treated in psychiatric clinics/ or alcohol treatment program
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Anticipated start date
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01/01/2004
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Anticipated end date
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31/12/2005
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Status of trial
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Completed
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Patient information material
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Target number of participants
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600 (300 per group)
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Interventions
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Patients receive at least one session of the 30-minute brief intervention treatment, according to the severity of drinking problems. For heavier drinkers and patients with alcohol use disorders (abuse/dependence), one booster session was provided either during admission or after discharge. For dependent drinkers who required provision of specified advice and referral to specialty care for alcohol assessment and treatment, interventionist could provide the third booster session. The brief intervention drew on the FRAMES model, whereby each of the six elements of feedback, responsibility, advice, motivation, empathy and self-efficacy were incorporated into the intervention. Advice was supplemented with a self-help booklet at the first session of brief intervention.
Control group: Patients in the control group received treatment as usual (that is, no intervention was given; no comment was made about the content of the baseline assessment). Psychiatrists were available by referral during admission. The physician in charge, however, may have advised the patient to modify his alcohol consumption or referred patient to psychiatrist, according to his normal practice.
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Primary outcome measure(s)
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Number of drinks per week at 4, 9 and 12 month.
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Secondary outcome measure(s)
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1. Outcomes related to alcohol consumption (past 30 days):
1.1. Days abstinent
1.2. Number of heavy drinking episodes (>= 5 drinks/ occasion)
1.3. Proportions of patients with risky drinking (>14 drinks per week) and heavier drinking (>20 drinks per week)
2. Alcohol-related outcomes:
2.1. Alcohol-related problems (problems at work/ school; problems with family and friends; legal consequences; and alcohol-related injuries)
2.2. Health care utilisation (number of days in hospitalisation and emergency department visits)
3. Other outcome measures:
3.1. Self-reported receipt of alcohol assistance by patients with alcohol dependence during 12 months. Assistance included outpatient specialty treatment, residential treatment, or mutual-help groups (for example, Alcoholics Anonymous)
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Sources of funding
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Department of Health (Taiwan)
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Trial website
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Publications
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Contact name
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Dr
Shen-Ing
Liu
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Address
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Department of Psychiatry
Mackay Memorial Hospital
No 45
Ming-Shan Road
Tam-Shui
Chu-Wei
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City/town
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Taipei County
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Zip/Postcode
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25115
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Country
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Taiwan
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Sponsor
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Department of Health (Taiwan)
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Address
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5F, No.100
Aiguo E Road
Jhongjheng District
Taipei City 100
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City/town
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Taipei County
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Zip/Postcode
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25115
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Country
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Taiwan
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Sponsor website:
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http://english.taipei.gov.tw/health
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Date applied
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05/04/2008
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Last edited
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01/05/2008
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Date ISRCTN assigned
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01/05/2008
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