Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
DOH93-TD-1050
Study information
Scientific title
Effects of Brief Intervention for general hospital inpatients with unhealthy alcohol use in Taiwan: A randomised, controlled trial
Acronym
BI
Study hypothesis
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.
Ethics approval
Mackay Memorial Hospital Institutional Review Board. Date of approval: 07/02/2003 (ref: MMH-I-S-0174)
Study design
Randomised controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Alcohol abuse/ alcohol dependence.
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
Number of drinks per week at 4, 9 and 12 month.
Secondary outcome measures
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)
Overall trial start date
01/01/2004
Overall trial end date
31/12/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Adult
Gender
Male
Target number of participants
600 (300 per group)
Total final enrolment
616
Participant exclusion criteria
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
Recruitment start date
01/01/2004
Recruitment end date
31/12/2005
Locations
Countries of recruitment
Taiwan
Trial participating centre
Department of Psychiatry
Taipei County
25115
Taiwan
Sponsor information
Organisation
Department of Health (Taiwan)
Sponsor details
5F
No.100
Aiguo E Road
Jhongjheng District
Taipei City 100
Taipei County
25115
Taiwan
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Department of Health (Taiwan)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2011 results in: https://www.ncbi.nlm.nih.gov/pubmed/21205050 (added 04/06/2019)