Condition category
Mental and Behavioural Disorders
Date applied
05/04/2008
Date assigned
01/05/2008
Last edited
01/05/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Shen-Ing Liu

ORCID ID

Contact details

Department of Psychiatry
Mackay Memorial Hospital
No 45
Ming-Shan Road
Tam-Shui
Chu-Wei
Taipei County
25115
Taiwan

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 measures

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

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)

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

http://english.taipei.gov.tw/health

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes