Problem DrinkingBINCT00675519
An Evaluation of the Brief Interventional for Problem Drinkers Among Medical Inpatients
A study testing Motivational enhancement therapy in people with Problem Drinking, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Problem Drinking
- What is being tested?
- Motivational enhancement therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTaiwan
- Study dates
- Jan 2004to Dec 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Psychotic disorders or symptoms, bipolar disorder, major suicide risk,
- serious medical illness, or currently being treated in psychiatric clinics/or alcohol treatment program.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Problem Drinking
- Being tested
- Motivational enhancement therapy
- Keywords
- problem drinkers
- Medical subject headings
- Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational enhancement therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| BI | Experimental | Not described Receives: Behavioral: Motivational enhancement therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome was the number of drinks per week
Measured: 4-, 9- and 12-month
Secondary outcomes (1)
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.
Measured: 4-, 9 and 12-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2008 (estimated)
- Study startJan 2004
- Primary completionDec 2005
- Study completionDec 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Problem DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Principal investigator, Shen-Ing,Liu, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00675519
- Sponsor's protocol ID
- DOH93-TD-1050
- Acronym
- BI
- Status last verified
- Apr 2015
- First submitted
- 28 Apr 2008
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Brief Intervention for General Hospital Inpatients With Unhealthy Alcohol Use in Taiwan: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT00675519
- Acronym / sponsor ID
- BI / DOH93-TD-1050
- Conditions
- Problem Drinking
- Keywords
- problem drinkers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Jan 2004
- Primary completion
- Dec 2005 (actual)
- Study completion
- Dec 2005 (actual)
- First posted
- 9 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BI | Experimental | Behavioral: Motivational enhancement therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Psychotic disorders or symptoms, bipolar disorder, major suicide risk,
- serious medical illness, or currently being treated in psychiatric clinics/or alcohol treatment program.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational enhancement therapyMotivational 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. | Behavioural | BI |
Primary outcome
The primary outcome was the number of drinks per week
Time frame: 4-, 9- and 12-month
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational enhancement therapy in people with Problem Drinking, run by Mackay Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome was the number of drinks per week (time frame: 4-, 9- and 12-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2015.