Brief Intervention for Heavy Drinkers

Alcohol Abuse Clinical Trial

Official title:

Brief Intervention for Heavy Drinkers - a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00728767
• Other study ID #: NIPH - 1948
• Status: Completed
• Phase: Phase 3
• First received: August 1, 2008
• Last updated: April 13, 2011
• Start date: January 2008
• Est. completion date: December 2009

Study information

• Verified date: August 2009
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine whether a brief intervention (a short conversation build on the principles of motivational interviewing) is effective in lowering self reported alcohol use in heavy drinkers.

Description:

Background and purpose:

The Danish national board of Health has awarded 5.6 million DKR to two studies that will test methods that can be used for effective and early detection of heavy drinkers. The study will be carried out in 9 Danish municipalities in 2008. The study is part of the 'Diet, Smoking, Alcohol and Exercise' nationwide health study of the Danish population. It takes place in 13 municipalities in 2007 and 2008.

The study will determine whether a brief intervention is effective in lowering self reported alcohol use in heavy drinkers.

Design:

The experiment is designed as a randomized controlled trial, where heavy drinkers will be allocated to either:

A) a intervention group receiving a short (about 10 minutes) motivational conversation (build on the principles of motivational interviewing) and two leaflets about alcohol ('Good advice about drinking less' and 'Learn more about alcohol') and a sheet about local alcohol treatment possibilities. The Intervention group is also offered a brief telephone follow up call 4 weeks later. The purpose of this is to maintain the participant's motivation to reduce drinking.

B) a control group receiving two leaflets about alcohol ('Good advice about drinking less' and 'Learn more about alcohol') and a sheet about local alcohol treatment possibilities.

The study will take place in premises linked to the 'Diet, Smoking, Alcohol and Exercise' nationwide health study.

After 6 and 12 months there will be follow-up and the participants will receive a questionnaire with questions about their alcohol consumption.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 772
• Est. completion date: December 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Participants must be invited to the Danish 'Diet, Smoking, Alcohol and Exercise' nationwide health study.

• Participants must have responded to an Internet questionnaire.

• Participants must have a weekly alcohol consumption above the recommended Danish limits (168 grams of alcohol for women, 252 grams of alcohol for men).

Exclusion Criteria:

• Weekly alcohol consumption less than 168 grams of alcohol for women and 252 grams of alcohol for men.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholic Intoxication

Intervention

Other:
• Brief intervention
The intervention consists of a brief conversation based on the principles of motivational interviewing, including Rollnicks scales to assess the motivation and importance for change. The intervention has duration of about 10 minutes and qualifies as a hybrid between a minimal intervention and a brief intervention. The intervention also consists of two leaflets ('Good advice about drinking less' and 'Learn more about alcohol') on the harmful in having an alcohol above recommended limits, and a sheet about local alcohol treatment possibilities. The Intervention group is also offered a brief telephone follow up call 4 weeks later. The purpose of this is to maintain the participant's motivation to reduce drinking. Employees had been instructed to ask these questions during the intervention: "What are you already doing to restrain your drinking?" And "What can you do more?"
• Control group
The intervention consists of two leaflets ('Good advice about drinking less' and 'Learn more about alcohol') on the harmful in having an alcohol use above the recommended limits, and a sheet about local alcohol treatment possibilities.

Locations

Country	Name	City	State
Denmark	The municipiality of Aeroe	Aeroeskoebing
Denmark	The municipiality of Albertslund	Albertslund
Denmark	The municipiality of Broendby	Brøndby
Denmark	The municipiality of Frederiksberg	Frederiksberg
Denmark	The municipality of Naestved	Naestved	Næstved
Denmark	The municipality of Guldborgsund	Nykøbing F.
Denmark	The municipiality of Faaborg-Midtfyn	Ringe
Denmark	The municipiality of Silkeborg	Silkeborg
Denmark	The municipiality of Varde	Varde

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern Denmark	National Board of Health, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of 25% in self reported alcohol consumption with an average volume of approximately 38-41 grams alcohol per week in the intervention group. In the control group we expect that 10% will reduce their consumption equivalent.		6 and 12 months	No