Brief Intervention for Heavy Drinkers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Brief Intervention for Heavy Drinkers - a Randomized Controlled Trial

Conditions
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Alcohol Abuse

Intervention / Treatment
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* Other: Brief intervention
* Other: Control group


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Other: Brief intervention<br>* 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?<br>|
| Placebo Comparator: 2<br> | Other: Control group<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Heavy drinking, Brief intervention, Alcohol prevention, Randomized trial, Motivational interviewing, Intervention Studies, prevention & control