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Completed

NCT Number: NCT00728767

Brief Intervention for Heavy Drinkers

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.

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Key information

Conditions

Alcohol Abuse Alcohol-Related Disorders Alcoholism Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

The municipality of Naestved, Næstved, Denmark

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Brief intervention

Other

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

Other

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.

Primary outcomes

  1. 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.

    Time frame: 6 and 12 months

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • National Board of Health, Denmark

Registry information

Official study title

Brief Intervention for Heavy Drinkers - a Randomized Controlled Trial

Important dates

Study start
2008
Primary completion
2008
Study completion
2009
First posted
Aug 6, 2008
Registry last updated
Apr 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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