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Completed

NCT Number: NCT00751985

Web-based Ultra-brief Intervention for Heavy Drinkers Trial

The purpose of the study is to determine whether a web-based ultra-brief intervention, consisting of personalized normative feedback or standardized self-help material, 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

University of Southern Denmark, National Institute of Public Health

Copenhagen, 1399, Denmark

About this study

Background and purpose:

The Danish national board of Health has awarded funds for 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 12 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 purpose of the study is to determine whether a web-based ultra-brief intervention, consisting of personalized normative feedback or standardized self-help material, 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) an intervention group receiving web-based personalized normative feedback (PFI) B) an intervention group receiving web-based self-help material (SHM) C) a control group receiving nothing.

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

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 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.
  • Participants who have not informed their email address.

Treatment and study plan

Personalised normative feedback (PNF)

Other

The intervention can be classified as a minimal ultra-brief intervention consisting of only a single session.

The brief personalised normative feedback will comprise the result of the participant's amount of alcohol consumption, previously given in an online questionnaire.

Alongside, information about alcohol and how it might affect them at their current drinking levels is provided. The feedback is also comparing their drinking, in graphical format, to the average drinking in the municipality concerned. Contact details are also provided about local alcohol treatment possibilities if the participants feel they need further help.

Self-help material

Other

The intervention can be classified as a minimal ultra-brief intervention consisting of only a single session.

The intervention comprises of on-line self-help material informing about the participant's response from an online questionnaire shows that the participant's alcohol consumption exceeds the recommended limits.

Alongside, information about alcohol and how it might affect them at their current drinking levels is provided. Contact details are also provided about local alcohol treatment possibilities if the participants feel they need further help.

Control

Other

The participant is being informed about their allocation to the control group.

Primary outcomes

  1. Reduction of 15% in alcohol consumption with an average volume of approximately 38-41 grams alcohol per week in the PFI group . In the self-help material group we expect that 5 - 10% will reduce their consumption equivalent.

    Time frame: 12 months

    Outcome measure was based on self-reported drinking during a typical week.

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Collaborators

  • National Board of Health, Denmark

Registry information

Official study title

Web-based Ultra-brief Intervention for Heavy Drinkers - a Randomized Controlled Trial Comparing Personalized Normative Feedback With Self-help Material

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 12, 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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