Web-based Ultra-brief Intervention for Heavy Drinkers Trial

Alcohol Abuse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00751985
• Other study ID #: NIPH - 1948b
• Status: Completed
• Phase: Phase 3
• First received: September 11, 2008
• Last updated: April 13, 2011
• Start date: September 2008
• Est. completion date: February 2010

Study information

• Verified date: May 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 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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1380
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• 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 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.

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:
• Personalised normative feedback (PNF)
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
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
The participant is being informed about their allocation to the control group.

Locations

Country	Name	City	State
Denmark	University of Southern Denmark, National Institute of Public Health	Copenhagen

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 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.	Outcome measure was based on self-reported drinking during a typical week.	12 months	No