A Phase 3 interventional study of Personalised normative feedback (PNF) and Self-help material in Alcohol Abuse, sponsored by University of Southern Denmark. Completed at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-04-14.
Sponsored by University of Southern Denmark · Phase 3, Interventional, and Prevention
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.
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).
1,606 studies on the registry are indexed under Alcoholism; 329 are open to participants now.
This study's enrollment of 1,380 is above the median of 87 across 1,371 interventional studies indexed under Alcoholism.
Browse Alcoholism studies →University of Southern Denmark is the lead sponsor of 327 studies on the registry; 45 are open to participants now.
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Exclusion Criteria:
Personalized normative feedback (PFI). The PFI was a single-session intervention; it was displayed in a single screenshot and addressed the participant by name. It consisted of a summary of the participant's weekly consumption, a comparison with maximum drinking limits and a graphical comparison of the participant's consumption to the average level in the municipality (gender-specific), followed by information about health and social risks of heavy drinking as well as links for further self-help material and a local alcohol treatment facility.
Other: Personalised normative feedback (PNF)
Self-help material (SHM). The SHM was a single-session intervention and was displayed in a single screenshot. It consisted of information about maximum drinking limits, followed by information about health and social risks of heavy drinking as well as links for further standardized self-help material and a local alcohol treatment facility.
Other: Self-help material
Control
Other: Control
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.
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.
The participant is being informed about their allocation to the control group.
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.
Time frame: 12 months
This study is completed, as verified in May 2009. You cannot join it, but the record below documents what was studied.
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University of Southern Denmark