Web-based Ultra-brief Intervention for Heavy Drinkers Trial

University of Southern Denmark (SDU)

Status and phase: Completed; Phase 3

Conditions: Alcohol Abuse

Treatments: Other: Control; Other: Self-help material; Other: Personalised normative feedback (PNF)

Study type: Interventional

Funder types: Other

Identifiers

NCT00751985

NIPH - 1948b

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,380 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,380 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

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.

Treatment:

Other: Personalised normative feedback (PNF)

2

Experimental group

Description:

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.

Treatment:

Other: Self-help material

3

Placebo Comparator group

Description:

Control

Treatment:

Other: Control