Web-based Ultra-brief Intervention for Heavy Drinkers Trial

This study has been completed.
Sponsor:
Collaborator:
National Board of Health, Denmark
Information provided by:
University of Southern Denmark
ClinicalTrials.gov Identifier:
NCT00751985
First received: September 11, 2008
Last updated: April 13, 2011
Last verified: May 2009
  Purpose

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.


Condition Intervention Phase
Alcohol Abuse
Other: Personalised normative feedback (PNF)
Other: Self-help material
Other: Control
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Web-based Ultra-brief Intervention for Heavy Drinkers - a Randomized Controlled Trial Comparing Personalized Normative Feedback With Self-help Material

Resource links provided by NLM:


Further study details as provided by University of Southern Denmark:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Outcome measure was based on self-reported drinking during a typical week.


Enrollment: 1380
Study Start Date: September 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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)

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.

Experimental: 2
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

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.

Placebo Comparator: 3
Control
Other: Control
The participant is being informed about their allocation to the control group.

Detailed 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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00751985

Locations
Denmark
University of Southern Denmark, National Institute of Public Health
Copenhagen, Denmark, 1399
Sponsors and Collaborators
University of Southern Denmark
National Board of Health, Denmark
Investigators
Principal Investigator: Anders B. Gottlieb Hansen, Ph.d.-student, cand.techn.soc University of Southern Denmark, National Institute of Public Health
  More Information

No publications provided by University of Southern Denmark

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kit Broholm, National Board of Health Denmark
ClinicalTrials.gov Identifier: NCT00751985     History of Changes
Other Study ID Numbers: NIPH - 1948b
Study First Received: September 11, 2008
Last Updated: April 13, 2011
Health Authority: Denmark: Danish Dataprotection Agency

Keywords provided by University of Southern Denmark:
Heavy drinking
Ultra-brief intervention
Brief intervention
Alcohol prevention
Randomized trial
Personal normative feedback
Self-help material
Web-based
Intervention Studies
prevention & control

Additional relevant MeSH terms:
Alcoholic Intoxication
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 16, 2014