Web-based Ultra-brief Intervention for Heavy Drinkers Trial

NCT00751985 | Completed Phase 3 DMC

• 1 other identifier: NIPH - 1948b
• Study Type: interventional
• Target: 1,380
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alcohol Abuse

Keywords

Heavy drinking; Ultra-brief intervention; Brief intervention; Alcohol prevention; Randomized trial; Personal normative feedback; Self-help material; Web-based; Intervention Studies; prevention & control

Outcome Measures

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.

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

  12 months

Study Arms (3)

1

EXPERIMENTAL

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)

2

EXPERIMENTAL

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

3

PLACEBO COMPARATOR

Control

Other: Control

Interventions

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.

1

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.

2

Control OTHER

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

3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Southern Denmark: lead
• National Board of Health, Denmark: collaborator

Study Sites (1)

University of Southern Denmark, National Institute of Public Health

Copenhagen, 1399, Denmark

Location

Related Publications (1)

• Hansen AB, Becker U, Nielsen AS, Gronbaek M, Tolstrup JS, Thygesen LC. Internet-based brief personalized feedback intervention in a non-treatment-seeking population of adult heavy drinkers: a randomized controlled trial. J Med Internet Res. 2012 Jul 30;14(4):e98. doi: 10.2196/jmir.1883.

  PMID: 22846542 DERIVED

MeSH Terms

Conditions

Alcoholism

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Anders B. Gottlieb Hansen, Ph.d.-student, cand.techn.soc

  University of Southern Denmark, National Institute of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 11, 2008
• First Posted: September 12, 2008
• Study Start: September 1, 2008
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: April 14, 2011

Record last verified: 2009-05

Locations

DK (1)