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Clinical Trials/NCT01754090
NCT01754090
Completed
N/A

Digital Therapy: Evaluation of the Fully Automated Alcohol Intervention "Balance".

University of Oslo1 site in 1 country244 target enrollmentApril 2011

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hazardous Drinking
Sponsor
University of Oslo
Enrollment
244
Locations
1
Primary Endpoint
number of standard alcohol units consumed during the previous seven days
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The purpose of this study is to test whether an online multi session alcohol intervention improves treatment effect compared to single session screening with feedback only.

All participants in the trial received a single session screening procedure including individualized normative feedback (usual care). Additionally, half of the participants received a simple online booklet about the effects of alcohol. The other half received an online multi session follow up program.

Detailed Description

Aims: Test whether a multi session alcohol intervention improves treatment effect (i.e., reduced consumption of alcohol) compared to single session screening with feedback. Design: Randomized controlled trial (RCT). Subjects in both conditions receives a single session screening procedure including individualized normative feedback. The control group receives an online booklet about the effects of alcohol. The treatment group receives the multi session follow up program "Balance" . Setting: Online study in Norway. Participants: At-risk drinkers is recruited through internet advertisements and randomly assigned to one of two conditions.

Registry
clinicaltrials.gov
Start Date
April 2011
End Date
June 2012
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Håvar Brendryen

Research fellow. PhD.

University of Oslo

Eligibility Criteria

Inclusion Criteria

  • hazardous or harmful drinking (i.e., a FAST-score of 3 or more)

Exclusion Criteria

  • underage (\<18)
  • not provided a valid e-mail address
  • not provided a valid (Norwegian) mobile phone number

Outcomes

Primary Outcomes

number of standard alcohol units consumed during the previous seven days

Time Frame: measures six months after baseline (enrollment)

Subjects are asked to indicate (through online questionnaires) how many standard alcohol units they consumed on each of the previous seven days, on a scale from zero to ten. Then a sum-score for weekly consumption is calculated, ranging from zero to 70.

Secondary Outcomes

  • Negative consequences of alcohol consumption(Assessed at six months post baseline)
  • Sick leave during last week(Assessed at six months post baseline)
  • Number of days with alcohol consumption(Six months post baseline)
  • Number of alcohol binges(Six months post baseline)
  • Change in alcohol consumption(Six months post baseline)

Study Sites (1)

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