Clinical trial NCT01754090: Testing the Efficacy of an Online Alcohol Intervention
Official title: Digital Therapy: Evaluation of the Fully Automated Alcohol Intervention "Balance".
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hazardous Drinking
Harmful Drinking
Keywords: alcohol
online intervention
hazardous drinking
harmful drinking
early intervention
behavior change intervention
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
First posted: 2012-12-21
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: number of standard alcohol units consumed during the previous seven days
timeFrame: measures six months after baseline (enrollment)
Secondary outcomes:
measure: Sick leave during last week
timeFrame: Assessed at six months post baseline
measure: Negative consequences of alcohol consumption
timeFrame: Assessed at six months post baseline
measure: Change in alcohol consumption
timeFrame: Six months post baseline
measure: Number of days with alcohol consumption
timeFrame: Six months post baseline
measure: Number of alcohol binges
timeFrame: Six months post baseline
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Norwegian Centre for Addiction Research, University of Oslo
Study officials:
affiliation: Norwegian Centre for Addiction Research, University of Oslo
name: Håvar Brendryen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brendryen H, Lund IO, Johansen AB, Riksheim M, Nesvag S, Duckert F. Balance--a pragmatic randomized controlled trial of an online intensive self-help alcohol intervention. Addiction. 2014 Feb;109(2):218-26. doi: 10.1111/add.12383. Epub 2013 Nov 21.