Testing the Efficacy of an Online Alcohol Intervention

Not Applicable

Completed

• Conditions: Hazardous Drinking; Harmful Drinking
• Interventions: Behavioral: Online screening and feedback; Behavioral: Online booklet.; Behavioral: Online multi session follow-up

• Registration Number: NCT01754090
• Lead Sponsor: University of Oslo

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.

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Study First Submitted: 2012-12-17
• Study First Submitted QC: 2012-12-17
• Study First Posted: 2012-12-21
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-07
• Last Update Posted: 2017-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 244

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care	Online screening and feedback	Receives two interventions: 1. Online screening and feedback. 2. Online booklet.
Usual care	Online booklet.	Receives two interventions: 1. Online screening and feedback. 2. Online booklet.
Extended follow-up	Online screening and feedback	Receives two interventions: 1. Online screening and feedback. 2. Online multi session follow-up.
Extended follow-up	Online multi session follow-up	Receives two interventions: 1. Online screening and feedback. 2. Online multi session follow-up.

Primary Outcome Measures

Name	Time	Method
number of standard alcohol units consumed during the previous seven days	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 Outcome Measures

Name	Time	Method
Negative consequences of alcohol consumption	Assessed at six months post baseline	Perceived negative consequences of own alcohol consumption, during the seven previous days, was assessed by a 13 item index, resulting in a sum score with a theoretical range from zero to 13. The items comprised: headache, nausea, anxiety, worn out, depressed, breaking a plan, breaking a date, sick leave, memory problems, bad conscience, conflict, destroyed something and injuries.
Sick leave during last week	Assessed at six months post baseline	Sick leave was assessed with a "yes" or "no" response for each of the past seven days, and then accumulated, resulting in a score of zero to seven. Participants were instructed to report any sick leave regardless of reason.
Number of days with alcohol consumption	Six months post baseline	Based on the seven day consecutive measure (primary outcome), the number of days with alcohol consumption is calculated.
Number of alcohol binges	Six months post baseline	Based on the seven day consecutive measure (primary outcome), the number of days with a binge drinking episode is calculated.
Change in alcohol consumption	Six months post baseline	The change score for weekly consumption, from baseline to six months, is calculated based on the seven day consecutive measure (primary outcome).

Trial Locations

Locations (1)

Norwegian Centre for Addiction Research, University of Oslo; 🇳🇴 Oslo, Norway