Testing the Efficacy of an Online Alcohol Intervention

Hazardous Drinking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01754090
• Other study ID #: SERAF-BALANCE-1
• Status: Completed
• Phase: N/A
• First received: December 17, 2012
• Last updated: September 7, 2017
• Start date: April 2011
• Est. completion date: June 2012

Study information

• Verified date: September 2017
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 244
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Harmful Drinking
• Hazardous Drinking

Intervention

Behavioral:
• Online screening and feedback
An online single session screening procedure including individualized normative feedback.
• Online booklet.
An online booklet that covers general information about alcohol, its effect on the brain and the body, potential risks and harms of drinking, and an account of the threshold values of sensible drinking
• Online multi session follow-up
An online multi session follow-up program (i.e., "Balance"). The central concept of Balance is to support continued self-regulation throughout the behavior change process. There are four key aspects of the program, the first is focus on goal setting and tracking of alcohol consumption on a day-to-day basis. The second on relapse prevention - for example, when clients report drinking more than their target, they receive individualized content aimed at preventing a full blown relapse. The third is emotion regulation, where content and assignments from positive psychology and from cognitive behavioral therapy are used. Finally, intervention covers alcohol education (i.e. the same topics as in the booklet provided to the control group).

Locations

Country	Name	City	State
Norway	Norwegian Centre for Addiction Research, University of Oslo	Oslo

Sponsors (2)

Lead Sponsor	Collaborator
University of Oslo	The Research Council of Norway

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Brendryen H, Lund IO, Johansen AB, Riksheim M, Nesvåg 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of standard alcohol units consumed during the previous seven days	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.	measures six months after baseline (enrollment)
Secondary	Sick leave during last week	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.	Assessed at six months post baseline
Secondary	Negative consequences of alcohol consumption	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.	Assessed at six months post baseline
Secondary	Change in alcohol consumption	The change score for weekly consumption, from baseline to six months, is calculated based on the seven day consecutive measure (primary outcome).	Six months post baseline
Secondary	Number of days with alcohol consumption	Based on the seven day consecutive measure (primary outcome), the number of days with alcohol consumption is calculated.	Six months post baseline
Secondary	Number of alcohol binges	Based on the seven day consecutive measure (primary outcome), the number of days with a binge drinking episode is calculated.	Six months post baseline

External Links

•   Web page of PI