Testing the Efficacy of an Online Alcohol Intervention in a Workplace Setting

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: NCT01931618
• Other study ID #: SERAF-BALANCE-2
• Secondary ID: 142956
• Status: Completed
• Phase: N/A
• First received: August 26, 2013
• Last updated: September 7, 2017
• Start date: April 2011
• Est. completion date: November 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 - in a workplace setting - if an online multi-session alcohol intervention improves treatment effect over and above a single session screening with feedback.

Hypothesis: automated online multi-session follow-up improves the effect on alcohol consumption over and above a single session screening

Description:

Setting: Online study among Norwegian employees.

Participants: At-risk drinkers among employees in a select group of norwegian workplaces is recruited through an e-mail to their job e-mail account, and advertisements on the intranet of their organization.

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".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• 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	The 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, Johansen A, Nesvåg S, Kok G, Duckert F. Constructing a Theory- and Evidence-Based Treatment Rationale for Complex eHealth Interventions: Development of an Online Alcohol Intervention Using an Intervention Mapping Approach. JMIR Res Protoc. 2013 Jan 23;2(1):e6. doi: 10.2196/resprot.2371. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The 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.	Measured six months after enrollment/baseline
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

External Links

•   The detailed treatment rationale and description of intervention used in the current trial