Testing the Efficacy of an Online Alcohol Intervention

• ClinicalTrials.gov Identifier: NCT01754090
• Recruitment Status: Completed
• First Posted: December 21, 2012
• Last Update Posted: September 11, 2017
• Sponsor: University of Oslo
• Collaborator: The Research Council of Norway
• Information provided by (Responsible Party): Håvar Brendryen, University of Oslo

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Hazardous Drinking; Harmful Drinking	Behavioral: Online screening and feedback; Behavioral: Online booklet.; Behavioral: Online multi session follow-up	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 244 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Digital Therapy: Evaluation of the Fully Automated Alcohol Intervention "Balance".
• Study Start Date: April 2011
• Actual Primary Completion Date: June 2012
• Actual Study Completion Date: June 2012

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Usual care; Receives two interventions: Online screening and feedback.; Online booklet.	Behavioral: Online screening and feedback; An online single session screening procedure including individualized normative feedback.; Behavioral: 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
Experimental: Extended follow-up; Receives two interventions: Online screening and feedback.; Online multi session follow-up.	Behavioral: Online screening and feedback; An online single session screening procedure including individualized normative feedback.; Behavioral: 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).

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. Sick leave during last week [ Time Frame: 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.
2. Negative consequences of alcohol consumption [ Time Frame: 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.
3. Change in alcohol consumption [ Time Frame: 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).
4. Number of days with alcohol consumption [ Time Frame: Six months post baseline ]
   Based on the seven day consecutive measure (primary outcome), the number of days with alcohol consumption is calculated.
5. Number of alcohol binges [ Time Frame: Six months post baseline ]
   Based on the seven day consecutive measure (primary outcome), the number of days with a binge drinking episode is calculated.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Norway

Norwegian Centre for Addiction Research, University of Oslo

Oslo, Norway, 0315

Sponsors and Collaborators

University of Oslo

The Research Council of Norway

Investigators

• Principal Investigator: Håvar Brendryen, PhD; Norwegian Centre for Addiction Research, University of Oslo

More Information

Publications:

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.

• Responsible Party: Håvar Brendryen, Research fellow. PhD., University of Oslo
• ClinicalTrials.gov Identifier: NCT01754090
• Other Study ID Numbers: SERAF-BALANCE-1
• First Posted: December 21, 2012
• Last Update Posted: September 11, 2017
• Last Verified: September 2017

Keywords provided by Håvar Brendryen, University of Oslo:

alcohol; online intervention; hazardous drinking; harmful drinking; early intervention; behavior change intervention