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Testing the Efficacy of an Online Alcohol Intervention

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01754090
First Posted: December 21, 2012
Last Update Posted: September 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Research Council of Norway
Information provided by (Responsible Party):
Håvar Brendryen, University of Oslo
  Purpose

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 Intervention
Hazardous Drinking Harmful Drinking Behavioral: Online screening and feedback Behavioral: Online booklet. Behavioral: Online multi session follow-up

Study Type: Interventional
Study Design: 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".

Further study details as provided by Håvar Brendryen, University of Oslo:

Primary Outcome Measures:
  • 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:
  • 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.

  • 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.

  • 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).

  • 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.

  • 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.


Enrollment: 244
Study Start Date: April 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Usual care

Receives two interventions:

  1. Online screening and feedback.
  2. 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:

  1. Online screening and feedback.
  2. 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).

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01754090


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

Additional Information:
Publications:
Responsible Party: Håvar Brendryen, Research fellow. PhD., University of Oslo
ClinicalTrials.gov Identifier: NCT01754090     History of Changes
Other Study ID Numbers: SERAF-BALANCE-1
First Submitted: December 17, 2012
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

Additional relevant MeSH terms:
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs