Testing the Efficacy of an Online Alcohol Intervention

This study has been completed.
Sponsor:
Collaborator:
The Research Council of Norway
Information provided by (Responsible Party):
Håvar Brendryen, University of Oslo
ClinicalTrials.gov Identifier:
NCT01754090
First received: December 17, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Digital Therapy: Evaluation of the Fully Automated Alcohol Intervention "Balance".

Further study details as provided by 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) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Håvar Brendryen, Research fellow. PhD., University of Oslo
ClinicalTrials.gov Identifier: NCT01754090     History of Changes
Other Study ID Numbers: SERAF-BALANCE-1
Study First Received: December 17, 2012
Last Updated: December 17, 2012
Health Authority: Norway: Regional Ethics Commitee

Keywords provided by 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
Therapeutic Uses
Pharmacologic Actions
Central Nervous System Depressants
Physiological Effects of Drugs
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 16, 2014