Testing the Efficacy of an Online Alcohol Intervention

September 7, 2017 updated by: Håvar Brendryen, University of Oslo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

244

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway, 0315
        • Norwegian Centre for Addiction Research, University of Oslo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
measures six months after baseline (enrollment)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessed at six months post baseline
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.
Assessed at six months post baseline
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).
Six months post baseline
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.
Six months post baseline
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.
Six months post baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oslo

Collaborators

The Research Council of Norway

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

December 17, 2012

First Submitted That Met QC Criteria

December 17, 2012

First Posted (ESTIMATE)

December 21, 2012

Study Record Updates

Last Update Posted (ACTUAL)

September 11, 2017

Last Update Submitted That Met QC Criteria

September 7, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SERAF-BALANCE-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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