NCT01754090

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
244

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 17, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 21, 2012

Completed
Last Updated

September 11, 2017

Status Verified

September 1, 2017

Enrollment Period

1.2 years

First QC Date

December 17, 2012

Last Update Submit

September 7, 2017

Conditions

Hazardous DrinkingHarmful Drinking

Keywords

alcoholonline interventionhazardous drinkingharmful drinkingearly interventionbehavior change intervention

Outcome Measures

Primary Outcomes (1)

  • 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.

    measures six months after baseline (enrollment)

Secondary Outcomes (5)

  • Sick leave during last week

    Assessed at six months post baseline

  • Negative consequences of alcohol consumption

    Assessed at six months post baseline

  • Change in alcohol consumption

    Six months post baseline

  • Number of days with alcohol consumption

    Six months post baseline

  • Number of alcohol binges

    Six months post baseline

Study Arms (2)

Usual care

ACTIVE COMPARATOR

Receives two interventions: 1. Online screening and feedback. 2. Online booklet.

Behavioral: Online screening and feedbackBehavioral: Online booklet.

Extended follow-up

EXPERIMENTAL

Receives two interventions: 1. Online screening and feedback. 2. Online multi session follow-up.

Behavioral: Online screening and feedbackBehavioral: Online multi session follow-up

Interventions

Online screening and feedbackBEHAVIORAL

An online single session screening procedure including individualized normative feedback.

Extended follow-upUsual care
Online booklet.BEHAVIORAL

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

Usual care
Online multi session follow-upBEHAVIORAL

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).

Extended follow-up

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hazardous or harmful drinking (i.e., a FAST-score of 3 or more)

You may not qualify if:

  • underage (\<18)
  • not provided a valid e-mail address
  • not provided a valid (Norwegian) mobile phone number

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Norwegian Centre for Addiction Research, University of Oslo

Oslo, 0315, Norway

Location

Related Publications (1)

  • Brendryen H, Lund IO, Johansen AB, Riksheim M, Nesvag 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.

    PMID: 24134709BACKGROUND

Study Officials

  • Håvar Brendryen, PhD

    Norwegian Centre for Addiction Research, University of Oslo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research fellow. PhD.

Study Record Dates

First Submitted

December 17, 2012

First Posted

December 21, 2012

Study Start

April 1, 2011

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

September 11, 2017

Record last verified: 2017-09

Locations

NO(1)