Testing the Efficacy of an Online Alcohol Intervention

NCT ID: NCT01754090

Last Updated: 2017-09-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hazardous Drinking Harmful Drinking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Usual care

Receives two interventions:

1. Online screening and feedback.
2. Online booklet.

Group Type ACTIVE_COMPARATOR

Online screening and feedback

Intervention Type BEHAVIORAL

An online single session screening procedure including individualized normative feedback.

Online booklet.

Intervention Type 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

Extended follow-up

Receives two interventions:

1. Online screening and feedback.
2. Online multi session follow-up.

Group Type EXPERIMENTAL

Online screening and feedback

Intervention Type BEHAVIORAL

An online single session screening procedure including individualized normative feedback.

Online multi session follow-up

Intervention Type BEHAVIORAL

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).

Interventions

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Online screening and feedback

An online single session screening procedure including individualized normative feedback.

Intervention Type 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

Intervention Type 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).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Research Council of Norway

OTHER

Sponsor Role collaborator

University of Oslo

OTHER

Sponsor Role lead

Responsible Party

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Håvar Brendryen

Research fellow. PhD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Håvar Brendryen, PhD

Role: PRINCIPAL_INVESTIGATOR

Norwegian Centre for Addiction Research, University of Oslo

Locations

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Norwegian Centre for Addiction Research, University of Oslo

Oslo, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type BACKGROUND
PMID: 24134709 (View on PubMed)

Other Identifiers

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SERAF-BALANCE-1

Identifier Type: -

Identifier Source: org_study_id

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