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BMC Psychiatry
Published in: BMC Psychiatry 1/2013

Open Access 01-12-2013 | Study protocol

The EVIDENT-trial: protocol and rationale of a multicenter randomized controlled trial testing the effectiveness of an online-based psychological intervention

Authors: Jan Philipp Klein, Thomas Berger, Johanna Schröder, Christina Späth, Björn Meyer, Franz Caspar, Wolfgang Lutz, Wolfgang Greiner, Martin Hautzinger, Matthias Rose, Viola Gräfe, Fritz Hohagen, Gerhard Andersson, Eik Vettorazzi, Steffen Moritz

Published in: BMC Psychiatry | Issue 1/2013

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Abstract

Background

Depressive disorders are among the leading causes of worldwide disability with mild to moderate forms of depression being particularly common. Low-intensity treatments such as online psychological treatments may be an effective way to treat mild to moderate depressive symptoms and prevent the emergence or relapse of major depression.

Methods/Design

This study is a currently recruiting multicentre parallel-groups pragmatic randomized-controlled single-blind trial. A total of 1000 participants with mild to moderate symptoms of depression from various settings including in- and outpatient services will be randomized to an online psychological treatment or care as usual (CAU). We hypothesize that the intervention will be superior to CAU in reducing depressive symptoms assessed with the Personal Health Questionnaire (PHQ-9, primary outcome measure) following the intervention (12 wks) and at follow-up (24 and 48 wks). Further outcome parameters include quality of life, use of health care resources and attitude towards online psychological treatments.

Discussion

The study will yield meaningful answers to the question of whether online psychological treatment can contribute to the effective and efficient prevention and treatment of mild to moderate depression on a population level with a low barrier to entry.

Trial registration

Trial Registration Number: NCT01636752
Appendix
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Metadata
Title
The EVIDENT-trial: protocol and rationale of a multicenter randomized controlled trial testing the effectiveness of an online-based psychological intervention
Authors
Jan Philipp Klein
Thomas Berger
Johanna Schröder
Christina Späth
Björn Meyer
Franz Caspar
Wolfgang Lutz
Wolfgang Greiner
Martin Hautzinger
Matthias Rose
Viola Gräfe
Fritz Hohagen
Gerhard Andersson
Eik Vettorazzi
Steffen Moritz
Publication date
01-12-2013
Publisher
BioMed Central
Published in
BMC Psychiatry / Issue 1/2013
Electronic ISSN: 1471-244X
DOI
https://doi.org/10.1186/1471-244X-13-239

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