The EVIDENT-trial

Protocol and rationale of a multicenter randomized controlled trial testing the effectiveness of an online-based psychological intervention

Jan P. 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

*Corresponding author for this work

Research output: Contribution to journalArticle

38 Citations (Scopus)

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.

Original languageEnglish
Article number239
Pages (from-to)1-10
Number of pages10
JournalBMC Psychiatry
Volume13
DOIs
Publication statusPublished - 28 Sep 2013
Externally publishedYes

Bibliographical note

Copyright the Author(s) 2013. Version archived for private and non-commercial use with the permission of the author/s and according to publisher conditions. For further rights please contact the publisher.

Keywords

  • Cost-of-illness analysis
  • Guided self-help
  • Health economic evaluation
  • Major depression
  • Online psychological treatment
  • Prevention
  • Randomized controlled trial
  • Self-help
  • Subclinical depression
  • Treatment

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