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

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, 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

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 number: NCT01636752.

Figures

Figure 1
Figure 1
Diagram of patient flow through the phases of study[28].

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Source: PubMed

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