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Open Access Study protocol

GET.ON Mood Enhancer: efficacy of Internet-based guided self-help compared to psychoeducation for depression: an investigator-blinded randomised controlled trial

David Daniel Ebert12*, Dirk Lehr1, Harald Baumeister34, Leif Boß1, Heleen Riper156, Pim Cuijpers16, Jo Annika Reins1, Claudia Buntrock1 and Matthias Berking12

Author Affiliations

1 Leuphana University, Innovation Incubator, Division Health Trainings online, Rotenbleicher Weg 67, Lüneburg 21335, Germany

2 Philipps University Marburg, Department of Psychology; Clinical Psychology and Psychotherapy, Marburg, Germany

3 Department of Medical Psychology and Medical Sociology, Faculty of Medicine, University of Freiburg, Freiburg, Germany

4 Department of Rehabilitation Psychology and Psychotherapy, Institute of Psychology, University of Freiburg, Freiburg, Germany

5 GGZ inGeest, Regional Mental Health Service Centre, VU University Medical Centre, Amsterdam, The Netherlands

6 Department of Clinical Psychology and EMGO Institute for Health and Care Research, VU University, Amsterdam, The Netherlands

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Trials 2014, 15:39  doi:10.1186/1745-6215-15-39

Published: 30 January 2014

Abstract

Background

Major depressive disorder (MDD) imposes a considerable disease burden on individuals and societies. A large number of randomised controlled trials (RCTs) have shown the efficacy of Internet-based guided self-help interventions in reducing symptoms of depression. However, study quality varies considerably. The aim of this study is to evaluate the efficacy of a new Internet-based guided self-help intervention (GET.ON Mood Enhancer) compared to online-based psychoeducation in an investigator-blinded RCT.

Methods/design

A RCT will be conducted to compare the efficacy of GET.ON Mood Enhancer with an active control condition receiving online psychoeducation on depression (OPD). Both treatment groups will have full access to treatment as usual. Adults with MDD (n = 128) will be recruited and randomised to one of the two conditions. Primary outcome will be observer-rated depressive symptoms (HRSD-24) by independent assessors blind to treatment conditions. Secondary outcomes include changes in self-reported depressive symptom severity, anxiety and quality of life. Additionally, potential negative effects of the treatments will systematically be evaluated on several dimensions (for example, symptom deteriorations, attitudes toward seeking psychological help, relationships and stigmatisation). Assessments will take place at baseline, 6 and 12 weeks after randomisation.

Discussion

This study evaluates a new Internet-based guided self-help intervention for depression using an active control condition (psychoeducation-control) and an independent, blinded outcome evaluation. This study will further enhance the evidence for Internet-based guided self-help interventions for MDD.

Trial registration

German Clinical Trial Registration (DRKS): DRKS00005025

Keywords:
Guided self-help; Internet-based; Major depressive disorder; Randomised controlled trial; Negative effects of psychotherapy; Active control