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


CONCLUSIONS
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.


BACKGROUND



BACKGROUND
NCT01636752.
Department of Psychiatry and Psychotherapy, Luebeck University, Luebeck, Germany. philipp.klein@uksh.de.
Jan Philipp
JP
Klein
Thomas
T
Berger
Johanna
J
Schröder
Christina
C
Späth
Björn
B
Meyer
Franz
F
Caspar
Wolfgang
W
Lutz
Wolfgang
W
Greiner
Martin
M
Hautzinger
Matthias
M
Rose
Viola
V
Gräfe
Fritz
F
Hohagen
Gerhard
G
Andersson
Eik
E
Vettorazzi
Steffen
S
Moritz
D000328:Adult; D002985:Clinical Protocols; D003866:Depressive Disorder / Q000523:psychology / Q000628:therapy*; D005260:Female; D006801:Humans; D008297:Male; D017060:Patient Satisfaction; D011613:Psychotherapy / Q000379:methods*; D011788:Quality of Life; D019114:Remote Consultation / Q000379:methods*; D012107:Research Design; D012648:Self Care; D012720:Severity of Illness Index; D016037:Single-Blind Method; D016896:Treatment Outcome