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

TY - JOUR

T1 - The EVIDENT-Trial: protocol and rationale of a multicenter randomized controlled trial testing the effectiveness of an online-based psychological intervention

AU - Klein, Jan Philipp

AU - Berger, Thomas

AU - Schröder, Johanna

AU - Späth, Christina

AU - Meyer, Björn

AU - Caspar, Franz

AU - Lutz, Wolfgang

AU - Greiner, Wolfgang

AU - Hautzinger, Martin

AU - Rose, Matthias

AU - Gräfe, Viola

AU - Hohagen, Fritz

AU - Andersson, Gerhard

AU - Vettorazzi, Eik

AU - Moritz, Steffen

PY - 2013/9/28

Y1 - 2013/9/28

N2 - 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.

AB - 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.

KW - Adult

KW - Clinical Protocols

KW - Depressive Disorder

KW - Female

KW - Humans

KW - Male

KW - Patient Satisfaction

KW - Psychotherapy

KW - Quality of Life

KW - Remote Consultation

KW - Research Design

KW - Self Care

KW - Severity of Illness Index

KW - Single-Blind Method

KW - Treatment Outcome

U2 - 10.1186/1471-244X-13-239

DO - 10.1186/1471-244X-13-239

M3 - SCORING: Journal article

C2 - 24074299

VL - 13

JO - BMC PSYCHIATRY

JF - BMC PSYCHIATRY

SN - 1471-244X

IS - 239

ER -