Overview

This trial is active, not recruiting.

Condition mild to moderate depressive symptoms
Treatment deprexis
Sponsor University of Luebeck
Start date July 2012
End date February 2015
Trial size 1000 participants
Trial identifier NCT01636752, EVIDENT Trial

Summary

Care for people suffering from depressive symptoms should be given in a step-wise approach. One first step can be the provision of self-help material. Online self-help is an innovative way of providing self-help. The investigators want to study the effect of an interactive online self-help-program (Deprexis) in the treatment of mild to moderate depressive symptoms. Participants will be randomised to either twelve weeks of online-self help or a waiting-list control. Symptoms of depression and other aspects will be assessed over a one year period. Thereafter the controls will also receive online-self help. The investigators hypothesise that online self-help is superior to the control condition in alleviating depressive symptoms and preventing full blown depression.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Online self-help with and without e-mail-support
deprexis
Online self-help with and without e-mail-support
(No Intervention)

Primary Outcomes

Measure
Personal Health Questionnaire (PHQ-9)
time frame: 12 wks

Secondary Outcomes

Measure
Hamilton Rating Scale for Depression (HRSD)
time frame: 12 wks, 6 mths, 12 mths
Quick Inventory of Depressive Symptoms (QIDS)
time frame: 12 wks, 6 mths, 12 mths
Personal Health Questionnaire (PHQ-9)
time frame: 6 mths, 12 mths

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: - PHQ>4 and <15 Exclusion Criteria: - acute suicidality - psychotic d/o, bipolar d/o or other severe psychiatric d/o

Additional Information

Description This study is supported by the German Ministry of Health (BMG) and is a collaborative project of Universität Bern (PD Dr. Thomas Berger), Charité Berlin (PD Dr. Matthias Rose), Universität Bielefeld (Prof. Dr. Wolfgang Greiner), Universität Hamburg (Prof. Dr. Steffen Moritz, Prof. Dr. Bernd Löwe), GAIA AG Hamburg (Dr. Björn Meyer), Universität Tübingen (Prof. Dr. Martin Hautzinger) and Universität Trier (Prof. Dr. Wolfgang Lutz).
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by University of Luebeck.