Effectiveness of Internet-based Depression Treatment (EVIDENT)

October 9, 2018 updated by: Philipp Klein, University of Luebeck
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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).

Study Type

Interventional

Enrollment (Actual)

1013

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Berlin, Germany
        • Charite Berlin
      • Bielefeld, Germany
        • Universität Bielefeld
      • Hamburg, Germany
        • Universität Hamburg
      • Lübeck, Germany
        • Universität Lübeck

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • PHQ>4 and <15

Exclusion Criteria:

  • acute suicidality
  • psychotic d/o, bipolar d/o or other severe psychiatric d/o

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Experimental: Deprexis
Online self-help with and without e-mail-support
Behavioral: Deprexis
Online self-help with and without e-mail-support

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Personal Health Questionnaire (PHQ-9)
Time Frame: 12 wks
12 wks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Luebeck

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

July 5, 2012

First Submitted That Met QC Criteria

July 5, 2012

First Posted (Estimate)

July 10, 2012

Study Record Updates

Last Update Posted (Actual)

October 12, 2018

Last Update Submitted That Met QC Criteria

October 9, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EVIDENT Trial

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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