Effectiveness of Internet-based Depression Treatment

Mild to Moderate Depressive Symptoms Clinical Trial

— EVIDENT  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01636752
• Other study ID #: EVIDENT Trial
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: February 2017

Study information

• Verified date: October 2018
• Source: University of Luebeck
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1013
• Est. completion date: February 2017
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• PHQ>4 and <15

Exclusion Criteria:

• acute suicidality

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

Related Conditions & MeSH terms

• Depression
• Mild to Moderate Depressive Symptoms

Intervention

Behavioral:
• Deprexis
Online self-help with and without e-mail-support

Locations

Country	Name	City	State
Germany	Charité Berlin	Berlin
Germany	Universität Bielefeld	Bielefeld
Germany	Universität Hamburg	Hamburg
Germany	Universität Lübeck	Lübeck

Sponsors (1)

Lead Sponsor	Collaborator
University of Luebeck

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Klein JP, Berger T, Schröder J, Späth C, Meyer B, Caspar F, Lutz W, Arndt A, Greiner W, Gräfe V, Hautzinger M, Fuhr K, Rose M, Nolte S, Löwe B, Anderssoni G, Vettorazzi E, Moritz S, Hohagen F. Effects of a Psychological Internet Intervention in the Treatm — View Citation

Klein JP, Berger T, Schröder J, Späth C, Meyer B, Caspar F, Lutz W, Greiner W, Hautzinger M, Rose M, Gräfe V, Hohagen F, Andersson G, Vettorazzi E, Moritz S. The EVIDENT-trial: protocol and rationale of a multicenter randomized controlled trial testing the effectiveness of an online-based psychological intervention. BMC Psychiatry. 2013 Sep 28;13:239. doi: 10.1186/1471-244X-13-239. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Personal Health Questionnaire (PHQ-9)		12 wks
Secondary	Hamilton Rating Scale for Depression (HRSD)		12 wks, 6 mths, 12 mths
Secondary	Quick Inventory of Depressive Symptoms (QIDS)		12 wks, 6 mths, 12 mths
Secondary	Personal Health Questionnaire (PHQ-9)		6 mths, 12 mths