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Effectiveness of Internet-based Depression Treatment (EVIDENT)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2015 by Philipp Klein, University of Luebeck.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01636752
First Posted: July 10, 2012
Last Update Posted: May 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Philipp Klein, University of Luebeck
  Purpose
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.

Condition Intervention
Mild to Moderate Depressive Symptoms Behavioral: Deprexis

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by Philipp Klein, University of Luebeck:

Primary Outcome Measures:
  • Personal Health Questionnaire (PHQ-9) [ Time Frame: 12 wks ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 1000
Study Start Date: July 2012
Estimated Study Completion Date: February 2017
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Deprexis
Online self-help with and without e-mail-support
Behavioral: Deprexis
Online self-help with and without e-mail-support
No Intervention: Control

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).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • PHQ>4 and <15

Exclusion Criteria:

  • acute suicidality
  • psychotic d/o, bipolar d/o or other severe psychiatric d/o
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01636752


Locations
Germany
Charité Berlin
Berlin, Germany
Universität Bielefeld
Bielefeld, Germany
Universität Hamburg
Hamburg, Germany
Universität Lübeck
Lübeck, Germany
Sponsors and Collaborators
University of Luebeck
  More Information

Publications:
Responsible Party: Philipp Klein, Coordinating Investigator, University of Luebeck
ClinicalTrials.gov Identifier: NCT01636752     History of Changes
Other Study ID Numbers: EVIDENT Trial
First Submitted: July 5, 2012
First Posted: July 10, 2012
Last Update Posted: May 27, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Depression
Behavioral Symptoms