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Effectiveness of Internet-based Depression Treatment (EVIDENT)

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.
 
ClinicalTrials.gov Identifier: NCT01636752
Recruitment Status : Completed
First Posted : July 10, 2012
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Philipp Klein, University of Luebeck

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Mild to Moderate Depressive Symptoms Behavioral: Deprexis Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1013 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : July 2012
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


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

Secondary Outcome Measures :
  1. Hamilton Rating Scale for Depression (HRSD) [ Time Frame: 12 wks, 6 mths, 12 mths ]
  2. Quick Inventory of Depressive Symptoms (QIDS) [ Time Frame: 12 wks, 6 mths, 12 mths ]
  3. Personal Health Questionnaire (PHQ-9) [ Time Frame: 6 mths, 12 mths ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older 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
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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
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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
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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Philipp Klein, Coordinating Investigator, University of Luebeck
ClinicalTrials.gov Identifier: NCT01636752    
Other Study ID Numbers: EVIDENT Trial
First Posted: July 10, 2012    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms