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Effectiveness of Internet-based Depression Treatment (EVIDENT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Philipp Klein, University of Luebeck
ClinicalTrials.gov Identifier:
NCT01636752
First received: July 5, 2012
Last updated: June 25, 2014
Last verified: June 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Further study details as provided by University of Luebeck:

Primary Outcome Measures:
  • Personal Health Questionnaire (PHQ-9) [ Time Frame: 12 wks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hamilton Rating Scale for Depression (HRSD) [ Time Frame: 12 wks, 6 mths, 12 mths ] [ Designated as safety issue: No ]
  • Quick Inventory of Depressive Symptoms (QIDS) [ Time Frame: 12 wks, 6 mths, 12 mths ] [ Designated as safety issue: No ]
  • Personal Health Questionnaire (PHQ-9) [ Time Frame: 6 mths, 12 mths ] [ Designated as safety issue: No ]

Estimated Enrollment: 1000
Study Start Date: July 2012
Estimated Primary Completion Date: March 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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

Additional Information:
Publications:
Responsible Party: Philipp Klein, Coordinating Investigator, University of Luebeck
ClinicalTrials.gov Identifier: NCT01636752     History of Changes
Other Study ID Numbers: EVIDENT Trial
Study First Received: July 5, 2012
Last Updated: June 25, 2014
Health Authority: Germany: Ethics Commission; Germany: Ministry of Health

ClinicalTrials.gov processed this record on November 20, 2014