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Effectiveness of Internet-based Depression Treatment (EVIDENT) in Severe Depression

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: NCT02178631
Recruitment Status : Completed
First Posted : July 1, 2014
Last Update Posted : May 27, 2015
Sponsor:
Collaborators:
Björn Meyer, Gaia AG, Hamburg, Germany / Department of Psychology, City University, London, United Kingdom
University of Hamburg-Eppendorf
University of Bern
Information provided by (Responsible Party):
Philipp Klein, University of Luebeck

Study Description
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Brief Summary:
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 severe 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 six months period. 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
Severe Depressive Symptoms Behavioral: Deprexis Other: CAU Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 163 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : February 2013
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Deprexis
Online self-help
 Behavioral: Deprexis
Online self-help
Active Comparator: CAU
Care as usual
 Other: CAU
Care as usual


Outcome Measures
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Primary Outcome Measures :
  1. Patient Health Questionnaire - 9 items (PHQ-9) [ Time Frame: Change from Baseline to post (3mths). ]

Secondary Outcome Measures :
  1. Quick Inventory of Depressive Symptoms - Self-Rreport (QIDS-SR16) [ Time Frame: Baseline, post (3 mths), follow-up (6 mths) ]
  2. Generalized Anxiety Disorder - 7 (GAD-7) [ Time Frame: Baseline, post (3 mths), follow-up (6 mths) ]
  3. Patient Health Questionnaire - 15 items (PHQ-15) [ Time Frame: Baseline, post (3 mths), follow-up (6 mths) ]
  4. Short Form Health Survey - 12 (SF-12) [ Time Frame: Baseline, post (3 mths), follow-up (6 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:   Yes
Criteria

Inclusion Criteria:

  • Age between 18 and 65, ability to read German, willingness to participate in a telephone diagnostic interview, achieving a score of at least 15 on the PHQ-9 in an initial screening, and providing written informed consent

Exclusion Criteria:

  • Lifetime diagnosis of schizophrenia or bipolar disorder (as determined by a telephone diagnostic interview) or current suicidality (as determined in a telephone interview)
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): NCT02178631


Locations
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Germany
Department of Psychiatry and Psychotherapy, University of Hamburg
Hamburg, Germany
Gaia AG
Hamburg, Germany
Department of Psychiatry and Psychotherapy, University of Luebeck
Luebeck, Germany
Switzerland
Department of Clinical Psychology and Psychotherapy, University of Bern
Bern, Switzerland
Sponsors and Collaborators
University of Luebeck
Björn Meyer, Gaia AG, Hamburg, Germany / Department of Psychology, City University, London, United Kingdom
University of Hamburg-Eppendorf
University of Bern
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

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

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Responsible Party: Philipp Klein, Dr. med., University of Luebeck
ClinicalTrials.gov Identifier: NCT02178631    
Other Study ID Numbers: EVIDENTplus
First Posted: July 1, 2014    Key Record Dates
Last Update Posted: May 27, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Depression
Behavioral Symptoms