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Clinical Trials/NCT02178631
NCT02178631
Completed
Not Applicable

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

University of Luebeck4 sites in 2 countries163 target enrollmentFebruary 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Severe Depressive Symptoms
Sponsor
University of Luebeck
Enrollment
163
Locations
4
Primary Endpoint
Patient Health Questionnaire - 9 items (PHQ-9)
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2013
End Date
May 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Luebeck
Responsible Party
Principal Investigator
Principal Investigator

Philipp Klein

Dr. med.

University of Luebeck

Eligibility 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)

Outcomes

Primary Outcomes

Patient Health Questionnaire - 9 items (PHQ-9)

Time Frame: Change from Baseline to post (3mths).

Secondary Outcomes

  • Quick Inventory of Depressive Symptoms - Self-Rreport (QIDS-SR16)(Baseline, post (3 mths), follow-up (6 mths))
  • Generalized Anxiety Disorder - 7 (GAD-7)(Baseline, post (3 mths), follow-up (6 mths))
  • Patient Health Questionnaire - 15 items (PHQ-15)(Baseline, post (3 mths), follow-up (6 mths))
  • Short Form Health Survey - 12 (SF-12)(Baseline, post (3 mths), follow-up (6 mths))

Study Sites (4)

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