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

May 26, 2015 updated by: Philipp Klein, University of Luebeck
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

163

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany
        • Department of Psychiatry and Psychotherapy, University of Hamburg
      • Hamburg, Germany
        • GAIA AG
      • Luebeck, Germany
        • Department of Psychiatry and Psychotherapy, University of Luebeck
  • Switzerland
      • Bern, Switzerland
        • Department of Clinical Psychology and Psychotherapy, University of Bern

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Deprexis
Online self-help
Behavioral: Deprexis
Online self-help
Active Comparator: CAU
Care as usual
Other: CAU
Care as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Patient Health Questionnaire - 9 items (PHQ-9)
Time Frame: Change from Baseline to post (3mths).
Change from Baseline to post (3mths).

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Luebeck

Collaborators

University of Bern
University of Hamburg-Eppendorf
Björn Meyer, Gaia AG, Hamburg, Germany / Department of Psychology, City University, London, United Kingdom

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

June 25, 2014

First Submitted That Met QC Criteria

June 27, 2014

First Posted (Estimate)

July 1, 2014

Study Record Updates

Last Update Posted (Estimate)

May 27, 2015

Last Update Submitted That Met QC Criteria

May 26, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EVIDENTplus

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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