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Completed

NCT Number: NCT02178631

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

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.

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Key information

Conditions

Severe Depressive Symptoms Behavior Behavioral Symptoms Depression

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Psychiatry and Psychotherapy, University of Hamburg, Hamburg, Germany

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Deprexis

Behavioral

Online self-help

CAU

Other

Care as usual

Primary outcomes

  1. Patient Health Questionnaire - 9 items (PHQ-9)

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

Secondary outcomes

  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)

Sponsors and collaborators

Lead sponsor

University of Luebeck

Other

Collaborators

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

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 1, 2014
Registry last updated
May 27, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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