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

Not Applicable

Completed

• Conditions: Severe Depressive Symptoms
• Interventions: Behavioral: Deprexis; Other: CAU

• Registration Number: NCT02178631
• Lead Sponsor: University of Luebeck

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Study First Submitted: 2014-06-25
• Study First Submitted QC: 2014-06-27
• Study First Posted: 2014-07-01
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-26
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 163

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Deprexis	Deprexis	Online self-help
CAU	CAU	Care as usual

Primary Outcome Measures

Name	Time	Method
Patient Health Questionnaire - 9 items (PHQ-9)	Change from Baseline to post (3mths).

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (4)

Gaia AG; 🇩🇪 Hamburg, Germany

Department of Psychiatry and Psychotherapy, University of Luebeck; 🇩🇪 Luebeck, Germany

Department of Clinical Psychology and Psychotherapy, University of Bern; 🇨🇭 Bern, Switzerland

Department of Psychiatry and Psychotherapy, University of Hamburg; 🇩🇪 Hamburg, Germany