Severe Depressive Symptoms Clinical Trial
| Verified date | May 2015 |
| Source | University of Luebeck |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Germany: Ethics Commission |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 163 |
| Est. completion date | May 2014 |
| Est. primary completion date | May 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 65 Years |
| Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Germany | Department of Psychiatry and Psychotherapy, University of Hamburg | Hamburg | |
| Germany | Gaia AG | Hamburg | |
| Germany | Department of Psychiatry and Psychotherapy, University of Luebeck | Luebeck | |
| Switzerland | Department of Clinical Psychology and Psychotherapy, University of Bern | Bern |
| Lead Sponsor | Collaborator |
|---|---|
| University of Luebeck | Björn Meyer, Gaia AG, Hamburg, Germany / Department of Psychology, City University, London, United Kingdom, University of Bern, University of Hamburg |
Germany, Switzerland,
Klein JP, Berger T, Schröder J, Späth C, Meyer B, Caspar F, Lutz W, Greiner W, Hautzinger M, Rose M, Gräfe V, Hohagen F, Andersson G, Vettorazzi E, Moritz S. The EVIDENT-trial: protocol and rationale of a multicenter randomized controlled trial testing the effectiveness of an online-based psychological intervention. BMC Psychiatry. 2013 Sep 28;13:239. doi: 10.1186/1471-244X-13-239. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Patient Health Questionnaire - 9 items (PHQ-9) | Change from Baseline to post (3mths). | No | |
| Secondary | Quick Inventory of Depressive Symptoms - Self-Rreport (QIDS-SR16) | Baseline, post (3 mths), follow-up (6 mths) | No | |
| Secondary | Generalized Anxiety Disorder - 7 (GAD-7) | Baseline, post (3 mths), follow-up (6 mths) | No | |
| Secondary | Patient Health Questionnaire - 15 items (PHQ-15) | Baseline, post (3 mths), follow-up (6 mths) | No | |
| Secondary | Short Form Health Survey - 12 (SF-12) | Baseline, post (3 mths), follow-up (6 mths) | No |