Clinical trial NCT02178631: Effectiveness of Internet-based Depression Treatment (EVIDENT) in Severe Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Severe Depressive Symptoms
Lead sponsor: University of Luebeck
Sponsor class: OTHER
Collaborators: name: Björn Meyer, Gaia AG, Hamburg, Germany / Department of Psychology, City University, London, United Kingdom
name: University of Hamburg-Eppendorf
name: University of Bern
First posted: 2014-07-01
Enrollment: 163
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Patient Health Questionnaire - 9 items (PHQ-9)
timeFrame: Change from Baseline to post (3mths).
Secondary outcomes:
measure: Quick Inventory of Depressive Symptoms - Self-Rreport (QIDS-SR16)
timeFrame: Baseline, post (3 mths), follow-up (6 mths)
measure: Generalized Anxiety Disorder - 7 (GAD-7)
timeFrame: Baseline, post (3 mths), follow-up (6 mths)
measure: Patient Health Questionnaire - 15 items (PHQ-15)
timeFrame: Baseline, post (3 mths), follow-up (6 mths)
measure: Short Form Health Survey - 12 (SF-12)
timeFrame: Baseline, post (3 mths), follow-up (6 mths)
Other outcomes:
Locations:
city: Hamburg
country: Germany
facility: Department of Psychiatry and Psychotherapy, University of Hamburg
city: Hamburg
country: Germany
facility: Gaia AG
city: Luebeck
country: Germany
facility: Department of Psychiatry and Psychotherapy, University of Luebeck
city: Bern
country: Switzerland
facility: Department of Clinical Psychology and Psychotherapy, University of Bern
Study officials:
References:
citation: Klein JP, Berger T, Schroder J, Spath C, Meyer B, Caspar F, Lutz W, Greiner W, Hautzinger M, Rose M, Grafe 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.
citation: Kaiser T, Boschloo L, Berger T, Meyer B, Spath-Nellissen C, Schroder J, Hohagen F, Moritz S, Klein JP. Maintaining Outcomes of Internet-Delivered Cognitive-Behavioral Therapy for Depression: A Network Analysis of Follow-Up Effects. Front Psychiatry. 2021 Apr 20;12:598317. doi: 10.3389/fpsyt.2021.598317. eCollection 2021.