Back to resultsEffectiveness of Internet-based Depression Treatment (EVIDENT) in Severe Depression
Primary Purpose
Severe Depressive Symptoms
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Deprexis
CAU
Sponsored by
About this trial
This is an interventional treatment trial for Severe Depressive Symptoms
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)
Sites / Locations
- Department of Psychiatry and Psychotherapy, University of Hamburg
- Gaia AG
- Department of Psychiatry and Psychotherapy, University of Luebeck
- Department of Clinical Psychology and Psychotherapy, University of Bern
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Deprexis
CAU
Arm Description
Online self-help
Care as usual
Outcomes
Primary Outcome Measures
Patient Health Questionnaire - 9 items (PHQ-9)
Secondary Outcome Measures
Quick Inventory of Depressive Symptoms - Self-Rreport (QIDS-SR16)
Generalized Anxiety Disorder - 7 (GAD-7)
Patient Health Questionnaire - 15 items (PHQ-15)
Short Form Health Survey - 12 (SF-12)
Full Information
NCT ID
NCT02178631
First Posted
June 25, 2014
Last Updated
May 26, 2015
Sponsor
University of Luebeck
Collaborators
Björn Meyer, Gaia AG, Hamburg, Germany / Department of Psychology, City University, London, United Kingdom, University of Hamburg-Eppendorf, University of Bern
1. Study Identification
Unique Protocol Identification Number
NCT02178631
Brief Title
Effectiveness of Internet-based Depression Treatment (EVIDENT) in Severe Depression
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Luebeck
Collaborators
Björn Meyer, Gaia AG, Hamburg, Germany / Department of Psychology, City University, London, United Kingdom, University of Hamburg-Eppendorf, University of Bern
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Depressive Symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
163 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Deprexis
Arm Type
Experimental
Arm Description
Online self-help
Arm Title
CAU
Arm Type
Active Comparator
Arm Description
Care as usual
Intervention Type
Behavioral
Intervention Name(s)
Deprexis
Intervention Description
Online self-help
Intervention Type
Other
Intervention Name(s)
CAU
Intervention Description
Care as usual
Primary Outcome Measure Information:
Title
Patient Health Questionnaire - 9 items (PHQ-9)
Time Frame
Change from Baseline to post (3mths).
Secondary Outcome Measure Information:
Title
Quick Inventory of Depressive Symptoms - Self-Rreport (QIDS-SR16)
Time Frame
Baseline, post (3 mths), follow-up (6 mths)
Title
Generalized Anxiety Disorder - 7 (GAD-7)
Time Frame
Baseline, post (3 mths), follow-up (6 mths)
Title
Patient Health Questionnaire - 15 items (PHQ-15)
Time Frame
Baseline, post (3 mths), follow-up (6 mths)
Title
Short Form Health Survey - 12 (SF-12)
Time Frame
Baseline, post (3 mths), follow-up (6 mths)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Facility Information:
Facility Name
Department of Psychiatry and Psychotherapy, University of Hamburg
City
Hamburg
Country
Germany
Facility Name
Gaia AG
City
Hamburg
Country
Germany
Facility Name
Department of Psychiatry and Psychotherapy, University of Luebeck
City
Luebeck
Country
Germany
Facility Name
Department of Clinical Psychology and Psychotherapy, University of Bern
City
Bern
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
24074299
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.
Results Reference
background
PubMed Identifier
33959044
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.
Results Reference
derived
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Effectiveness of Internet-based Depression Treatment (EVIDENT) in Severe Depression
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