Major Depressive Disorder Clinical Trial
Official title:
Using the Internet to Provide Disease Management and Improve Compliance Among Bipolar and Depressed Patients
The study aim is to explore the effect of a comprehensive Internet-based disease management program for bipolar disorder and recurrent or chronic major depression on clinical outcomes and satisfaction with care.
This study is a randomized controlled trial that includes 404 subjects, 300 subjects with
bipolar disorder and 104 subjects with recurrent or chronic major depressive disorder. The
study subject diagnostic groups (bipolar and depressive) are separately randomized to either
usual care or to eCare and the data collected from the two diagnostic groups are analyzed
separately.
All subjects randomized to the eCare intervention are assigned an eCare nurse care manager
in addition to one year of access to an Internet-delivered care management and patient
self-management program. While both diagnostic groups receive similar Internet-delivered
services for depression, the subjects with bipolar disorder receive special services for
bipolar disorder. All subjects randomized to usual care will receive their normal
psychiatric care and do not have access to the website.
Study subjects are followed for 24 months and outcome measurements are taken every six
months by telephone interviewers blinded to treatment assignment. Specific measures include
depression and mania symptoms, severity, adherence with medication, general health,
functioning at work and at home, satisfaction with care, and confidence in coping with their
disorder. The primary outcomes for patients with bipolar disorder are the severity of
depression and the severity of mania over time. The primary outcome for patients with
recurrent or chronic depression is the severity of depression over time. The hypothesis is
that Internet-based care management will have a favorable effect on the burden of bipolar
disorder and/or on recurrent/chronic depression over time.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research
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