eCare for Moods: An Internet-based Management Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00485420
Recruitment Status : Completed
First Posted : June 13, 2007
Last Update Posted : April 19, 2012
Eli Lilly and Company
Information provided by (Responsible Party):
Kaiser Permanente

June 11, 2007
June 13, 2007
April 19, 2012
September 2002
September 2009   (Final data collection date for primary outcome measure)
Reduction of severity of mania and depression symptoms and reduction in frequency of occurrence depression symptoms [ Time Frame: Two years ]
Reduction of mania and depression symptoms and improved functioning [ Time Frame: Two years ]
Complete list of historical versions of study NCT00485420 on Archive Site
Satisfaction with medical care [ Time Frame: Two years ]
Same as current
Not Provided
Not Provided
eCare for Moods: An Internet-based Management Program
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.

Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
  • Major Depressive Disorder
  • Bipolar Disorder
Other: Internet based disease management program
Usual Care is augmented with internet-based education, self-monitoring and clinician monitoring
Other Name: Care management via the internet
  • Active Comparator: Usual Care
    Member with recurrent or chronic depression receives usual specialty mental health care
    Intervention: Other: Internet based disease management program
  • Experimental: Internet-based disease managment program
    Usual care is augmented with internet based education, self monitoring and clinical monitoring
    Intervention: Other: Internet based disease management program
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2009
September 2009   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of bipolar or recurrent major depressive disorder and access to a computer

Exclusion Criteria:

  • No diagnosis of bipolar or recurrent major depressive disorder, no computer access
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Not Provided
Kaiser Permanente
Kaiser Permanente
Eli Lilly and Company
Principal Investigator: Enid M Hunkeler, MA Kaiser Permanente Division of Research
Kaiser Permanente
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP