Depression Clinical Trial
Official title:
Pilot Trial of Depression Care Management by Electronic Secure Messaging
This study will test whether an electronic system that monitors and sends messages to help people with depression could be feasible, acceptable, and potentially effective as a treatment.
Symptoms of depression, such as persistent sadness, problems sleeping, and inability to feel
pleasure, interfere with the daily lives of more than 20 million Americans. Previous research
indicates that telephone care management systems improve the quality and outcomes of
depression care, but are too expensive to be used widely. Using secure messaging over e-mail
would be more cost effective than telephone care. This study will examine whether a secure
messaging care management program would be feasible, based on whether participants are
willing to sign up for and continue with the program, and whether the program has a positive
effect on those participants enrolled in the program.
Potential participants for this study will be contacted via e-mail, with a follow-up
telephone call if they do not respond to the e-mail message. Only people who have used
e-mails in the past year and who are starting antidepressant treatment will be contacted. The
percentage of people contacted who enroll will be recorded.
Participation in this study will last 6 months. Participants will be randomly assigned to
receive either a secure messaging care management program, based on effective telephone
management programs, or their usual care with no intervention. Those receiving the secure
messaging program will receive an initial welcome message and monitoring messages
approximately 2, 6, and 10 weeks after treatment has begun. The monitoring messages will
include structured assessments of depression severity, medication adherence, medication side
effects, and barriers to continuing treatment. Participants who do not respond to monitoring
messages will receive up to two e-mailed reminders. Care managers will analyze the results of
monitoring messages, provide feedback and recommendations to physicians, coordinate physician
follow-ups, and facilitate emergency care or specialty referrals. Care managers will also
provide patients with motivation, based on semi-scripted protocols, and education concerning
their disorder and treatment. Measures of the success of the study will be taken at
enrollment and after 6 months of participation. Specific measurements will include the
response rate of recruitment e-mails, response rate for follow-up data collection, proportion
of those in the secure messaging program who complete the monitoring assessments, effects of
the program on antidepressant treatment, and effects of the program on patient satisfaction.
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