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Feasibility of Depression Care Management by E-mail

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: NCT00755235
Recruitment Status : Completed
First Posted : September 18, 2008
Results First Posted : June 1, 2012
Last Update Posted : November 13, 2017
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Kaiser Permanente

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Depression Other: Depression care management by secure messaging Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Pilot Trial of Depression Care Management by Electronic Secure Messaging
Study Start Date : April 2009
Actual Primary Completion Date : April 2010
Actual Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
Participants will receive depression care management by secure messaging.
Other: Depression care management by secure messaging
Participants will receive electronic messages welcoming them and monitoring their antidepressant treatment. Care managers will use monitoring data to aid participants' physicians, coordinate physician follow-ups, facilitate emergency care, and facilitate specialty referrals. Care managers will also provide motivation and education to participants.
Other Names:
  • online messaging
  • email

No Intervention: 2
Participants will receive their usual care, with no additional education or care management services.

Primary Outcome Measures :
  1. 20-Item Symptom Checklist Depression Scale [ Time Frame: Measured at baseline and after 6 months of treatment ]
    20-item depression severity scalse adapted from longer SCL-90. Mean score ranges from 0 to 4 with scores above 1.5 indicating moderate depression.

Secondary Outcome Measures :
  1. Treatment Satisfaction [ Time Frame: Measured after 6 months of treatment ]
    Single item seven point scale ranging from "very satisfied" to "very dissatisfied"

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patient at Capitol Hill or Rainier clinics of Group Health Cooperative in Seattle
  • New prescription of an antidepressant, defined by an interval of at least 180 days since a previous antidepressant prescription
  • Indication of depression, defined by a visit diagnosis of major depressive disorder (Internal Classification of Diseases 9th Revision [ICD9] codes 296.2x or 296.3x) within 30 days of the first prescription
  • Has used secure messaging, or e-mailing, at least twice in the last 12 months

Exclusion Criteria:

  • Any diagnosis of psychotic disorder or bipolar disorder in the prior 2 years
  • Any prescription for mood stabilizer or antipsychotic medication in the prior 2 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00755235

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United States, Washington
Group Health Cooperative Center for Health Studies
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Kaiser Permanente
National Institute of Mental Health (NIMH)
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Principal Investigator: Gregory E. Simon, MD, MPH Group Health Cooperative Center for Health Studies
Publications of Results:
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Responsible Party: Kaiser Permanente Identifier: NCT00755235    
Other Study ID Numbers: R21MH082924 ( U.S. NIH Grant/Contract )
R21MH082924 ( U.S. NIH Grant/Contract )
First Posted: September 18, 2008    Key Record Dates
Results First Posted: June 1, 2012
Last Update Posted: November 13, 2017
Last Verified: October 2017
Keywords provided by Kaiser Permanente:
Primary care
Care management
Additional relevant MeSH terms:
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Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders