- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00380536
Medical Self-Management for Improving Health Behavior Among Individuals in Community Mental Health Settings
Adapting a Medical Self-Management Program for a Community Mental Health Center
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
People with serious mental disorders tend to have shorter life expectancies and elevated rates of unhealthy behaviors and chronic illnesses. Peer-led medical illness self-management programs have been shown to be effective in improving the health and health behaviors of people with chronic medical conditions. This type of intervention, however, has yet to be systematically tested in individuals with mental disorders. Community mental health centers provide care to many people of low socioeconomic status who lack medical insurance. This study will evaluate the effectiveness of a medical illness self-management program in improving the health and health behaviors of people who are receiving care at a community mental health center.
Participants in this study will be randomly assigned to either partake in peer-led medical illness self-management group sessions or receive care as usual. Participants assigned to care as usual will continue to receive any services they would have otherwise been offered, but will not receive any additional services through the study. Participants assigned to the medical illness self-management program will attend group sessions once a week for 6 weeks. Sessions will focus on medical self-management, healthy behaviors, and effective use of the general medical system.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Georgia
-
Decatur, Georgia, United States, 30030
- Winn Way Mental Health Center
-
Decatur, Georgia, United States, 30034
- Clifton Springs Mental Health Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Currently receiving treatment at Dekalb Community Service Board
- Chronic disease
Exclusion Criteria:
- History of more than two psychiatric or medical hospitalizations within the year prior to study entry
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: 2
Participants will receive treatment as usual.
|
|
Experimental: 1
Participants will participate in peer-led medical illness self-management group sessions.
|
Participants will participate in group sessions once a week for 6 weeks.
Sessions will focus on medical self-management, healthy behaviors, and effective use of the general medical system.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient activation
Time Frame: Measured at Months 6 and 12
|
Measured at Months 6 and 12
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Health-related quality of life
Time Frame: Measured at Months 6 and 12
|
Measured at Months 6 and 12
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Benjamin Druss, MD, MPH, Emory University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00047631
- DAHBR 96-BHB
- R34MH078583 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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