- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00056485
Treatment of Depression in Nursing Homes
Behavioral Intervention for Depression in Nursing Homes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Depression in long-term care facilities is a significant public health issue. Up to 50% of nursing home residents are affected by significant depressive symptoms. The decreased health and limited cognitive ability of many nursing home residents makes treatment and research extremely challenging. This study will attempt to identify and implement treatments for depressed nursing home residents.
Participants are randomly assigned to receive either an active intervention or treatment as usual for 6 weeks. The active intervention is followed by 4 weeks of maintenance. The intervention is implemented primarily by existing nursing facility staff and focuses on increasing opportunities for residents to experience pleasant events through increased levels of activity and positive affect. The maintenance treatment involves incorporation of protocol-based activities into patient care plans. Patients have a follow-up visit 12 weeks after the study. Psychiatric evaluations, depression and mood rating scales, observed affect and activity participation, behavior problems, and staff burden are assessed.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Kentucky
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Louisville, Kentucky, United States, 40292
- University of Louisville
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Nursing home residents
- DSM-IV criteria for major depressive disorder or dysthymia or Research Diagnostic Criteria for minor depressive disorder with current Geriatric Depression Scale scores > 11 and Mini Mental State scores >= 14
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Suzanne Meeks, PhD, University of Louisville
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 (Actual)
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
- R21MH063073 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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