- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00100035
Polarity Therapy for American Indian Caregivers of Dementia Patients
Polarity Therapy for Dementia Caregivers
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The caregivers of people with dementia experience high levels of stress and are at particularly high risk for physical and mental illness. Although stress and illness are serious problems among American Indian caregivers in the Northwest, few studies have concentrated on this population. PT is a treatment that involves awareness of one's energy field and touch therapy; it has been shown to provide several physiological, biological, and psychological benefits. This study will determine whether PT is more effective than respite from caregiving in reducing stress, anxiety, and depression and improving health function and overall quality of life in American Indian caregivers.
Participants will be randomly assigned to receive either eight weekly sessions of PT or 3 hours of weekly respite from caregiving for 8 weeks. At the beginning of the study and at Weeks 4 and 8, participants will complete questionnaires and self-report scales on stress, anxiety, depression, and quality of life. In addition, heart rate variability and levels of cortisol will be measured at study entry and Weeks 4 and 8.
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
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Washington
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Olympia, Washington, United States, 98502
- Center for World Indigenous Studies
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Caregiver of a family member with dementia for at least 4 hours a day
- American Indian
Exclusion Criteria:
- Nerve disorders caused by diabetes
- Use of beta blockers
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Perceived stress
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Collaborators and Investigators
Investigators
- Principal Investigator: Leslie E. Korn, PhD, MPH, Center for World Indigenous Studies
Publications and helpful links
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
- R21AT001627-01A1 (U.S. NIH Grant/Contract)
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