Ignite Creation Date:
2025-12-24 @ 10:30 PM
Ignite Modification Date:
2025-12-31 @ 9:25 PM
Study NCT ID:
NCT00100035
Status:
COMPLETED
Last Update Posted:
2008-04-22
First Post:
2004-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Polarity Therapy for American Indian Caregivers of Dementia Patients
Sponsor:
National Center for Complementary and Integrative Health (NCCIH)
Organization:
Study Overview
Official Title:
Polarity Therapy for Dementia Caregivers
Status:
COMPLETED
Status Verified Date:
2008-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to assess the effectiveness of polarity therapy (PT), a complementary and alternative medicine treatment, in American Indian caregivers living in the Pacific Northwest.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: