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Polarity Therapy for American Indian Caregivers of Dementia Patients

Primary Purpose

Stress, Depression, Anxiety

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Polarity therapy
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stress focused on measuring Caregivers, Complementary Therapies

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Center for World Indigenous Studies

Outcomes

Primary Outcome Measures

Perceived stress

Secondary Outcome Measures

Full Information

First Posted
December 22, 2004
Last Updated
April 21, 2008
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00100035
Brief Title
Polarity Therapy for American Indian Caregivers of Dementia Patients
Official Title
Polarity Therapy for Dementia Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Depression, Anxiety
Keywords
Caregivers, Complementary Therapies

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Polarity therapy
Primary Outcome Measure Information:
Title
Perceived stress

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leslie E. Korn, PhD, MPH
Organizational Affiliation
Center for World Indigenous Studies
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for World Indigenous Studies
City
Olympia
State/Province
Washington
ZIP/Postal Code
98502
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.centerfortraditionalmedicine.org
Description
Click here for more information about The Center for Traditional Medicine.
URL
http://www.cwis.org
Description
Click here for more information on The Center for World Indigenous Studies.

Learn more about this trial

Polarity Therapy for American Indian Caregivers of Dementia Patients

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