Polarity Therapy for American Indian Caregivers of Dementia Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00100035
Recruitment Status : Completed
First Posted : December 23, 2004
Last Update Posted : April 22, 2008
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

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.

Condition or disease Intervention/treatment Phase
Stress Depression Anxiety Procedure: Polarity therapy Phase 1

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 : Interventional  (Clinical Trial)
Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Polarity Therapy for Dementia Caregivers
Study Start Date : August 2004
Actual Primary Completion Date : April 2007
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia
U.S. FDA Resources

Primary Outcome Measures :
  1. Perceived stress

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   35 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00100035

United States, Washington
Center for World Indigenous Studies
Olympia, Washington, United States, 98502
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Leslie E. Korn, PhD, MPH Center for World Indigenous Studies

Additional Information: Identifier: NCT00100035     History of Changes
Other Study ID Numbers: R21AT001627-01A1 ( U.S. NIH Grant/Contract )
First Posted: December 23, 2004    Key Record Dates
Last Update Posted: April 22, 2008
Last Verified: April 2008

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
Complementary Therapies

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders