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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-04-21', 'studyFirstSubmitDate': '2004-12-22', 'studyFirstSubmitQcDate': '2004-12-22', 'lastUpdatePostDateStruct': {'date': '2008-04-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perceived stress'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Caregivers', 'Complementary Therapies'], 'conditions': ['Stress', 'Depression', 'Anxiety']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.centerfortraditionalmedicine.org', 'label': 'Click here for more information about The Center for Traditional Medicine.'}, {'url': 'http://www.cwis.org', 'label': 'Click here for more information on The Center for World Indigenous Studies.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nParticipants 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Caregiver of a family member with dementia for at least 4 hours a day\n* American Indian\n\nExclusion Criteria:\n\n* Nerve disorders caused by diabetes\n* Use of beta blockers'}, 'identificationModule': {'nctId': 'NCT00100035', 'briefTitle': 'Polarity Therapy for American Indian Caregivers of Dementia Patients', 'organization': {'class': 'NIH', 'fullName': 'National Center for Complementary and Integrative Health (NCCIH)'}, 'officialTitle': 'Polarity Therapy for Dementia Caregivers', 'orgStudyIdInfo': {'id': 'R21AT001627-01A1', 'link': 'https://reporter.nih.gov/quickSearch/R21AT001627-01A1', 'type': 'NIH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Polarity therapy', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '98502', 'city': 'Olympia', 'state': 'Washington', 'country': 'United States', 'facility': 'Center for World Indigenous Studies', 'geoPoint': {'lat': 47.04491, 'lon': -122.90169}}], 'overallOfficials': [{'name': 'Leslie E. Korn, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Center for World Indigenous Studies'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Center for Complementary and Integrative Health (NCCIH)', 'class': 'NIH'}}}}