NCT00100035

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2004

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 23, 2004

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

April 22, 2008

Status Verified

April 1, 2008

Enrollment Period

2.7 years

First QC Date

December 22, 2004

Last Update Submit

April 21, 2008

Conditions

StressDepressionAnxiety

Keywords

CaregiversComplementary Therapies

Outcome Measures

Primary Outcomes (1)

  • Perceived stress

Interventions

Polarity therapyPROCEDURE

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Caregiver of a family member with dementia for at least 4 hours a day
  • American Indian

You may not qualify if:

  • Nerve disorders caused by diabetes
  • Use of beta blockers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Center for World Indigenous Studies

Olympia, Washington, 98502, United States

Location

Related Links

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Leslie E. Korn, PhD, MPH

    Center for World Indigenous Studies

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

December 22, 2004

First Posted

December 23, 2004

Study Start

August 1, 2004

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

April 22, 2008

Record last verified: 2008-04

Locations

US(1)