StressPhase 1NCT00100035
Polarity Therapy for American Indian Caregivers of Dementia Patients
A Phase 1 study testing Polarity therapy in people with Stress and Depression, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Depression, Anxiety
- What is being tested?
- Polarity therapy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2004to Apr 2007
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Caregiver of a family member with dementia for at least 4 hours a day
- American Indian
Who cannot join
- Nerve disorders caused by diabetes
- Use of beta blockers
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for World Indigenous Studies
Olympia, Washington, 98502
About this study
Official title: Polarity Therapy for Dementia Caregivers
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.
Read the 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.
- Conditions
- Stress, Depression, Anxiety
- Being tested
- Polarity therapy
- Keywords
- Caregivers, Complementary Therapies
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polarity therapyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived stress
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2004 (estimated)
- Study startAug 2004
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
- Investigators
- Leslie E. Korn, PhD, MPH, Principal investigator, Center for World Indigenous Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00100035
- Sponsor's protocol ID
- R21AT001627-01A1
- Status last verified
- Apr 2008
- First submitted
- 22 Dec 2004
- Last updated
- 22 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polarity Therapy for Dementia Caregivers
- ClinicalTrials.gov ID
- NCT00100035
- Acronym / sponsor ID
- R21AT001627-01A1
- Conditions
- Stress, Depression, Anxiety
- Keywords
- Caregivers, Complementary Therapies
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Aug 2004
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 23 Dec 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Caregiver of a family member with dementia for at least 4 hours a day
- American Indian
Key exclusion criteria (2 listed)
- Nerve disorders caused by diabetes
- Use of beta blockers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polarity therapy | Procedure or surgery | – |
Primary outcome
Perceived stress
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2008.
- Click here for more information about The Center for Traditional Medicine.Link provided by the sponsor.
- Click here for more information on The Center for World Indigenous Studies.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie E. Korn, PhD, MPH principal investigator
Center for World Indigenous Studies
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Polarity therapy in people with Stress and Depression, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived stress. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2008.