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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00615082 |
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Date of registration:
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01/02/2008 |
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Primary sponsor: |
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Public title:
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The Balance Study Balancing Life and Reducing Stress For Those Providing Elder Care
Balance |
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Scientific title:
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Stress Reduction for Caregivers: A Randomized Controlled Pilot Study |
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Date of first enrolment:
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February 2007 |
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Target sample size:
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78 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00615082 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
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Countries of recruitment
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United States
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Contacts
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Name:
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Robin Whitebird, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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HealthPartners Institute for Education and Research |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- adult, 21 or older
- caregiver for a community dwelling patient with dementia
- English speaking
- literate - able to read course materials
- mentally intact with no history of mental illness
- reachable by phone
- able to attend weekly classes in the Bloomington area
- interested in either type of program (psycho-educational/mind-body intervention)
- willing to complete an informed consent process
- willing to be randomized and participate in one of two interventions
- experiencing significant stress (scale of 1-10 score of 5 or higher)
Exclusion Criteria:
- have previously participated in a community caregiver education and support group
- have previously completed formal training in other mind body practices such as
meditation, yoga, or tai chi, or who are currently practicing
- are regularly practicing mindfulness meditation
- express uncertainty that they can attend the intervention on a regular basis
- not experiencing significant stress
Age minimum:
21 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Caregivers
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Dementia
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Stress
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Intervention(s)
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Behavioral: Caregiver Education & Social Support
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Behavioral: Mindfulness-Based Stress Reduction
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Primary Outcome(s)
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Evaluate the feasibility of conducting a trial comparing mindfulness-based stress reduction (MBSR) and community caregiver education and support (CESS) programs on stress reduction for caregivers of patients with dementia.
[Time Frame: end of study]
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Secondary Outcome(s)
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Estimate the effectiveness of a MBSR program compared to a standard CESS program for caregivers of persons with dementia.
[Time Frame: end of study]
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Secondary ID(s)
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1 R21 AT003654-01A1
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R21AT003654-01A1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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