The Balance Study Balancing Life and Reducing Stress For Those Providing Elder Care
NCT ID: NCT00615082
Last Updated: 2023-09-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
78 participants
INTERVENTIONAL
2007-02-28
2011-03-31
Brief Summary
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Detailed Description
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Substudy The purpose of this proposal is to add a physiologic outcome sub-study to the Balance project that will examine four biological markers correlated with stress in caregivers participating in the study intervention. The Balance Study is a recently funded NIH randomized controlled pilot study to evaluate the acceptability and feasibility of a Mindfulness-Based Stress Reduction (MBSR) intervention for caregivers of patients with dementia. Balance is randomizing caregivers (N=60) into equal numbers to participate in either an intervention arm consisting of a MBSR program that includes eight weeks of group instruction in mindfulness meditation techniques followed by home practice or an active control arm consisting of a standard eight week community Caregiver Education and Social Support (CESS) program. The specific aims of this study are to: 1) evaluate the feasibility of adding physiologic markers to the Balance Study; 2) examine changes over time in individual study participants on four biological markers correlated with stress including interleukin 6 (IL-6), D-dimer, DHEA-S and telomere length; and 3) to examine preliminary differences between MBSR and CESS groups on four biological markers. The addition of physiologic outcomes to the Balance Study presents an emerging opportunity to increase the competitiveness for our NIH R01 application.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Mindfulness-Based Stress Reduction
Behavioral: Mindfulness-Based Stress Reduction
Other Names:
MBSR An 8-week course led by an experienced instructor in a group format of up to 15 people. Participants in the MBSR course learn mindfulness meditation techniques and simple yoga exercises such as stretching.
Mindfulness-Based Stress Reduction
An 8-week course led by an experienced instructor in a group format of up to 15 people. Participants in the MBSR course learn mindfulness meditation techniques and simple yoga exercises such as stretching.
Caregiver Education & Social Support
Behavioral: Caregiver Education \& Social Support
Other Names:
CESS An 8-week course led by experienced instructors in a group format of up to 15 people. Participants in the CESS course learn about a variety of important issues related to elder care and receive social and emotional support in a group discussion format.
Caregiver Education & Social Support
An 8-week course led by experienced instructors in a group format of up to 15 people. Participants in the CESS course learn about a variety of important issues related to elder care and receive social and emotional support in a group discussion format.
Interventions
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Mindfulness-Based Stress Reduction
An 8-week course led by an experienced instructor in a group format of up to 15 people. Participants in the MBSR course learn mindfulness meditation techniques and simple yoga exercises such as stretching.
Caregiver Education & Social Support
An 8-week course led by experienced instructors in a group format of up to 15 people. Participants in the CESS course learn about a variety of important issues related to elder care and receive social and emotional support in a group discussion format.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
21 Years
ALL
Yes
Sponsors
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National Center for Complementary and Integrative Health (NCCIH)
NIH
HealthPartners Institute
OTHER
Responsible Party
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Principal Investigators
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Robin Whitebird, PhD
Role: PRINCIPAL_INVESTIGATOR
HealthPartners Institute
Locations
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HealthPartners Research Foundation
Bloomington, Minnesota, United States
Countries
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Other Identifiers
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