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The Balance Study Balancing Life and Reducing Stress For Those Providing Elder Care (Balance)

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ClinicalTrials.gov Identifier: NCT00615082
Recruitment Status : Completed
First Posted : February 14, 2008
Last Update Posted : September 8, 2011
Sponsor:
Collaborator:
National Center for Complementary and Integrative Health (NCCIH)
Information provided by (Responsible Party):
HealthPartners Institute

Study Description
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Brief Summary:

The primary goals of this exploratory/developmental (R21) study are to evaluate the feasibility and acceptability of a MBSR intervention for caregivers of patients with dementia, and to estimate the effectiveness of program outcomes on standardized measures of perceived stress, psychological distress and caregiver burden. We will randomize 60 caregivers 1:1 to participate in: 1.) an intervention arm consisting of a MBSR program that includes 8 weeks of group instruction in mindfulness meditation techniques followed by home practice, or 2.) an active control arm consisting of a standard 8 week Community Caregiver Education and Support (CESS) program.

We anticipate that caregivers will be interested in participating in the intervention, be open to randomization, and have good rates of compliance with the program. It is also expected that MBSR program participants will evidence a trend toward better outcomes than CESS participants on primary outcome measures of perceived stress, psychological distress and perceived caregiver burden.

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.


Condition or disease Intervention/treatment Phase
Dementia Caregivers Stress Behavioral: Mindfulness-Based Stress Reduction Behavioral: Caregiver Education & Social Support Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Stress Reduction for Caregivers: A Randomized Controlled Pilot Study
Study Start Date : February 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caregivers Dementia

Arms and Interventions
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Arm Intervention/treatment
Experimental: Mindfulness-Based Stress Reduction Behavioral: 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.
Other Name: MBSR
Active Comparator: Caregiver Education & Social Support Behavioral: 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 Name: CESS


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Estimate the effectiveness of a MBSR program compared to a standard CESS program for caregivers of persons with dementia. [ Time Frame: end of study ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00615082


Locations
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United States, Minnesota
HealthPartners Research Foundation
Bloomington, Minnesota, United States, 55425
Sponsors and Collaborators
HealthPartners Institute
National Center for Complementary and Integrative Health (NCCIH)
Investigators
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Principal Investigator: Robin Whitebird, PhD HealthPartners Institute
More Information
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Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT00615082    
Other Study ID Numbers: 1R21AT003654-01A1 ( U.S. NIH Grant/Contract )
R21AT003654-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 14, 2008    Key Record Dates
Last Update Posted: September 8, 2011
Last Verified: September 2011
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Neurocognitive Disorders
Mental Disorders