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The Balance Study Balancing Life and Reducing Stress For Those Providing Elder Care
This study is currently recruiting participants.
Verified by HealthPartners Research Foundation, February 2009
First Received: February 1, 2008   Last Updated: February 24, 2009   History of Changes
Sponsors and Collaborators: HealthPartners Research Foundation
National Center for Complementary and Alternative Medicine (NCCAM)
Information provided by: HealthPartners Research Foundation
ClinicalTrials.gov Identifier: NCT00615082
  Purpose

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 (CCES) 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 CCES 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 Intervention
Dementia
Caregivers
Stress
Behavioral: Mindfulness Based Stress Reduction
Behavioral: Caregiver Education and Social Support

MedlinePlus related topics: Caregivers Dementia
U.S. FDA Resources
Study Type: Interventional
Study Design: Supportive Care, Randomized, Double Blind (Investigator, Outcomes Assessor), Parallel Assignment
Official Title: Stress Reduction for Caregivers: A Randomized Controlled Pilot Study

Further study details as provided by HealthPartners Research Foundation:

Primary Outcome Measures:
  • Evaluate the feasibility of conducting a trial comparing mindfulness-based stress reduction (MBSR) and community caregiver education and support (CCES) programs on stress reduction for caregivers of patients with dementia. [ Time Frame: end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Estimate the effectiveness of a MBSR program compared to a standard CCES program for caregivers of persons with dementia. [ Time Frame: end of study ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2007
Estimated Study Completion Date: November 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
MBSR: Active Comparator 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.
CESS: Active Comparator Behavioral: Caregiver Education and 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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00615082

Contacts
Contact: Chris Enstad, BS 952-967-5007 Chris.Enstad@HealthPartners.com

Locations
United States, Minnesota
HealthPartners Research Foundation Recruiting
Bloomington, Minnesota, United States, 55425
Contact: Chris Enstad     952-967-5007     Chris.Enstad@HealthPartners.com    
Principal Investigator: Robin Whitebird, PhD            
Sponsors and Collaborators
HealthPartners Research Foundation
Investigators
Principal Investigator: Robin Whitebird, PhD HealthPartners Research Foundation
  More Information

No publications provided

Responsible Party: HealthPartners Research Foundation ( Robin Whitebird Principal Investigator )
Study ID Numbers: 1 R21 AT003654-01A1, #06-072
Study First Received: February 1, 2008
Last Updated: February 24, 2009
ClinicalTrials.gov Identifier: NCT00615082     History of Changes
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Central Nervous System Diseases
Stress
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:
Delirium, Dementia, Amnestic, Cognitive Disorders
Pathologic Processes
Mental Disorders
Nervous System Diseases
Central Nervous System Diseases
Stress
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on May 07, 2009