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Sponsors and Collaborators: |
HealthPartners Research Foundation National Center for Complementary and Alternative Medicine (NCCAM) |
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Information provided by: | HealthPartners Research Foundation |
ClinicalTrials.gov Identifier: | NCT00615082 |
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 |
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Dementia Caregivers Stress |
Behavioral: Mindfulness Based Stress Reduction Behavioral: Caregiver Education and Social Support |
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 |
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 |
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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.
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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.
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Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Chris Enstad, BS | 952-967-5007 | Chris.Enstad@HealthPartners.com |
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 |
Principal Investigator: | Robin Whitebird, PhD | HealthPartners Research Foundation |
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 |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Central Nervous System Diseases Stress |
Brain Diseases Dementia Cognition Disorders Delirium |
Delirium, Dementia, Amnestic, Cognitive Disorders Pathologic Processes Mental Disorders Nervous System Diseases |
Central Nervous System Diseases Stress Brain Diseases Dementia |