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
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||78 participants|
|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|
|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
- 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 ]
- Estimate the effectiveness of a MBSR program compared to a standard CESS program for caregivers of persons with dementia. [ Time Frame: end of study ]
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
|United States, Minnesota|
|HealthPartners Research Foundation|
|Bloomington, Minnesota, United States, 55425|
|Principal Investigator:||Robin Whitebird, PhD||HealthPartners Institute|