An interventional study of Mindfulness-Based Stress Reduction and Caregiver Education & Social Support in Dementia, Caregivers and Stress, sponsored by HealthPartners Institute. Completed at 1 site in United States. Open to participants aged 21 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-07.
Sponsored by HealthPartners Institute · Not applicable, Interventional, and Supportive care
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.
2,172 studies on the registry are indexed under Dementia; 540 are open to participants now.
This study's enrollment of 78 is close to the median of 83 across 1,629 interventional studies indexed under Dementia.
Browse Dementia studies →HealthPartners Institute is the lead sponsor of 164 studies on the registry; 20 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 16 (94%) have results posted.
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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.
Behavioral: Mindfulness-Based Stress Reduction
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.
Behavioral: Caregiver Education & Social Support
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.
Also known as: MBSR
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.
Also known as: 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.
participants will complete surveys and consent to a blood draw at baseline, post intervention, and 6 months. They will complete a daily health behaviors calendar, and a subset will track their daily blood pressure.
Time frame: through study completion, an average of 1 year
Estimate the effectiveness of a MBSR program compared to a standard CESS program for caregivers of persons with dementia.
participants will complete surveys and consent to a blood draw at baseline, post intervention, and 6 months. They will complete a daily health behaviors calendar, and a subset will track their daily blood pressure.
Time frame: through study completion, an average of 1 year
This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
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