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| ID | Type | Description | Link |
|---|---|---|---|
| R01AG052495 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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This study will examine the effects of the Mindfulness-Based Stress Reduction (MBSR) program and the Living Well program, compared to a control group, to see if the programs might be associated with better immune function (response to current influenza vaccine), physical and emotional health, and well-being.
A considerable literature documents that a wide variety of psychosocial interventions can lessen the psychological burden of family or spousal dementia caregiving. Some caregiver intervention studies have included measures of self-reported physical health and sleep, and others have focused on improving inflammation in caregivers. The current study will add to this literature by examining the effects of two behavioral interventions on adaptive immune responses, particularly, antibody response to influenza vaccination, in older adult family caregivers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness Based Stress Reduction (MBSR) Program | Experimental | The MBSR program is an eight-week-long course designed to teach subjects how to develop their inner resources in the service of taking better care of themselves. MBSR training includes the learning and refining of a range of skills aimed at increasing relaxation and awareness of physical experiences and sensations related to physical symptoms, emotions, and thoughts. Special emphasis is placed on movement, meditation, and breathing. |
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| Living Well (LW) Program | Active Comparator | LW is an eight-week course of group presentations and discussions on topics related to the promotion of health and well-being in the context of dementia caregiving. LW is designed to teach participants how to improve their physical and emotional health as a complement to traditional medical treatments. |
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| Usual Care | No Intervention | The usual care arm is a no intervention group wherein participants experience their usual circumstances. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Based Stress Reduction Program | Behavioral | Group-based intervention |
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| Measure | Description | Time Frame |
|---|---|---|
| Antibody response to influenza vaccination | Change in amount of antibody titers following influenza vaccination | pre-vaccination to 6 weeks and 6 months post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Granzyme B (GrzB) activity after influenza vaccination | Change in GrzB activity, a measure of antigen-specific cytotoxic T cell activity, following influenza vaccination | pre-vaccination to 6 weeks and 6 months post-vaccination |
| Ratio of T-cell cytokines, interferon (IFN)-gamma and IL-10 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathi L Heffner, PhD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
Data sharing is in accordance with NIH Data Sharing Policy.
Within 12 months of study end
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Jul 27, 2022 | Sep 6, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Living Well Program | Behavioral | Group-based intervention |
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Change in IFN:IL-10 ratio following influenza vaccination |
| pre-vaccination to 6 weeks and 6 months post-vaccination |
| Inflammatory cytokines, interleukin (IL)-6 and tumor necrosis factor (TNF)-alpha | Change in inflammatory cytokine levels over time | baseline to 6 weeks to 6 months post-intervention |