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Improving Well-Being for Older Adult Family Dementia Caregivers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03881631
Recruitment Status : Active, not recruiting
First Posted : March 19, 2019
Last Update Posted : November 7, 2022
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Kathi Heffner, University of Rochester

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stress, Psychological Behavioral: Mindfulness Based Stress Reduction Program Behavioral: Living Well Program Not Applicable

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 142 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Mindfulness-Based Stress Reduction for Family Caregivers of Dementia Patients
Actual Study Start Date : July 18, 2016
Estimated Primary Completion Date : April 28, 2023
Estimated Study Completion Date : April 28, 2023

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Mindfulness Based Stress Reduction (MBSR) Program
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.
Behavioral: Mindfulness Based Stress Reduction Program
Group-based intervention
Other Name: MBSR

Active Comparator: Living Well (LW) Program
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.
Behavioral: Living Well Program
Group-based intervention

No Intervention: Usual Care
The usual care arm is a no intervention group wherein participants experience their usual circumstances.

Primary Outcome Measures :
  1. Antibody response to influenza vaccination [ Time Frame: pre-vaccination to 6 weeks and 6 months post-vaccination ]
    Change in amount of antibody titers following influenza vaccination

Secondary Outcome Measures :
  1. Granzyme B (GrzB) activity after influenza vaccination [ Time Frame: pre-vaccination to 6 weeks and 6 months post-vaccination ]
    Change in GrzB activity, a measure of antigen-specific cytotoxic T cell activity, following influenza vaccination

  2. Ratio of T-cell cytokines, interferon (IFN)-gamma and IL-10 [ Time Frame: pre-vaccination to 6 weeks and 6 months post-vaccination ]
    Change in IFN:IL-10 ratio following influenza vaccination

  3. Inflammatory cytokines, interleukin (IL)-6 and tumor necrosis factor (TNF)-alpha [ Time Frame: baseline to 6 weeks to 6 months post-intervention ]
    Change in inflammatory cytokine levels over time

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 55 years of age and older
  • English-speaking (consent process and assessments will be conducted in English only)
  • Currently living with or in proximity to, and the primary caregiver for, a loved one with dementia who lives in the community-for the purposes of this study, "loved one" refers to a family member such as a spouse, ex-spouse, significant other, sibling, in-law, parent, or other type of close established relationship (e.g., close friend) regarded as family; "primary caregivers" provide daily informal (non-paid) in-person care.
  • Currently experiencing moderate to high levels of perceived stress (PSS-10 ≥ 12) and/or caregiver burden (MCSI ≥ 5)
  • Participants will be asked to stabilize medications prior to beginning the trial, and for the duration of the trial (If medication dose changes do occur, analytic models will include those changes as time-varying covariates)

Exclusion Criteria:

  • Loved one with dementia currently resides in a long-term care facility (e.g., nursing home) without the caregiver.
  • Given the didactic and self-directed nature of the MBSR program, individuals with major, uncorrected sensory impairments and cognitive deficits, as determined by a Montreal Cognitive Assessment (MoCA) score of 23 or lower 29, will be excluded, as will participants with other neuropsychological deficits deemed significant enough to interfere with study participation. Low literacy is not an exclusion criterion; questionnaires will be orally administered when necessary.
  • Modules from the Mini International Neuropsychiatric Exam (MINI 30) will be used to exclude subjects who have these psychiatric conditions: current alcohol dependence, current non-alcohol psychoactive substance use dependence, psychotic disorders (current and lifetime), bipolar disorder, and current mood disorder with psychotic features.
  • Subjects will also be excluded for the following reasons: having completed an MBSR program in the past; allergy to eggs (the influenza vaccine is most commonly manufactured using an egg-based process); history of Guillain-Barré syndrome; immunodeficiency or receipt of immunosuppressive therapy; recent major surgery; and active neoplastic disease.

Information from the National Library of Medicine

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): NCT03881631

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United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
National Institute on Aging (NIA)
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Principal Investigator: Kathi L Heffner, PhD University of Rochester
  Study Documents (Full-Text)

Documents provided by Kathi Heffner, University of Rochester:
Informed Consent Form  [PDF] July 27, 2022

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Responsible Party: Kathi Heffner, Associate Professor, University of Rochester
ClinicalTrials.gov Identifier: NCT03881631    
Other Study ID Numbers: STUDY00000881
R01AG052495 ( U.S. NIH Grant/Contract )
First Posted: March 19, 2019    Key Record Dates
Last Update Posted: November 7, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data sharing is in accordance with NIH Data Sharing Policy.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Within 12 months of study end

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stress, Psychological
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Behavioral Symptoms