Improving Well-Being for Older Adult Family Dementia Caregivers



Status:Recruiting
Conditions:Neurology, Psychiatric
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:55 - Any
Updated:3/21/2019
Start Date:July 18, 2016
End Date:April 2021
Contact:Jeff Swan
Email:mindbody@urmc.rochester.edu
Phone:(585) 275-6835

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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.

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.
We found this trial at
1
site
601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Rochester, NY
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