Improving Well-Being for Older Adult Family Dementia Caregivers
NCT ID: NCT03881631
Last Updated: 2023-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
142 participants
INTERVENTIONAL
2016-07-18
2023-05-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
PREVENTION
SINGLE
Study Groups
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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.
Mindfulness Based Stress Reduction Program
Group-based intervention
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.
Living Well Program
Group-based intervention
Usual Care
The usual care arm is a no intervention group wherein participants experience their usual circumstances.
No interventions assigned to this group
Interventions
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Mindfulness Based Stress Reduction Program
Group-based intervention
Living Well Program
Group-based intervention
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
55 Years
ALL
Yes
Sponsors
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National Institute on Aging (NIA)
NIH
University of Rochester
OTHER
Responsible Party
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Kathi Heffner
Associate Professor
Principal Investigators
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Kathi L Heffner, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester
Locations
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University of Rochester Medical Center
Rochester, New York, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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STUDY00000881
Identifier Type: -
Identifier Source: org_study_id
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