Mindfulness-Based Stress Reduction for Family Caregivers of Dementia Patients
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Stress, Psychological
- Sponsor
- University of Rochester
- Enrollment
- 142
- Locations
- 1
- Primary Endpoint
- Antibody response to influenza vaccination
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
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.
Investigators
Kathi Heffner
Associate Professor
University of Rochester
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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 Outcomes
- Inflammatory cytokines, interleukin (IL)-6 and tumor necrosis factor (TNF)-alpha(baseline to 6 weeks to 6 months post-intervention)
- Granzyme B (GrzB) activity after influenza vaccination(pre-vaccination to 6 weeks and 6 months post-vaccination)
- Ratio of T-cell cytokines, interferon (IFN)-gamma and IL-10(pre-vaccination to 6 weeks and 6 months post-vaccination)