Improving Well-Being for Older Adult Family Dementia Caregivers

• ClinicalTrials.gov Identifier: NCT03881631
• Recruitment Status: Active, not recruiting
• First Posted: March 19, 2019
• Last Update Posted: November 7, 2022
• Sponsor: University of Rochester
• Collaborator: National Institute on Aging (NIA)
• Information provided by (Responsible Party): Kathi Heffner, University of Rochester

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

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

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.

Contacts and Locations

Locations

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)

Investigators

• 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

More Information

• 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
• 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

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Dementia; Stress, Psychological; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Behavioral Symptoms