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Improving Well-Being for Older Adult Family Dementia Caregivers

Primary Purpose

Stress, Psychological

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Mindfulness Based Stress Reduction Program

Living Well Program

About this trial

This is an interventional prevention trial for Stress, Psychological

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

University of Rochester Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

No Intervention

Arm Label

Mindfulness Based Stress Reduction (MBSR) Program

Living Well (LW) Program

Usual Care

Arm Description

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.

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.

The usual care arm is a no intervention group wherein participants experience their usual circumstances.

Outcomes

Primary Outcome Measures

Antibody response to influenza vaccination

Change in amount of antibody titers following influenza vaccination

Secondary Outcome Measures

Granzyme B (GrzB) activity after influenza vaccination

Change in GrzB activity, a measure of antigen-specific cytotoxic T cell activity, following influenza vaccination

Ratio of T-cell cytokines, interferon (IFN)-gamma and IL-10

Change in IFN:IL-10 ratio following influenza vaccination

Inflammatory cytokines, interleukin (IL)-6 and tumor necrosis factor (TNF)-alpha

Change in inflammatory cytokine levels over time

Full Information

NCT ID

NCT03881631

First Posted

March 15, 2019

Last Updated

May 5, 2023

Sponsor

University of Rochester

Collaborators

National Institute on Aging (NIA)

1. Study Identification

Unique Protocol Identification Number

NCT03881631

Brief Title

Improving Well-Being for Older Adult Family Dementia Caregivers

Official Title

Mindfulness-Based Stress Reduction for Family Caregivers of Dementia Patients

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Completed

Study Start Date

July 18, 2016 (Actual)

Primary Completion Date

May 3, 2023 (Actual)

Study Completion Date

May 3, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Rochester

Collaborators

National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stress, Psychological

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

142 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mindfulness Based Stress Reduction (MBSR) Program

Arm Type

Experimental

Arm Description

Arm Title

Living Well (LW) Program

Arm Type

Active Comparator

Arm Description

Arm Title

Usual Care

Arm Type

No Intervention

Arm Description

The usual care arm is a no intervention group wherein participants experience their usual circumstances.

Intervention Type

Behavioral

Intervention Name(s)

Mindfulness Based Stress Reduction Program

Other Intervention Name(s)

MBSR

Intervention Description

Group-based intervention

Intervention Type

Behavioral

Intervention Name(s)

Living Well Program

Intervention Description

Group-based intervention

Primary Outcome Measure Information:

Title

Antibody response to influenza vaccination

Description

Change in amount of antibody titers following influenza vaccination

Time Frame

pre-vaccination to 6 weeks and 6 months post-vaccination

Secondary Outcome Measure Information:

Title

Granzyme B (GrzB) activity after influenza vaccination

Description

Change in GrzB activity, a measure of antigen-specific cytotoxic T cell activity, following influenza vaccination

Time Frame

pre-vaccination to 6 weeks and 6 months post-vaccination

Title

Ratio of T-cell cytokines, interferon (IFN)-gamma and IL-10

Description

Change in IFN:IL-10 ratio following influenza vaccination

Time Frame

pre-vaccination to 6 weeks and 6 months post-vaccination

Title

Inflammatory cytokines, interleukin (IL)-6 and tumor necrosis factor (TNF)-alpha

Description

Change in inflammatory cytokine levels over time

Time Frame

baseline to 6 weeks to 6 months post-intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kathi L Heffner, PhD

Organizational Affiliation

University of Rochester

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Rochester Medical Center

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Data sharing is in accordance with NIH Data Sharing Policy.

IPD Sharing Time Frame

Within 12 months of study end

Learn more about this trial

Improving Well-Being for Older Adult Family Dementia Caregivers

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