Improving Well-Being for Older Adult Family Dementia Caregivers

NCT03881631 | Completed DMC

• 2 other identifiers: STUDY00000881R01AG052495
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress, Psychological

Outcome Measures

Primary Outcomes (1)

• Antibody response to influenza vaccination

  Change in amount of antibody titers following influenza vaccination

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

Secondary Outcomes (3)

• 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

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

  baseline to 6 weeks to 6 months post-intervention

Study Arms (3)

Mindfulness Based Stress Reduction (MBSR) Program

EXPERIMENTAL

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

Living Well (LW) Program

ACTIVE COMPARATOR

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

Usual Care

NO INTERVENTION

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

Interventions

Mindfulness Based Stress Reduction Program BEHAVIORAL

Group-based intervention

Also known as: MBSR

Mindfulness Based Stress Reduction (MBSR) Program

Living Well Program BEHAVIORAL

Group-based intervention

Living Well (LW) Program

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Loved one with dementia currently resides in a long-term care facility (e.g., nursing home) without the caregiver.
• 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.

Sponsors & Collaborators

• University of Rochester: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Kathi L Heffner, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 15, 2019
• First Posted: March 19, 2019
• Study Start: July 18, 2016
• Primary Completion: May 3, 2023
• Study Completion: May 3, 2023
• Last Updated: May 8, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Within 12 months of study end

Locations

US (1)