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OpenTrials
Completed

NCT Number: NCT03881631

Improving Well-Being for Older Adult Family Dementia Caregivers

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.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Rochester Medical Center

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness based stress reduction program

Behavioral

Group-based intervention

Other names: MBSR

Living Well Program

Behavioral

Group-based intervention

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Mindfulness-Based Stress Reduction for Family Caregivers of Dementia Patients

Important dates

Study start
2016
Primary completion
2023
Study completion
2023
First posted
Mar 19, 2019
Registry last updated
May 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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