Clinical trial NCT01027780: Mindfulness to Improve Elders' Immune and Health Status
Official title: Mindfulness to Improve Elders' Immune and Health Status
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress, Psychologic
Keywords: Mindfulness-Based Stress Reduction
MBSR
Seniors
immune system
keyhole limpet hemocyanin (KLH)
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2009-12-09
Enrollment: 208
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to better understand effects of the Mindfulness-Based Stress-Reduction (MBSR) program on the physical and emotional health and well-being of adults ages 65 and older.

The effects MBSR may have on the immune system is investigated, including how these effects relate to factors such as perceived health, psychological well-being, age, personality, and mood.

Detailed description: This study investigates the effects of Mindfulness-Based Stress Reduction (MBSR) on immune responses to multiple concentrations of keyhole limpet hemocyanin (KLH) in elderly volunteers. The research design thus capitalizes on the antibody response to a novel, benign antigen to which our subjects will be immunologically naïve. The use of a range of antigen concentrations will provide a sensitive indicator for the effects of intervention.

The Aims of the study are the following:

1. To examine the effects of Mindfulness Based Stress Reduction (MBSR) on immunological outcomes, perceived health, and psychological well-being in a sample of seniors 65 years of age and older.
2. To examine whether treatment effects are moderated by age, personality traits, physical health status, or depression.
3. To examine the effects of behavioral, psychological, and physiological mediators of immune outcome.

Eligibility criteria: Inclusion Criteria:

* Age 65 or older
* English speaking
* If prescribed antidepressant or anxiolytic medications, must have maintained a stable regimen for eight weeks prior to enrolling

Exclusion Criteria:

* receiving immunosuppressive therapy for cancer or other diseases
* major, uncorrected sensory impairments
* cognitive deficits (MMSE \<25, or deficits deemed significant enough to interfere)
* history of a psychotic disorder, bipolar disorder, organic brain syndrome, or mental retardation
* alcohol or substance abuse within the previous year
* severe cardiovascular disease
* known allergies to shellfish

Primary outcomes:
measure: IgG Anti-KLH Antibody Response Post-treatment
timeFrame: Immediate post-treatment (time 2)
measure: Trail Making Test
timeFrame: immediate post-treatment (Time 2)
measure: Electroencephalography Measurement
timeFrame: post-treatment (time 2)
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: Jan A Moynihan, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gallegos AM, Hoerger M, Talbot NL, Moynihan JA, Duberstein PR. Emotional benefits of mindfulness-based stress reduction in older adults: the moderating roles of age and depressive symptom severity. Aging Ment Health. 2013;17(7):823-9. doi: 10.1080/13607863.2013.799118. Epub 2013 May 22.
citation: Gallegos AM, Hoerger M, Talbot NL, Krasner MS, Knight JM, Moynihan JA, Duberstein PR. Toward identifying the effects of the specific components of Mindfulness-Based Stress Reduction on biologic and emotional outcomes among older adults. J Altern Complement Med. 2013 Oct;19(10):787-92. doi: 10.1089/acm.2012.0028. Epub 2013 Feb 5.
citation: Moynihan JA, Chapman BP, Klorman R, Krasner MS, Duberstein PR, Brown KW, Talbot NL. Mindfulness-based stress reduction for older adults: effects on executive function, frontal alpha asymmetry and immune function. Neuropsychobiology. 2013;68(1):34-43. doi: 10.1159/000350949. Epub 2013 Jun 15.
citation: Chapman BP, van Wijngaarden E, Seplaki CL, Talbot N, Duberstein P, Moynihan J. Openness and conscientiousness predict 34-week patterns of Interleukin-6 in older persons. Brain Behav Immun. 2011 May;25(4):667-73. doi: 10.1016/j.bbi.2011.01.003. Epub 2011 Jan 15.
citation: Gallegos AM, Moynihan J, Pigeon WR. A Secondary Analysis of Sleep Quality Changes in Older Adults From a Randomized Trial of an MBSR Program. J Appl Gerontol. 2018 Nov;37(11):1327-1343. doi: 10.1177/0733464816663553. Epub 2016 Aug 10.