Mindfulness to Improve Elders' Immune and Health Status

NCT ID: NCT01027780

Last Updated: 2014-08-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

208 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2009-08-31

Brief Summary

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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

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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.

Conditions

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Stress, Psychologic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Mindfulness-Based Stress Reduction

Participation in the Mindfulness-Based Stress Reduction (MBSR) program following the initial assessment period, just prior to the start of the immunological measures.

Group Type ACTIVE_COMPARATOR

Mindfulness-Based Stress Reduction

Intervention Type BEHAVIORAL

The standardized Mindfulness-Based Stress Reduction (MBSR) program is the primary training tool used to enhance mindfulness. The eight-week-long MBSR program is 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.

Wait-list control

Wait-list control participants were offered MBSR training after completion of their primary assessments periods.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mindfulness-Based Stress Reduction

The standardized Mindfulness-Based Stress Reduction (MBSR) program is the primary training tool used to enhance mindfulness. The eight-week-long MBSR program is 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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MBSR

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Jan Moynihan

Director, The Rochester Center for Mind-Body Research, University of Rochester Medical Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jan A Moynihan, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

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University of Rochester Medical Center

Rochester, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 23697871 (View on PubMed)

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.

Reference Type RESULT
PMID: 23383976 (View on PubMed)

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.

Reference Type RESULT
PMID: 23774986 (View on PubMed)

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.

Reference Type RESULT
PMID: 21241793 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27511921 (View on PubMed)

Other Identifiers

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R01AG025474

Identifier Type: NIH

Identifier Source: secondary_id

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1R01AG025474

Identifier Type: NIH

Identifier Source: org_study_id

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