Mindfulness to Improve Elders' Immune and Health Status

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University of Rochester

Status

Completed

Conditions

Stress, Psychologic

Treatments

Behavioral: Mindfulness-Based Stress Reduction

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT01027780
1R01AG025474
R01AG025474 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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: 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. To examine whether treatment effects are moderated by age, personality traits, physical health status, or depression. To examine the effects of behavioral, psychological, and physiological mediators of immune outcome.

Enrollment

208 patients

Sex

All

Ages

65+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

208 participants in 2 patient groups

Mindfulness-Based Stress Reduction
Active Comparator group
Description:
Participation in the Mindfulness-Based Stress Reduction (MBSR) program following the initial assessment period, just prior to the start of the immunological measures.
Treatment:
Behavioral: Mindfulness-Based Stress Reduction
Wait-list control
No Intervention group
Description:
Wait-list control participants were offered MBSR training after completion of their primary assessments periods.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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