Mindfulness to Improve Elders' Immune and Health Status

Study Overview
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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: 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.

Official Title
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Mindfulness to Improve Elders' Immune and Health Status

Conditions
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Stress, Psychologic

Intervention / Treatment
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* Behavioral: Mindfulness-Based Stress Reduction


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mindfulness-Based Stress Reduction<br>Participation in the Mindfulness-Based Stress Reduction (MBSR) program following the initial assessment period, just prior to the start of the immunological measures. | Behavioral: Mindfulness-Based Stress Reduction<br>* 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.<br>* Other names: MBSR;|
| No Intervention: Wait-list control<br>Wait-list control participants were offered MBSR training after completion of their primary assessments periods. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IgG Anti-KLH Antibody Response Post-treatment | Immune function--specifically, antibody response to a novel, benign antigen (an antigen to which subjects are immunologically naïve); in this case, keyhole limpet hemocyanin (KLH). | Immediate post-treatment (time 2) | 
| Trail Making Test | The Trail Making Test is a commonly used neuropsychological test of visual attention and task-switching. In two timed tasks, subjects are asked to first connect numbers (Test A), then alternating numbers and letters (Test B), in sequential order as quickly as possible. Completion times, relating to cognitive processing speed and executive function (respectively), may be utilized individually, and as a difference (B-A) or ratio (B/A) score. The Trails B/A ratio was used as an index of improvement in executive control throughout the trial, with lower scores indicating better performance. | immediate post-treatment (Time 2) | 
| Electroencephalography Measurement | Measurement of alpha asymmetry at the F3/4 (frontal) electrode. Left prefrontal activation has been associated with positive affect, and with higher levels of antibody responses and natural killer cell cytotoxicity. | post-treatment (time 2) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MBSR, Mindfulness-Based Stress Reduction, Seniors, immune system, keyhole limpet hemocyanin (KLH)