Mindfulness to Improve Elders' Immune and Health Status
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Rochester
- Enrollment
- 208
- Locations
- 2
- Primary Endpoint
- IgG Anti-KLH Antibody Response Post-treatment
Study Overview
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:
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
IgG Anti-KLH Antibody Response Post-treatment
Time Frame: Immediate post-treatment (time 2)
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).
Trail Making Test
Time Frame: immediate post-treatment (Time 2)
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.
Electroencephalography Measurement
Time Frame: post-treatment (time 2)
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Jan Moynihan
Director, The Rochester Center for Mind-Body Research, University of Rochester Medical Center
University of Rochester