Mindfulness to Improve Elders' Immune and Health Status
Primary Purpose
Stress, Psychologic
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-Based Stress Reduction
Sponsored by
About this trial
This is an interventional treatment trial for Stress, Psychologic focused on measuring Mindfulness-Based Stress Reduction, MBSR, Seniors, immune system, keyhole limpet hemocyanin (KLH)
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
Sites / Locations
- University of Rochester Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Mindfulness-Based Stress Reduction
Wait-list control
Arm Description
Participation in the Mindfulness-Based Stress Reduction (MBSR) program following the initial assessment period, just prior to the start of the immunological measures.
Wait-list control participants were offered MBSR training after completion of their primary assessments periods.
Outcomes
Primary Outcome Measures
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).
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01027780
First Posted
December 6, 2009
Last Updated
August 12, 2014
Sponsor
University of Rochester
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT01027780
Brief Title
Mindfulness to Improve Elders' Immune and Health Status
Official Title
Mindfulness to Improve Elders' Immune and Health Status
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
August 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Institute on Aging (NIA)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychologic
Keywords
Mindfulness-Based Stress Reduction, MBSR, Seniors, immune system, keyhole limpet hemocyanin (KLH)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
208 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness-Based Stress Reduction
Arm Type
Active Comparator
Arm Description
Participation in the Mindfulness-Based Stress Reduction (MBSR) program following the initial assessment period, just prior to the start of the immunological measures.
Arm Title
Wait-list control
Arm Type
No Intervention
Arm Description
Wait-list control participants were offered MBSR training after completion of their primary assessments periods.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Stress Reduction
Other Intervention Name(s)
MBSR
Intervention Description
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.
Primary Outcome Measure Information:
Title
IgG Anti-KLH Antibody Response Post-treatment
Description
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).
Time Frame
Immediate post-treatment (time 2)
Title
Trail Making Test
Description
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.
Time Frame
immediate post-treatment (Time 2)
Title
Electroencephalography Measurement
Description
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.
Time Frame
post-treatment (time 2)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan A Moynihan, Ph.D
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
23697871
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.
Results Reference
result
PubMed Identifier
23383976
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.
Results Reference
result
PubMed Identifier
23774986
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.
Results Reference
result
PubMed Identifier
21241793
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.
Results Reference
result
PubMed Identifier
27511921
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.
Results Reference
derived
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Mindfulness to Improve Elders' Immune and Health Status
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