Stress, Psychologic
Conditions
Keywords
Mindfulness-Based Stress Reduction, MBSR, Seniors, immune system, keyhole limpet hemocyanin (KLH)
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: 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.
Interventions
BEHAVIORALMindfulness-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.
Sponsors
National Institute on Aging (NIA)
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| IgG Anti-KLH Antibody Response Post-treatment | 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 | 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 | 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. |
Countries
United States
Participant flow
Recruitment details
Between March 2006 and August 2009, women and men ages 65 and older were recruited from the community via advertisements in local newspapers and from University of Rochester Strong Health-associated primary care offices using flyers. Exclusion criteria were utilized as indicated in the protocol section.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 105 |
| Wait-list Control Wait-list control participants were offered MBSR training after completion of their primary assessments periods. | 103 |
| Total | 208 |
Baseline characteristics
| Characteristic | Total | Mindfulness-Based Stress Reduction | Wait-list Control |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 205 Participants | 103 Participants | 102 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants | 2 Participants | 1 Participants |
| Age, Continuous | 73.02 years STANDARD_DEVIATION 6.7 | 72.3 years STANDARD_DEVIATION 6.7 | 73.6 years STANDARD_DEVIATION 6.7 |
| Region of Enrollment United States | 208 participants | 105 participants | 103 participants |
| Sex: Female, Male Female | 129 Participants | 65 Participants | 64 Participants |
| Sex: Female, Male Male | 79 Participants | 40 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 105 | 0 / 103 |
| serious Total, serious adverse events | 0 / 105 | 0 / 103 |
Outcome results
Primary
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.
Time frame: post-treatment (time 2)
Population: Some subject EEG recordings were excluded from analyses due to reading/equipment factors (e.g., poor signal, external noise) or subject factors (e.g., sleepiness, illness). Subjects were also allowed to opt out of the EEG procedures if desired.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness-Based Stress Reduction | Electroencephalography Measurement | 0.067 Log right-log left alpha power | Standard Error 0.03 |
| Wait-list Control | Electroencephalography Measurement | -0.25 Log right-log left alpha power | Standard Error 0.03 |
p-value: 0.03ANOVA
Primary
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).
Time frame: Immediate post-treatment (time 2)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness-Based Stress Reduction | IgG Anti-KLH Antibody Response Post-treatment | 0.172 OD 405 nm | Standard Error 0.04 |
| Wait-list Control | IgG Anti-KLH Antibody Response Post-treatment | 0.104 OD 405 nm | Standard Error 0.032 |
p-value: 0.007GEE
Primary
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.
Time frame: immediate post-treatment (Time 2)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness-Based Stress Reduction | Trail Making Test | 1.75 Trails B:A score | Standard Error 0.1 |
| Wait-list Control | Trail Making Test | 2.01 Trails B:A score | Standard Error 0.11 |
p-value: 0.04GEE