Trial Outcomes & Findings for Mindfulness to Improve Elders' Immune and Health Status (NCT NCT01027780)
NCT ID: NCT01027780
Last Updated: 2014-08-27
Results Overview
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).
COMPLETED
NA
208 participants
Immediate post-treatment (time 2)
2014-08-27
Participant Flow
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.
Participant milestones
| Measure |
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.
|
Wait-list Control
Wait-list control participants were offered MBSR training after completion of their primary assessments periods.
|
|---|---|---|
|
Overall Study
STARTED
|
105
|
103
|
|
Overall Study
COMPLETED
|
105
|
102
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mindfulness to Improve Elders' Immune and Health Status
Baseline characteristics by cohort
| Measure |
Mindfulness-Based Stress Reduction
n=105 Participants
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
n=103 Participants
Wait-list control participants were offered MBSR training after completion of their primary assessments periods.
|
Total
n=208 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
103 Participants
n=5 Participants
|
102 Participants
n=7 Participants
|
205 Participants
n=5 Participants
|
|
Age, Continuous
|
72.3 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
73.6 years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
73.02 years
STANDARD_DEVIATION 6.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
65 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
105 participants
n=5 Participants
|
103 participants
n=7 Participants
|
208 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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).
Outcome measures
| Measure |
Mindfulness-Based Stress Reduction
n=105 Participants
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
n=103 Participants
Wait-list control participants were offered MBSR training after completion of their primary assessments periods.
|
|---|---|---|
|
IgG Anti-KLH Antibody Response Post-treatment
|
0.172 OD 405 nm
Standard Error .04
|
0.104 OD 405 nm
Standard Error .032
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Mindfulness-Based Stress Reduction
n=105 Participants
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
n=103 Participants
Wait-list control participants were offered MBSR training after completion of their primary assessments periods.
|
|---|---|---|
|
Trail Making Test
|
1.75 Trails B:A score
Standard Error .1
|
2.01 Trails B:A score
Standard Error .11
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Mindfulness-Based Stress Reduction
n=55 Participants
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
n=55 Participants
Wait-list control participants were offered MBSR training after completion of their primary assessments periods.
|
|---|---|---|
|
Electroencephalography Measurement
|
0.067 Log right-log left alpha power
Standard Error .03
|
-0.25 Log right-log left alpha power
Standard Error .03
|
Adverse Events
Mindfulness-Based Stress Reduction
Wait-list Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place