Stress, PsychologicNCT01027780

Mindfulness to Improve Elders' Immune and Health Status

A study testing Mindfulness-Based Stress Reduction in people with Stress, Psychologic, run by University of Rochester at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for: Stress, Psychologic
What is being tested?: Mindfulness-Based Stress Reduction
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 208 participants
Where: 1 siteUnited States
Study dates: Mar 2006to Aug 2009
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 65 years and older
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

Age 65 or older
English speaking
If prescribed antidepressant or anxiolytic medications, must have maintained a stable regimen for eight weeks prior to enrolling

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Rochester Medical Center
Rochester, New York, 14642

Other trials in United States

About this study

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.

Read the 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.

Conditions: Stress, Psychologic
Being tested: Mindfulness-Based Stress Reduction
Keywords: Mindfulness-Based Stress Reduction, MBSR, Seniors, immune system, keyhole limpet hemocyanin (KLH)
Medical subject headings: Stress, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mindfulness-Based Stress ReductionBehavioural
Also called MBSR
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.

Study groups in NCT01027780
Study group	Role	What they receive
Mindfulness-Based Stress Reduction	Active comparator	Participation in the Mindfulness-Based Stress Reduction (MBSR) program following the initial assessment period, just prior to the start of the immunological measures. Receives: Behavioral: Mindfulness-Based Stress Reduction
Wait-list control	No intervention	Wait-list control participants were offered MBSR training after completion of their primary assessments periods.

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: 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.
Measured: 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.
Measured: post-treatment (time 2)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2006Aug 2009

First posted9 Dec 2009 (estimated)
Study startMar 2006
Primary completionMay 2009
Study completionAug 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (5)Papers the sponsor has linked to this study.
Other trials for Stress, PsychologicStudies of the same condition, open and under way.
More trials run by University of RochesterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 208 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01027780
Sponsor's protocol ID: 1R01AG025474
Other IDs: R01AG025474
Status last verified: Jan 2014
First submitted: 6 Dec 2009
Last updated: 27 Aug 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 23697871
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.
PubMed 23383976
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.
PubMed 23774986
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.
PubMed 21241793
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.
PubMed 27511921

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mindfulness to Improve Elders' Immune and Health Status
ClinicalTrials.gov ID: NCT01027780
Acronym / sponsor ID: 1R01AG025474
Conditions: Stress, Psychologic
Keywords: Mindfulness-Based Stress Reduction, MBSR, Seniors, immune system, keyhole limpet hemocyanin (KLH)
Study type: Interventional
Recruitment status: Completed
Enrolment: 208 participants (actual)
Lead sponsor: University of RochesterUniversity, hospital or other
Collaborators: National Institute on Aging (NIA)
Study start: Mar 2006
Primary completion: May 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 9 Dec 2009 (estimated)
Results: Posted 27 Aug 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

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

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Mindfulness-Based Stress Reduction	Active comparator	Behavioral: Mindfulness-Based Stress ReductionParticipation 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	No intervention	–Wait-list control participants were offered MBSR training after completion of their primary assessments periods.

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (3 listed)

Age 65 or older
English speaking
If prescribed antidepressant or anxiolytic medications, must have maintained a stable regimen for eight weeks prior to enrolling

Key exclusion criteria (7 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mindfulness-Based Stress ReductionAlso: MBSRThe 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.	Behavioural	Mindfulness-Based Stress Reduction

Primary outcome

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.

Results and safety

Results posted to the registry on 27 Aug 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mindfulness-Based Stress Reduction	105	105
Wait-list Control	103	102

Primary outcome: IgG Anti-KLH Antibody Response Post-treatment

Time frame: Immediate post-treatment (time 2). Mean (Standard Error). Unit: OD 405 nm

Measure	Mindfulness-Based Stress Reduction n = 105	Wait-list Control n = 103
Value	0.172 (.04)	0.104 (.032)

Mindfulness-Based Stress Reduction vs Wait-list Control: p = .007, GEE

Primary outcome: Trail Making Test

Time frame: immediate post-treatment (Time 2). Mean (Standard Error). Unit: Trails B:A score

Measure	Mindfulness-Based Stress Reduction n = 105	Wait-list Control n = 103
Value	1.75 (.1)	2.01 (.11)

Mindfulness-Based Stress Reduction vs Wait-list Control: p = .04, GEE

Primary outcome: Electroencephalography Measurement

Time frame: post-treatment (time 2). Mean (Standard Error). Unit: Log right-log left alpha power

Measure	Mindfulness Based Stress Reduction n = 55	Wait-list Control n = 55
Value	0.067 (.03)	-0.25 (.03)

Mindfulness Based Stress Reduction vs Wait-list Control: p = .03, ANOVA

Population analysed: 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.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mindfulness-Based Stress Reduction	0 of 105 (0%)	0 of 105 (0%)	Not reported
Wait-list Control	0 of 103 (0%)	0 of 103 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23697871Gallegos 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 publication: PubMed 23383976Gallegos 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 publication: PubMed 23774986Moynihan 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 publication: PubMed 21241793Chapman 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.
Derived from this study: PubMed 27511921Gallegos 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jan A Moynihan, Ph.D principal investigator

University of Rochester

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness-Based Stress Reduction in people with Stress, Psychologic, run by University of Rochester at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Aug 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

IgG Anti-KLH Antibody Response Post-treatment (time frame: Immediate post-treatment (time 2)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01027780, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2014.