NCT01027780

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
208

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 6, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 9, 2009

Completed
4.7 years until next milestone

Results Posted

Study results publicly available

August 27, 2014

Completed
Last Updated

August 27, 2014

Status Verified

January 1, 2014

Enrollment Period

3.2 years

First QC Date

December 6, 2009

Results QC Date

June 14, 2012

Last Update Submit

August 12, 2014

Conditions

Stress, Psychologic

Keywords

Mindfulness-Based Stress ReductionMBSRSeniorsimmune systemkeyhole limpet hemocyanin (KLH)

Outcome Measures

Primary Outcomes (3)

  • 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).

    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.

    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.

    post-treatment (time 2)

Study Arms (2)

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.

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.

Interventions

Mindfulness-Based Stress ReductionBEHAVIORAL

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.

Also known as: MBSR
Mindfulness-Based Stress Reduction

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Related Publications (5)

  • 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.

    PMID: 23697871RESULT

  • 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.

    PMID: 23383976RESULT

  • 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.

    PMID: 23774986RESULT

  • 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.

    PMID: 21241793RESULT

  • 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.

    PMID: 27511921DERIVED

MeSH Terms

Conditions

Stress, Psychological

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Dr. Jan Moynihan
Organization
University of Rochester
jan_moynihan@urmc.rochester.edu
585-275-4648

Study Officials

  • Jan A Moynihan, Ph.D

    University of Rochester

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director, The Rochester Center for Mind-Body Research, University of Rochester Medical Center

Study Record Dates

First Submitted

December 6, 2009

First Posted

December 9, 2009

Study Start

March 1, 2006

Primary Completion

May 1, 2009

Study Completion

August 1, 2009

Last Updated

August 27, 2014

Results First Posted

August 27, 2014

Record last verified: 2014-01

Locations

US(1)