Mindfulness to Improve Elders' Immune and Health Status

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
University of Rochester
ClinicalTrials.gov Identifier:
NCT01027780
First received: December 6, 2009
Last updated: December 8, 2009
Last verified: November 2009
  Purpose

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.


Condition Intervention
Stress, Psychologic
Behavioral: Mindfulness-Based Stress Reduction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Mindfulness to Improve Elders' Immune and Health Status

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • 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, 3- and 24- week follow-ups ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Perceived Stress Scale (Cohen S., Kamarck T., & Mermelstein R. (1983)) [ Time Frame: Immediate pre/post-treatment, 3- and 24- week follow-ups ] [ Designated as safety issue: No ]
  • Mindful Attention Awareness Scale (Brown, K. W., & Ryan, R. M. (2003)) [ Time Frame: Immediate pre/post-treatment, 3- and 24- week follow-ups ] [ Designated as safety issue: No ]
  • Physical health status as potential moderator of treatment effects—including medical history, symptom checklist, CHAMPS Physical Activity Questionnaire for Older Adults (Stewart, A. L., et. al. (2001)) [ Time Frame: Immediate pre/post-treatment, 3- and 24- week follow-ups ] [ Designated as safety issue: No ]
  • Mood as potential mediator or moderator of treatment effects—including Hamilton Depression Rating Scale (HDRS); Center for Epidemiologic Studies Depression Scale, revised (CESD-R) [ Time Frame: Immediate pre/post-treatment, 3- and 24- week follow-ups ] [ Designated as safety issue: No ]
  • Personality traits as potential moderators of treatment effects (NEO-FFI; Mccrae, R. R., & Costa, P. T. (1992)) [ Time Frame: pre-treatment ] [ Designated as safety issue: No ]

Enrollment: 208
Study Start Date: March 2006
Study Completion Date: August 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Behavioral: Mindfulness-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.
Other Names:
  • Mindfulness-Based Stress Reduction
  • MBSR
No Intervention: Wait-list control
Wait-list control participants were offered MBSR training after completion of their primary assessments periods.

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.
  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01027780

Locations
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Jan A Moynihan, Ph.D University of Rochester
  More Information

No publications provided

Responsible Party: Jan A. Moynihan, Ph.D / Director, The Rochester Center for Mind-Body Research, University of Rochester Medical Center
ClinicalTrials.gov Identifier: NCT01027780     History of Changes
Other Study ID Numbers: 1R01AG025474, R01AG025474
Study First Received: December 6, 2009
Last Updated: December 8, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Rochester:
Mindfulness-Based Stress Reduction
MBSR
Seniors
immune system
keyhole limpet hemocyanin (KLH)

Additional relevant MeSH terms:
Stress, Psychological
Behavioral Symptoms
Keyhole-limpet hemocyanin
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 19, 2014