Mindfulness Meditation in Older Adults (MIND)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
J. David Creswell, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01532596
First received: February 8, 2012
Last updated: February 9, 2012
Last verified: February 2012
  Purpose

The purpose of this study is to test if an 8-week mindfulness meditation training (vs a wait-list control condition) program reduces neurobehavioral reactivity and improves affect regulation in a sample of older adults, as measured by functional magnetic resonance imaging. Additionally, we will examine if mindfulness meditation training reduces loneliness and markers of chronic inflammation.


Condition Intervention Phase
Aging
Behavioral: Mindfulness-Based Stress Reduction
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: The Effects of Mindfulness Meditation in Older Adults

Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Functional Neural Activity [ Time Frame: Change from Baseline to 2 months ] [ Designated as safety issue: No ]
    Neural responses to emotionally evocative stimuli


Secondary Outcome Measures:
  • Pro-inflammation [ Time Frame: Change from Baseline to 2 months ] [ Designated as safety issue: No ]
    Genetic and protein measures of inflammation

  • Loneliness [ Time Frame: Change from Baseline to 2 months ] [ Designated as safety issue: No ]
    self-reported loneliness

  • Psychological Distress [ Time Frame: Change from Baseline to 2 months ] [ Designated as safety issue: No ]
    self-reported psychological distress


Enrollment: 40
Study Start Date: January 2008
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mindfulness-Based Stress Reduction
A standardized 8-week mindfulness meditation training program
Behavioral: Mindfulness-Based Stress Reduction
8-week standardized mindfulness meditation training program
Other Name: MBSR
No Intervention: Wait-List

Detailed Description:

It is well established that mindfulness meditation interventions improve a wide-range of mental and physical health outcomes in stressed patient populations, although the underlying mechanisms are currently unknown. It has been suggested that mindfulness training may reduce reactivity to stimuli and improve regulation, although these mechanisms have not been examined (using functional neuroimaging). Additionally, it is well-established that loneliness and inflammation are major risk factors for morbidity and mortality in older adults, although it is currently unknown whether mindfulness meditation training may reduce these risk factors. The purpose of the proposed study is to test if mindfulness meditation training (vs a wait-list control condition) reduces neurobehavioral reactivity and improves affect regulation in a sample of healthy older adults, as measured by functional magnetic resonance imaging. Additionally, we will examine whether mindfulness meditation training reduces loneliness and markers of inflammation.

Participants will be recruited in the Los Angeles area and randomly assigned to the 8-week Mindfulness-Based Stress Reduction (MBSR) intervention or to a wait-list. All participants will provide a blood sample and complete a psychosocial survey before and after the intervention, and complete a 60-minute neuroimaging assessment before and after the MBSR program. All participants who are randomly assigned to the wait-list will be offered the MBSR intervention after the 8-week intervention period and then complete an additional post-test assessment after completing the MBSR program (which will include a blood sample, psychosocial survey, and a neuroimaging assessment). Participants will complete neuroimaging tasks (where they will be presented with words, pictures, and sounds) before and after receiving the MBSR intervention, which will assess neural activity and regulation responses before and after mindfulness meditation training.

  Eligibility

Ages Eligible for Study:   55 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • English-speaking adults between the ages of 55-85 years of age at time of entry
  • post-menopausal and not pregnant (women only)
  • Accessible geographically and willing to come to UCLA for all study related activities

Exclusion Criteria:

  • they have regularly (>1 time per week) practiced a mind-body therapy anytime in the last six months (e.g., meditation, yoga, tai chi)
  • are not ambulatory, (c) indicate any treatment for mental health problems in the last six months
  • indicate any major physical health problems in the last three months
  • use medications affecting cardiovascular or endocrine function
  • are left-handed
  • or have metal in their bodies (including pacemakers and permanent piercings (e.g., bellyrings), but not dental fillings)
  • indicate regular use of psychotropic medication or psychotherapy in the last six months
  • cognitive impairment as indicated by a score lower than 23 on the Mini-Mental State examination
  • smokers
  • indicate feeling claustrophobic in confined spaces, such as an fMRI scanner
  • weigh over 300 lbs
  • indicate any use of doctor prescribed cholesterol lowering medications (e.g., statins)
  • use any doctor prescribed pain medication
  • indicate any implants
  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: NCT01532596

Locations
United States, California
Cousins Center for Psychoneuroimmunology, UCLA
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
Principal Investigator: J. David Creswell, Ph.D. University of California, Los Angeles
  More Information

No publications provided

Responsible Party: J. David Creswell, Post-Doctoral Fellow, Cousins Center for Psychoneuroimmunology, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01532596     History of Changes
Other Study ID Numbers: MBSR-Older-00001
Study First Received: February 8, 2012
Last Updated: February 9, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on July 20, 2014