- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01532596
Mindfulness Meditation in Older Adults (MIND)
The Effects of Mindfulness Meditation in Older Adults
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
California
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Los Angeles, California, United States, 90095
- Cousins Center for Psychoneuroimmunology, UCLA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mindfulness-Based Stress Reduction
A standardized 8-week mindfulness meditation training program
|
8-week standardized mindfulness meditation training program
Other Names:
|
No Intervention: Wait-List
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Functional Neural Activity
Time Frame: Change from Baseline to 2 months
|
Neural responses to emotionally evocative stimuli
|
Change from Baseline to 2 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pro-inflammation
Time Frame: Change from Baseline to 2 months
|
Genetic and protein measures of inflammation
|
Change from Baseline to 2 months
|
Loneliness
Time Frame: Change from Baseline to 2 months
|
self-reported loneliness
|
Change from Baseline to 2 months
|
Psychological Distress
Time Frame: Change from Baseline to 2 months
|
self-reported psychological distress
|
Change from Baseline to 2 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: J. David Creswell, Ph.D., University of California, Los Angeles
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- MBSR-Older-00001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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