Clinical trial NCT01532596: Mindfulness Meditation in Older Adults
Official title: The Effects of Mindfulness Meditation in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Aging
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2012-02-14
Enrollment: 40
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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 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

Primary outcomes:
measure: Functional Neural Activity
timeFrame: Change from Baseline to 2 months
Secondary outcomes:
measure: Pro-inflammation
timeFrame: Change from Baseline to 2 months
measure: Loneliness
timeFrame: Change from Baseline to 2 months
measure: Psychological Distress
timeFrame: Change from Baseline to 2 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cousins Center for Psychoneuroimmunology, UCLA
state: California
Study officials:
affiliation: University of California, Los Angeles
name: J. David Creswell, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: