Mindfulness Meditation in Older Adults

Aging Clinical Trial

— MIND  

Official title:

The Effects of Mindfulness Meditation in Older Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01532596
• Other study ID #: MBSR-Older-00001
• Status: Completed
• Phase: Phase 0
• First received: February 8, 2012
• Last updated: February 9, 2012
• Start date: January 2008
• Est. completion date: January 2009

Study information

• Verified date: February 2012
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Aging

Intervention

Behavioral:
• Mindfulness-Based Stress Reduction
8-week standardized mindfulness meditation training program

Locations

Country	Name	City	State
United States	Cousins Center for Psychoneuroimmunology, UCLA	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional Neural Activity	Neural responses to emotionally evocative stimuli	Change from Baseline to 2 months	No
Secondary	Pro-inflammation	Genetic and protein measures of inflammation	Change from Baseline to 2 months	No
Secondary	Loneliness	self-reported loneliness	Change from Baseline to 2 months	No
Secondary	Psychological Distress	self-reported psychological distress	Change from Baseline to 2 months	No