AgingEarly Phase 1MINDNCT01532596
Mindfulness Meditation in Older Adults
A Early Phase 1 study testing Mindfulness-Based Stress Reduction in people with Aging, run by University of California, Los Angeles at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Mindfulness-Based Stress Reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Jan 2009
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cousins Center for Psychoneuroimmunology, UCLA
Los Angeles, California, 90095
About this study
Official title: The Effects of Mindfulness Meditation in Older Adults
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.
Read the 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.
- Conditions
- Aging
- Being tested
- Mindfulness-Based Stress Reduction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-Based Stress ReductionBehavioural
Also called MBSR
8-week standardized mindfulness meditation training program
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Stress Reduction | Experimental | A standardized 8-week mindfulness meditation training program Receives: Behavioral: Mindfulness-Based Stress Reduction |
| Wait-List | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Neural Activity
Neural responses to emotionally evocative stimuli
Measured: Change from Baseline to 2 months
Secondary outcomes (3)
Pro-inflammation
Genetic and protein measures of inflammation
Measured: Change from Baseline to 2 months
Loneliness
self-reported loneliness
Measured: Change from Baseline to 2 months
Psychological Distress
self-reported psychological distress
Measured: Change from Baseline to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2012 (estimated)
- Study startJan 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, J. David Creswell, University of California, Los Angeles
- Investigators
- J. David Creswell, Ph.D., Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01532596
- Sponsor's protocol ID
- MBSR-Older-00001
- Acronym
- MIND
- Status last verified
- Feb 2012
- First submitted
- 8 Feb 2012
- Last updated
- 14 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Mindfulness Meditation in Older Adults
- ClinicalTrials.gov ID
- NCT01532596
- Acronym / sponsor ID
- MIND / MBSR-Older-00001
- Conditions
- Aging
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 14 Feb 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Stress Reduction | Experimental | Behavioral: Mindfulness-Based Stress ReductionA standardized 8-week mindfulness meditation training program |
| Wait-List | No intervention | – |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness-Based Stress ReductionAlso: MBSR8-week standardized mindfulness meditation training program | Behavioural | Mindfulness-Based Stress Reduction |
Primary outcome
Functional Neural Activity
Time frame: Change from Baseline to 2 months
Neural responses to emotionally evocative stimuli
3 secondary outcomes
Pro-inflammation
Time frame: Change from Baseline to 2 months
Loneliness
Time frame: Change from Baseline to 2 months
Psychological Distress
Time frame: Change from Baseline to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. David Creswell, Ph.D. principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Mindfulness-Based Stress Reduction in people with Aging, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Neural Activity (time frame: Change from Baseline to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2012.