No ConditionNCT00379210
Neural Effects of Mindfulness Training on Attention
A study testing Mindfulness Meditation Training (MMT) and Nutrition Education course in people with No Condition and Focus is Neural Effects of Mindfulness Training on Attention, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of this study is to examine behavioral and neural changes resulting from Mindfulness Meditation Training (MMT), and to use this knowledge in advancing our understanding of the mechanisms of attention. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- No Condition, Focus is Neural Effects of Mindfulness Training on Attention
- What is being tested?
- Mindfulness Meditation Training (MMT) and Nutrition Education course
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2006to Aug 2009
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women (all races and ethnicities) between 18 and 40 years old
- Women of childbearing age with a negative pregnancy test within 48 hours of scanning
- In good health
- Right-handed
- Normal or corrected-to-normal vision
- English as a first language
Show all 9Show fewer
- Able to understand and provide signed informed consent
- No history of metal in their body or other reasons why they could not undergo an Magnetic Resonance Imaging
- No history of ischemic or hemorrhagic stroke, encephalopathy or encephalitis, minimal-cognitive impairment or dementia, movement disorder such as Parkinson's disease, head trauma causing loss of consciousness, cancer involving the central nervous system
Who cannot join
- Pregnant or breast-feeding women
- Individuals with implanted metal or electronic devices that would prevent them from MRI scanning.
- Individuals with a history of neurologic dysfunction that would prevent performance on attentional tasks including: history of transient ischemic attacks, history of cerebral infarction, history of Binswanger's disease (or a history of hypertensive encephalopathy), history of intracranial hemorrhage, history of head trauma with loss of consciousness, history of encephalitis, history of extended exposure to any known neurotoxin, history of acquired cognitive impairment, history of normal pressure hydrocephalus, history of a cancer metastatic to the central nervous system, history of Parkinson's or other basal ganglia disease, history of Guillain-Barré syndrome or chronic or relapsing polyneuropathy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
The purpose of this study is to examine behavioral and neural changes resulting from Mindfulness Meditation Training (MMT), and to use this knowledge in advancing our understanding of the mechanisms of attention.
Read the detailed description
Mindfulness Meditation Training (MMT) has been used successfully to decrease stress, pain, and adverse health symptoms in a varied subject population. MMT has been described as "paying attention in a particular way." Although attention is a key component of meditation, little is known about the cognitive and neural changes within the human attention system that result from MMT. In this study, we examine the effects of MMT on the human attention system using neurobehavioral measures. Here MMT comprises participation in a Mindfulness-Based-Stress-Reduction (MBSR) course, while the comparison group participates in a nutrition education course, both 8 weeks long. We compare the performance and neural activity of these groups both before and after participation in the course.
- Being tested
- Mindfulness Meditation Training (MMT), Nutrition Education course
- Keywords
- Attention, ERP, event-related potentials, fMRI, functional magnetic resonance imaging, MBSR, Mindfulness Based Stress Reduction, Mindfulness Meditation Training, MMT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Meditation Training (MMT)Behavioural
Also called MBSR, Mindfulness-Based Stress Reduction
8-week training course in mindfulness meditation
Nutrition Education courseBehavioural
8-week course in nutrition
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Meditation training group-- received Mindfulness Based Stress Management from the Penn Program for Stress Management.
The meditation practice initially emphasized attention to a single focus. For most concentrative exercises, this focus was the breath. The sensations of breathing were to be examined closely, and when attention wandered it was to be redirected back to the breath. In other exercises, the focus of attention was to be directed to sensations within specific body parts (body scan exercise) and sensations of walking (walking meditation). During the 5th week of classes, the mindfulness training was expanded to include some explicit training in receptive attention. Receives: Behavioral: Mindfulness Meditation Training (MMT) |
| 2 | Active comparator | Nutrition education group
An active comparison condition involving nutrition education was offered. This course matched the mindfulness course in all dimensions including course duration, homework, psychosocial support, and teacher expertise. The course was taught by a nurse who had expertise in nutrition and offered a program described in the book, Nutrition for Life by Lisa Hark. Receives: Behavioral: Nutrition Education course |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reaction Times on the Sustained Attention to Response Task.
Single digits (0-9) are flashed on the screen one by one. The number 3 is the target and all other digits are non-targets. The participant is asked to press the space bar for nontargets and withhold from pressing the space bar for the target.
Measured: 9 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2006 (estimated)
- Study startSep 2006
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for No ConditionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
- Investigators
- Amishi P Jha, Ph.D., Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00379210
- Sponsor's protocol ID
- R21AT002761-01A1
- Other IDs
- R21AT002761-01A1, 10012037
- Status last verified
- Nov 2007
- First submitted
- 20 Sep 2006
- Last updated
- 26 Jan 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Effects of Mindfulness Training on Attention
- ClinicalTrials.gov ID
- NCT00379210
- Acronym / sponsor ID
- R21AT002761-01A1
- Keywords
- Attention, ERP, event-related potentials, fMRI, functional magnetic resonance imaging, MBSR, Mindfulness Based Stress Reduction, Mindfulness Meditation Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Sep 2006
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 21 Sep 2006 (estimated)
- Results
- Posted 26 Jan 2012
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 examine behavioral and neural changes resulting from Mindfulness Meditation Training (MMT), and to use this knowledge in advancing our understanding of the mechanisms of attention.
Detailed description
Mindfulness Meditation Training (MMT) has been used successfully to decrease stress, pain, and adverse health symptoms in a varied subject population. MMT has been described as "paying attention in a particular way." Although attention is a key component of meditation, little is known about the cognitive and neural changes within the human attention system that result from MMT. In this study, we examine the effects of MMT on the human attention system using neurobehavioral measures. Here MMT comprises participation in a Mindfulness-Based-Stress-Reduction (MBSR) course, while the comparison group participates in a nutrition education course, both 8 weeks long. We compare the performance and neural activity of these groups both before and after participation in the course.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Mindfulness Meditation Training (MMT)Meditation training group-- received Mindfulness Based Stress Management from the Penn Program for Stress Management. The meditation practice initially emphasized attention to a single focus. For most concentrative exercises, this focus was the breath. The sensations of breathing were to be examined closely, and when attention wandered it was to be redirected back to the breath. In other exercises, the focus of attention was to be directed to sensations within specific body parts (body scan exercise) and sensations of walking (walking meditation). During the 5th week of classes, the mindfulness training was expanded to include some explicit training in receptive attention. |
| 2 | Active comparator | Behavioral: Nutrition Education courseNutrition education group An active comparison condition involving nutrition education was offered. This course matched the mindfulness course in all dimensions including course duration, homework, psychosocial support, and teacher expertise. The course was taught by a nurse who had expertise in nutrition and offered a program described in the book, Nutrition for Life by Lisa Hark. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Men and women (all races and ethnicities) between 18 and 40 years old
- Women of childbearing age with a negative pregnancy test within 48 hours of scanning
- In good health
- Right-handed
- Normal or corrected-to-normal vision
Key exclusion criteria (3 listed)
- Pregnant or breast-feeding women
- Individuals with implanted metal or electronic devices that would prevent them from MRI scanning.
- Individuals with a history of neurologic dysfunction that would prevent performance on attentional tasks including: history of transient ischemic attacks, history of cerebral infarction, history of Binswanger's disease (or a history of hypertensive encephalopathy), history of intracranial hemorrhage, history of head trauma with loss of consciousness, history of encephalitis, history of extended exposure to any known neurotoxin, history of acquired cognitive impairment, history of normal pressure hydrocephalus, history of a cancer metastatic to the central nervous system, history of Parkinson's or other basal ganglia disease, history of Guillain-Barré syndrome or chronic or relapsing polyneuropathy
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 Meditation Training (MMT)Also: MBSR, Mindfulness-Based Stress Reduction8-week training course in mindfulness meditation | Behavioural | 1 |
| Nutrition Education course8-week course in nutrition | Behavioural | 2 |
Primary outcome
Reaction Times on the Sustained Attention to Response Task.
Time frame: 9 weeks
Single digits (0-9) are flashed on the screen one by one. The number 3 is the target and all other digits are non-targets. The participant is asked to press the space bar for nontargets and withhold from pressing the space bar for the target.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Laboratory of Dr. Amishi JhaLink provided by the sponsor.
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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.
Amishi P Jha, Ph.D. principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Meditation Training (MMT) and Nutrition Education course in people with No Condition and Focus is Neural Effects of Mindfulness Training on Attention, run by University of Pennsylvania 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 9 inclusion and 3 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 26 Jan 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Reaction Times on the Sustained Attention to Response Task. (time frame: 9 weeks). 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 26 Jan 2012.