AttentionEMBODYNCT03344081
Evaluating Multivariate MRI Maps of Body Awareness
An observational study of Attention, run by University of California, San Francisco at 1 site in United States.
Trial summary
Meditation skills, or paying attention to internal mental states, are thought to improve people's health. This study is developing a new brain measure of meditation skills, called the EMBODY Task, using functional magnetic resonance imaging (fMRI). Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2016to 11 Jul 2019
- Phase
- Observational
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study is designed for healthy adults, some of whom have extended meditation practice (at least 5 years), and some who have little or no meditation experience.
Who may be able to join
- Healthy adults, 25-65 years of age.
- Meditators will be affiliated with meditation centers that are based in the Vipassana tradition or Zen traditions. In the past 5 years, meditators will have a consistent practice in mindfulness of body practices, where consistent practice is defined as practicing for at least 90 minutes in a typical week. They will also have had at least 14 days of total silent retreat practice in the past 5 years. At least half of total practice time as reported by the participants will be engaged in mindfulness of body practices (e.g., breath meditation, body scan, mindfulness of emotions, mindful yoga, walking meditation).
- Non-meditator control group. Within the past 3 years, participants will not have engaged in regular meditation (including from courses such as Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy, and Dialectical Behavioral Therapy), yoga, or other mind-body practice (such as Tai Chi, Feldenkrais, sensory awareness, or related practices), defined as more than 20 minutes of practice at least two times per week. If there is experience with mind-body practices prior to the past 3 years, it should not include an extended period of consistent practice (such as 20 min daily practice for a year or more) or a period of intensive practice longer than 7 days (e.g., 10-day silent retreat).
Who cannot join
- Participants who endorse:
- being smokers;
- chronic or recurrent bronchial or pulmonary disease requiring medical attention;
- having been diagnosed with sleep apnea;
- a history of an upper or lower respiratory tract infection in the 6 weeks preceding the study;
- pregnancy;
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- diseases that restrain chest or abdominal breathing, such as ankylosing spondylitis, systemic lupus, chronic abdominal pain, chronic liver or kidney diseases,
- can not fit comfortably in the MRI scanner.
- potentially confounding medical conditions that impact breathing (e.g.,asthma, congestive heart failure, and emphysema that are not well-controlled), could impact attention to the breath (e.g., chronic pain conditions that are not well-managed), or impact neural functioning (e.g., multiple sclerosis, neurological diseases, brain injury);
- currently experiencing a mental health condition (e.g., anxiety, depression, panic disorder, post-traumatic stress disorder, attention deficit and hyperactivity disorder) or past severe mental illness such as bipolar disorder, schizophrenia, or severe substance abuse disorder.
- use of psychotropic medications in the past year
- current use of medications that potentially can affect the respiratory system or the interoceptive focus in the past week (including narcotics, benzodiazepines); if the research assistant is unclear about a specific medication, the physician on the study (Dr. Rick Hecht) will be asked and will decide;
- health behaviors that could affect respiration (e.g., DSM-IV diagnosis of substance use disorder, use of major recreational drugs in the past year-heroin, cocaine, etc.);
- any high-level training in a field that could impact body awareness and is not associated with mind-body practices (e.g., professional athletes or dancers, marathon runners);
- lack of ability to speak and read English fluently (instructions and questionnaires will be in English only and foreign language translations will have to await future studies);
- For participants who consent to the fMRI study, exclusion criteria include contra-indications for safety and data quality in the MRI scanner (see MRI screening form): presence of ferromagnetic metal on or in the body, pregnancy, movement disorder which prevents lying still in the scanner, claustrophobia, braces, and corrected vision that is not within +/- 8.
Trial locations and contacts
1 site in 1 country.
United States1 site
Osher Center for Integrative Medicine
San Francisco, California, 94117
About this study
Official title: Evaluating Multivariate MRI Maps of Body Awareness: A Pilot Functional Magnetic Resonance Imaging (fMRI) Study of Breath Meditation
Meditation skills, or paying attention to internal mental states, are thought to improve people's health. This study is developing a new brain measure of meditation skills, called the EMBODY Task, using functional magnetic resonance imaging (fMRI). The investigators are testing whether pattern recognition methods can be applied to fMRI data to identify mental states during meditation, including attention to the body and to thoughts. This task is being developed in meditation practitioners and non-meditators. The goal is to understand what people are paying attention to during meditation using brain data. The investigators hypothesize that pattern recognition technology will be able to identify different mental states that occur during meditation.
Read the detailed description
The investigators are developing a new functional magnetic resonance imaging (fMRI) task (the EMBODY Task) to measure mental states during meditation using pattern recognition or machine learning technology. This task is being piloted and validated in 20 meditators and 20 control participants, in two waves of pilot testing. Meditators will have practiced meditation for at least the 5 years, at least 90 minutes weekly. Control participants will have little to no meditation experience and will be age- and gender-matched to each meditator. All participants will be MRI-compatible, healthy with no health conditions that affect breathing, have no current psychiatric disorder, and not be taking psychotropic medications.
In the EMBODY Task, participants will be instructed to pay attention to areas of the body, their thoughts, sounds in the scanner, and to stop paying attention, in short intervals (16-45s). They will also meditate on their breath for 10 minutes. The investigators will determine whether pattern recognition technology can distinguish 5 mental states, and whether these brain patterns can be used to identify mental states during meditation. The investigators hypothesize that all 5 mental states will be distinguished by pattern recognition in the meditators, and potentially in the controls. Investigators also hypothesize that meditators should pay attention to their breath longer during meditation compared to controls.
- Conditions
- Attention
- Keywords
- attention, interoception, meditation, mind wandering
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Meditators | Meditators will have practiced meditation for at least the 5 years, at least 90 minutes weekly. They will have completed at least 14 days of retreat practice in the past 5 years. At least half of their meditation practice will include attention to the breath and body. All participants will be MRI-compatible, healthy with no health conditions that affect breathing, have no current psychiatric disorder, and not be taking psychotropic medications. | |
| Controls | Control participants will be age- and gender-matched to each meditators. They will have little to no previous meditation experience. All participants will be MRI-compatible, healthy with no health conditions that affect breathing, have no current psychiatric disorder, and not be taking psychotropic medications. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Classification accuracy of brain patterns from EMBODY Task
The EMBODY Task is a new brain-based measure using functional magnetic resonance imaging (fMRI) to measure meditation skills. The primary outcome measure of the EMBODY Task is whether brain patterns are recognized by pattern classification algorithms for the 5 conditions in the study (attention to breath, body, mind wandering, thoughts, and sounds) above chance levels (20% for 5 conditions, using a one-sample t-test for each condition in the entire sample). Classification accuracy is a standard outcome measure in studies that use brain pattern classification. This will demonstrate that brain patterns associated with internal attention are indeed differentiable by pattern classification methods. These brain patterns will then be used to identify the focus of attention during breath meditation.
Measured: Outcome measure will be assessed once at the baseline fMRI scan to develop the pilot fMRI task.
Secondary outcomes (2)
Percentage time paying attention to breath during meditation
Using EMBODY Task metrics, investigators will calculate how much time people pay attention to their breath during meditation
Measured: Outcome measure will be assessed once at the baseline fMRI scan to develop the pilot fMRI task.
Percentage time spent mind wandering during meditation
Using EMBODY Task metrics, investigators will calculate how much time people were mind wandering during meditation
Measured: Outcome measure will be assessed once at the baseline fMRI scan to develop the pilot fMRI task.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Jun 2016
- Primary completion11 Jul 2019
- Study completion11 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AttentionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Mind and Life Institute, Hadley, Massachusetts
- Responsible party
- Sponsor
- Investigators
- Helen Y Weng, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03344081
- Sponsor's protocol ID
- 15-16716
- Other IDs
- K08AT009385
- Acronym
- EMBODY
- Status last verified
- Sep 2021
- First submitted
- 26 Sep 2017
- Last updated
- 16 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Investigators plan to pilot and develop the fMRI EMBODY Task to measure meditation skills, and share any protocols, scripts, and analytic code to administer and analyze the task.
Publications
Weng HY, Lewis-Peacock JA, Hecht FM, Uncapher MR, Ziegler DA, Farb NAS, Goldman V, Skinner S, Duncan LG, Chao MT, Gazzaley A. Focus on the Breath: Brain Decoding Reveals Internal States of Attention During Meditation. Front Hum Neurosci. 2020 Aug 28;14:336. doi: 10.3389/fnhum.2020.00336. eCollection 2020.
PubMed 33005138
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Multivariate MRI Maps of Body Awareness: A Pilot Functional Magnetic Resonance Imaging (fMRI) Study of Breath Meditation
- ClinicalTrials.gov ID
- NCT03344081
- Acronym / sponsor ID
- EMBODY / 15-16716
- Conditions
- Attention
- Keywords
- attention, interoception, meditation, mind wandering
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH), Mind and Life Institute, Hadley, Massachusetts
- Study start
- 1 Jun 2016 (actual)
- Primary completion
- 11 Jul 2019 (actual)
- Study completion
- 11 Jul 2019 (actual)
- First posted
- 17 Nov 2017 (actual)
- 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.
Meditation skills, or paying attention to internal mental states, are thought to improve people's health. This study is developing a new brain measure of meditation skills, called the EMBODY Task, using functional magnetic resonance imaging (fMRI). The investigators are testing whether pattern recognition methods can be applied to fMRI data to identify mental states during meditation, including attention to the body and to thoughts. This task is being developed in meditation practitioners and non-meditators. The goal is to understand what people are paying attention to during meditation using brain data. The investigators hypothesize that pattern recognition technology will be able to identify different mental states that occur during meditation.
Detailed description
The investigators are developing a new functional magnetic resonance imaging (fMRI) task (the EMBODY Task) to measure mental states during meditation using pattern recognition or machine learning technology. This task is being piloted and validated in 20 meditators and 20 control participants, in two waves of pilot testing. Meditators will have practiced meditation for at least the 5 years, at least 90 minutes weekly. Control participants will have little to no meditation experience and will be age- and gender-matched to each meditator. All participants will be MRI-compatible, healthy with no health conditions that affect breathing, have no current psychiatric disorder, and not be taking psychotropic medications.
In the EMBODY Task, participants will be instructed to pay attention to areas of the body, their thoughts, sounds in the scanner, and to stop paying attention, in short intervals (16-45s). They will also meditate on their breath for 10 minutes. The investigators will determine whether pattern recognition technology can distinguish 5 mental states, and whether these brain patterns can be used to identify mental states during meditation. The investigators hypothesize that all 5 mental states will be distinguished by pattern recognition in the meditators, and potentially in the controls. Investigators also hypothesize that meditators should pay attention to their breath longer during meditation compared to controls.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meditators | – | –Meditators will have practiced meditation for at least the 5 years, at least 90 minutes weekly. They will have completed at least 14 days of retreat practice in the past 5 years. At least half of their meditation practice will include attention to the breath and body. All participants will be MRI-compatible, healthy with no health conditions that affect breathing, have no current psychiatric disorder, and not be taking psychotropic medications. |
| Controls | – | –Control participants will be age- and gender-matched to each meditators. They will have little to no previous meditation experience. All participants will be MRI-compatible, healthy with no health conditions that affect breathing, have no current psychiatric disorder, and not be taking psychotropic medications. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study is designed for healthy adults, some of whom have extended meditation practice (at least 5 years), and some who have little or no meditation experience.
Key inclusion criteria (3 listed)
- Healthy adults, 25-65 years of age.
- Meditators will be affiliated with meditation centers that are based in the Vipassana tradition or Zen traditions. In the past 5 years, meditators will have a consistent practice in mindfulness of body practices, where consistent practice is defined as practicing for at least 90 minutes in a typical week. They will also have had at least 14 days of total silent retreat practice in the past 5 years. At least half of total practice time as reported by the participants will be engaged in mindfulness of body practices (e.g., breath meditation, body scan, mindfulness of emotions, mindful yoga, walking meditation).
- Non-meditator control group. Within the past 3 years, participants will not have engaged in regular meditation (including from courses such as Mindfulness-Based Stress Reduction, Mindfulness-Based Cognitive Therapy, and Dialectical Behavioral Therapy), yoga, or other mind-body practice (such as Tai Chi, Feldenkrais, sensory awareness, or related practices), defined as more than 20 minutes of practice at least two times per week. If there is experience with mind-body practices prior to the past 3 years, it should not include an extended period of consistent practice (such as 20 min daily practice for a year or more) or a period of intensive practice longer than 7 days (e.g., 10-day silent retreat).
Key exclusion criteria (16 listed)
- being smokers;
- chronic or recurrent bronchial or pulmonary disease requiring medical attention;
- having been diagnosed with sleep apnea;
- a history of an upper or lower respiratory tract infection in the 6 weeks preceding the study;
- pregnancy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Classification accuracy of brain patterns from EMBODY Task
Time frame: Outcome measure will be assessed once at the baseline fMRI scan to develop the pilot fMRI task.
The EMBODY Task is a new brain-based measure using functional magnetic resonance imaging (fMRI) to measure meditation skills. The primary outcome measure of the EMBODY Task is whether brain patterns are recognized by pattern classification algorithms for the 5 conditions in the study (attention to breath, body, mind wandering, thoughts, and sounds) above chance levels (20% for 5 conditions, using a one-sample t-test for each condition in the entire sample). Classification accuracy is a standard outcome measure in studies that use brain pattern classification. This will demonstrate that brain patterns associated with internal attention are indeed differentiable by pattern classification methods. These brain patterns will then be used to identify the focus of attention during breath meditation.
2 secondary outcomes
Percentage time paying attention to breath during meditation
Time frame: Outcome measure will be assessed once at the baseline fMRI scan to develop the pilot fMRI task.
Percentage time spent mind wandering during meditation
Time frame: Outcome measure will be assessed once at the baseline fMRI scan to develop the pilot fMRI task.
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 16 Sep 2021.
- Results publication: PubMed 33005138Weng HY, Lewis-Peacock JA, Hecht FM, Uncapher MR, Ziegler DA, Farb NAS, Goldman V, Skinner S, Duncan LG, Chao MT, Gazzaley A. Focus on the Breath: Brain Decoding Reveals Internal States of Attention During Meditation. Front Hum Neurosci. 2020 Aug 28;14:336. doi: 10.3389/fnhum.2020.00336. eCollection 2020.
- Individual participant dataSharing planned: Yes. Investigators plan to pilot and develop the fMRI EMBODY Task to measure meditation skills, and share any protocols, scripts, and analytic code to administer and analyze the task.
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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.
Helen Y Weng, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention, run by University of California, San Francisco 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 16 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 16 Sep 2021. 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?
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?
Classification accuracy of brain patterns from EMBODY Task (time frame: Outcome measure will be assessed once at the baseline fMRI scan to develop the pilot fMRI task.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03344081, which also lists 1 linked publication.
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 16 Sep 2021.