Intensive Meditation in Novice and Experienced MeditatorsIMAGINENCT06615531
Integrating Magnetic Imaging With Rich Phenotypes
An observational study of Intensive Meditation in Novice and Experienced Meditators, run by Tobias Moeller-Bertram at 1 site in United States.
Trial summary
This study will be focused on assessing the molecular, physiological, neuroimaging, and emotional correlates of a week-long intensive meditation retreat experience in a 20-person cohort comprised of healthy participants. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Intensive Meditation in Novice and Experienced Meditators
- What is being tested?
- Advanced multi-component meditation practice
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Mar 2022to 6 May 2023
- 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 21 years and older
- All sexes
- Adult, Older adult
Study population: All study participants are registered for the advanced meditation retreat.
Who may be able to join
- Must be 21 years of age or older
- Must speak English
- Must be a registered attendee of the advanced week-long meditation retreat
- Must be in generally good health
- Must agree to provide blood and buccal samples before and after the retreat
- Must be willing to wear a Garmin device for the entire retreat
Show all 10Show fewer
- Must agree to fMRI scans before and after the retreat
- Must agree to qEEG measurements before, during, and after the retreat
- Must complete the research consent in its entirety
- Must be willing to complete self-report surveys for physical and emotional well-being
Who cannot join
- Younger than 21 years of age
- Non-English speaking
- Not a registered attendee of the advanced week-long meditation retreat
- Not willing to complete the research consent
- Has a serious health condition
- Not willing to provide blood or buccal samples
Show all 10Show fewer
- Does not agree to fMRI scans
- Not willing to wear a Garmin watch
- Does not agree to qEEG measurements
- Not willing or able to complete all self-report surveys
Trial locations and contacts
1 site in 1 country.
United States1 site
VitaMed Research, LLC
Palm Desert, California, 92260
About this study
Official title: Effects of Meditation on Human Well Being
This study will be focused on assessing the molecular, physiological, neuroimaging, and emotional correlates of a week-long intensive meditation retreat experience in a 20-person cohort comprised of healthy participants.
Read the detailed description
Mind-body interventions including meditation, reconceptualization, and placebo have been shown to improve a broad range of physical and mental health outcomes in both healthy and patient populations. How and what humans think about their health has a significant and quantifiable impact.
Placebo effects, another mind-body technique that creates health improvements, have been shown to impact every major organ system. More recently, open-label placebos, placebos administered without concealment such that the subject is aware of the placebo, have been shown to be effective for a host of health conditions. Open-label placebo effects demonstrate that placebo responses are surprisingly not dependent on deception, positive expectation, or conditioning.
Meditation, yet another mind-body intervention, has been shown to reduce pain, inflammation, stress, anxiety, depression, and to improve immune function, and emotional regulation. Different meditation techniques can produce mystical-type experiences-non-ordinary perceptual, cognitive, and affective states in which the distinction between the perceiver and the perceived is transcended. The specific pathways through which meditation promotes physical and mental health are not yet well understood, but meditation-induced changes in neural activity and on the immune and autonomic nervous systems, as well as meditation-induced molecular changes in gene expression and on the proteome and metabolome suggest that these are both broad and profound.
While each of these mind-body interventions has been studied individually, the combination of meditation, reconceptualization, and open label placebo and their combined effect on health, neural activity, and molecular physiology have never been jointly studied. This exploratory observational study will employ psychometric health questionnaires; functional magnetic resonance imaging (fMRI); quantitative electroencephalography (qEEG); and blood plasma-based real time cell metabolic analysis, quantitative assessment of neurite outgrowth, and high-throughput transcriptomics, proteomics, and metabolomics to investigate the joint neural and biological effects of these three mind-body interventions in a 7-day retreat setting.
- Being tested
- Advanced multi-component meditation practice
- Keywords
- Meditation, Mind-body interventions, Functional magnetic resonance imaging, Quantitative electroencephalography, Enzyme-linked immunosorbent assay, Metabolome, Proteome, Exosomes, Mystical experiences, Neurite outgrowth, Machine learning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Advanced multi-component meditation practiceBehavioural
The study intervention is a multi-component advanced guided meditation practice that incorporates elements of focused attention, non-dual, and loving kindness and compassion meditation techniques as well as breathwork components. The practice includes sitting, lying down, standing, and walking components and is carried out at 7-day advanced meditation retreats lead by Joe Dispenza, D.C. These retreats include lecture-based instruction and up to 35 hours of meditation practice.
| Study group | Role | What they receive |
|---|---|---|
| Single group study | Dr Joe Dispenza Week Long Advanced Retreat Attendees Receives: Behavioral: Advanced multi-component meditation practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional brain changes as monitored by functional magnetic resonance imaging (fMRI) following an intensive week-long meditation retreat
fMRI scans will be taken on subjects during two conditions (rest and a 15-minute meditation) before and after the week-long retreat to assess changes in brain functional connectivity associated with meditation (meditation vs rest) and resulting from the retreat (pre vs post). It is expected that whole-brain functional connectivity will become more integrated during meditation as well as after the week-long retreat. Resting state network connectivity will be assessed, and it is expected that default mode network (DMN) intra-network connectivity will decrease during meditation and more so post-retreat.
Measured: 1 week
Mystical Experience Questionnaire (MEQ)-30 scores before and after an intensive week-long meditation retreat
Subjects will be given the MEQ-30 survey following a 15-minute scanner meditation before and after the retreat. An increase in MEQ-30 score is indicative of a higher shift in consciousness and presumably to a more favorable psychological state. Scores will be correlated to functional brain changes.
Measured: 1 week
Brain activity changes as assessed by quantitative EEQ (qEEG) before and after an intensive week-long meditation retreat.
Brain scans will be collected by qEEG on all subjects during a 15-minute meditation before and after the retreat to assess brain complexity. It is expected that brain complexity will increase after the week-long retreat.
Measured: 1 week
Blood plasma proteomic and metabolomic analysis before and after an intensive week-long meditation retreat.
An integrative analysis of proteomic and metabolomic expression in blood plasma will be carried out in samples collected before and after the retreat. The expectation is that shifts in biological processes toward an improved state of health will occur after the week-long retreat.
Measured: 1 week
Secondary outcomes (2)
Heart rate variability changes during a week-long meditation retreat
Heart rate data will be collected using a Garmin wristwatch at the beginning of the meditation retreat and continuously throughout the week-long retreat. Beat-to-beat interval data will be used to calculate heart rate variability. Time domain measures will include the mean of R-R intervals (mRR), standard deviation of all R-R intervals (SDRR), root mean square of successive R-R differences (RMSSD), and the percentage of R-R intervals that vary by at least 50 ms (pRR50). Frequency domain measures will include very low frequency (VLF), low frequency (LF), and high frequency (HF) measures.
Measured: 1 week
Effect of meditation-conditioned blood on neurite outgrowth
Human plasma collected before and after the retreat will be used to treat differentiated Phaeochromocytoma 12 (PC12) cells. Live cell imaging will be carried out to quantify neurite outgrowth. The expectation is that meditation-conditioned (post-retreat) plasma will lead to greater neurite outgrowth than unconditioned (pre-retreat) plasma.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start23 Mar 2022
- Primary completion6 May 2023
- Study completion6 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Intensive Meditation in Novice and Experienced MeditatorsStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tobias Moeller-Bertram
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Metamorphosis, LLC, University of California, San Diego
- Responsible party
- Sponsor-investigator, Tobias Moeller-Bertram, VitaMed Research LLC
- Investigators
- Tobias Moeller-Bertram, MD, Principal investigator, VitaMed Research LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06615531
- Sponsor's protocol ID
- 20211477B
- Acronym
- IMAGINE
- Status last verified
- Oct 2024
- First submitted
- 23 Sep 2024
- Last updated
- 10 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Publications
Zeidan F, Martucci KT, Kraft RA, Gordon NS, McHaffie JG, Coghill RC. Brain mechanisms supporting the modulation of pain by mindfulness meditation. J Neurosci. 2011 Apr 6;31(14):5540-8. doi: 10.1523/JNEUROSCI.5791-10.2011.
PubMed 21471390Ng TKS, Fam J, Feng L, Cheah IK, Tan CT, Nur F, Wee ST, Goh LG, Chow WL, Ho RC, Kua EH, Larbi A, Mahendran R. Mindfulness improves inflammatory biomarker levels in older adults with mild cognitive impairment: a randomized controlled trial. Transl Psychiatry. 2020 Jan 21;10(1):21. doi: 10.1038/s41398-020-0696-y.
PubMed 32066726Khoury B, Knauper B, Schlosser M, Carriere K, Chiesa A. Effectiveness of traditional meditation retreats: A systematic review and meta-analysis. J Psychosom Res. 2017 Jan;92:16-25. doi: 10.1016/j.jpsychores.2016.11.006. Epub 2016 Nov 18.
PubMed 27998508Oyler, D. L. et al. The Influence of Meditative Interventions on Immune Functioning: A Meta-Analysis. Mindfulness 14, 1815-1851 (2023).
de Castro JM. Meditation has stronger relationships with mindfulness, kundalini, and mystical experiences than yoga or prayer. Conscious Cogn. 2015 Sep;35:115-27. doi: 10.1016/j.concog.2015.04.022. Epub 2015 May 22.
PubMed 26002763Afonso RF, Kraft I, Aratanha MA, Kozasa EH. Neural correlates of meditation: a review of structural and functional MRI studies. Front Biosci (Schol Ed). 2020 Mar 1;12(1):92-115. doi: 10.2741/S542.
PubMed 32114450Tang YY, Ma Y, Fan Y, Feng H, Wang J, Feng S, Lu Q, Hu B, Lin Y, Li J, Zhang Y, Wang Y, Zhou L, Fan M. Central and autonomic nervous system interaction is altered by short-term meditation. Proc Natl Acad Sci U S A. 2009 Jun 2;106(22):8865-70. doi: 10.1073/pnas.0904031106. Epub 2009 May 18.
PubMed 19451642Buric I, Farias M, Jong J, Mee C, Brazil IA. What Is the Molecular Signature of Mind-Body Interventions? A Systematic Review of Gene Expression Changes Induced by Meditation and Related Practices. Front Immunol. 2017 Jun 16;8:670. doi: 10.3389/fimmu.2017.00670. eCollection 2017.
PubMed 28670311Xue T, Chiao B, Xu T, Li H, Shi K, Cheng Y, Shi Y, Guo X, Tong S, Guo M, Chew SH, Ebstein RP, Cui D. The heart-brain axis: A proteomics study of meditation on the cardiovascular system of Tibetan Monks. EBioMedicine. 2022 Jun;80:104026. doi: 10.1016/j.ebiom.2022.104026. Epub 2022 May 13.
PubMed 35576643Chen, W. et al. Comprehensive Metabolomic and Lipidomic Analysis Reveals Metabolic Changes After Mindfulness Training. Mindfulness 11, 1390-1400 (2020).
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Meditation on Human Well Being
- ClinicalTrials.gov ID
- NCT06615531
- Acronym / sponsor ID
- IMAGINE / 20211477B
- Keywords
- Meditation, Mind-body interventions, Functional magnetic resonance imaging, Quantitative electroencephalography, Enzyme-linked immunosorbent assay, Metabolome, Proteome, Exosomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Tobias Moeller-BertramIndustry (pharma, biotech, devices)
- Collaborators
- Metamorphosis, LLC, University of California, San Diego
- Study start
- 23 Mar 2022 (actual)
- Primary completion
- 6 May 2023 (actual)
- Study completion
- 6 May 2023 (actual)
- First posted
- 26 Sep 2024 (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.
This study will be focused on assessing the molecular, physiological, neuroimaging, and emotional correlates of a week-long intensive meditation retreat experience in a 20-person cohort comprised of healthy participants.
Detailed description
Mind-body interventions including meditation, reconceptualization, and placebo have been shown to improve a broad range of physical and mental health outcomes in both healthy and patient populations. How and what humans think about their health has a significant and quantifiable impact.
Placebo effects, another mind-body technique that creates health improvements, have been shown to impact every major organ system. More recently, open-label placebos, placebos administered without concealment such that the subject is aware of the placebo, have been shown to be effective for a host of health conditions. Open-label placebo effects demonstrate that placebo responses are surprisingly not dependent on deception, positive expectation, or conditioning.
Meditation, yet another mind-body intervention, has been shown to reduce pain, inflammation, stress, anxiety, depression, and to improve immune function, and emotional regulation. Different meditation techniques can produce mystical-type experiences-non-ordinary perceptual, cognitive, and affective states in which the distinction between the perceiver and the perceived is transcended. The specific pathways through which meditation promotes physical and mental health are not yet well understood, but meditation-induced changes in neural activity and on the immune and autonomic nervous systems, as well as meditation-induced molecular changes in gene expression and on the proteome and metabolome suggest that these are both broad and profound.
While each of these mind-body interventions has been studied individually, the combination of meditation, reconceptualization, and open label placebo and their combined effect on health, neural activity, and molecular physiology have never been jointly studied. This exploratory observational study will employ psychometric health questionnaires; functional magnetic resonance imaging (fMRI); quantitative electroencephalography (qEEG); and blood plasma-based real time cell metabolic analysis, quantitative assessment of neurite outgrowth, and high-throughput transcriptomics, proteomics, and metabolomics to investigate the joint neural and biological effects of these three mind-body interventions in a 7-day retreat setting.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group study | – | Behavioral: Advanced multi-component meditation practiceDr Joe Dispenza Week Long Advanced Retreat Attendees |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All study participants are registered for the advanced meditation retreat.
Key inclusion criteria (10 listed)
- Must be 21 years of age or older
- Must speak English
- Must be a registered attendee of the advanced week-long meditation retreat
- Must be in generally good health
- Must agree to provide blood and buccal samples before and after the retreat
Key exclusion criteria (10 listed)
- Younger than 21 years of age
- Non-English speaking
- Not a registered attendee of the advanced week-long meditation retreat
- Not willing to complete the research consent
- Has a serious health condition
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 |
|---|---|---|
| Advanced multi-component meditation practiceThe study intervention is a multi-component advanced guided meditation practice that incorporates elements of focused attention, non-dual, and loving kindness and compassion meditation techniques as well as breathwork components. The practice includes sitting, lying down, standing, and walking components and is carried out at 7-day advanced meditation retreats lead by Joe Dispenza, D.C. These retreats include lecture-based instruction and up to 35 hours of meditation practice. | Behavioural | Single group study |
Primary outcome
Functional brain changes as monitored by functional magnetic resonance imaging (fMRI) following an intensive week-long meditation retreat
Time frame: 1 week
fMRI scans will be taken on subjects during two conditions (rest and a 15-minute meditation) before and after the week-long retreat to assess changes in brain functional connectivity associated with meditation (meditation vs rest) and resulting from the retreat (pre vs post). It is expected that whole-brain functional connectivity will become more integrated during meditation as well as after the week-long retreat. Resting state network connectivity will be assessed, and it is expected that default mode network (DMN) intra-network connectivity will decrease during meditation and more so post-retreat.
Mystical Experience Questionnaire (MEQ)-30 scores before and after an intensive week-long meditation retreat
Time frame: 1 week
Subjects will be given the MEQ-30 survey following a 15-minute scanner meditation before and after the retreat. An increase in MEQ-30 score is indicative of a higher shift in consciousness and presumably to a more favorable psychological state. Scores will be correlated to functional brain changes.
Brain activity changes as assessed by quantitative EEQ (qEEG) before and after an intensive week-long meditation retreat.
Time frame: 1 week
Brain scans will be collected by qEEG on all subjects during a 15-minute meditation before and after the retreat to assess brain complexity. It is expected that brain complexity will increase after the week-long retreat.
Blood plasma proteomic and metabolomic analysis before and after an intensive week-long meditation retreat.
Time frame: 1 week
An integrative analysis of proteomic and metabolomic expression in blood plasma will be carried out in samples collected before and after the retreat. The expectation is that shifts in biological processes toward an improved state of health will occur after the week-long retreat.
2 secondary outcomes
Heart rate variability changes during a week-long meditation retreat
Time frame: 1 week
Effect of meditation-conditioned blood on neurite outgrowth
Time frame: 1 week
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 10 Oct 2024.
- Background: PubMed 21471390Zeidan F, Martucci KT, Kraft RA, Gordon NS, McHaffie JG, Coghill RC. Brain mechanisms supporting the modulation of pain by mindfulness meditation. J Neurosci. 2011 Apr 6;31(14):5540-8. doi: 10.1523/JNEUROSCI.5791-10.2011.
- Background: PubMed 32066726Ng TKS, Fam J, Feng L, Cheah IK, Tan CT, Nur F, Wee ST, Goh LG, Chow WL, Ho RC, Kua EH, Larbi A, Mahendran R. Mindfulness improves inflammatory biomarker levels in older adults with mild cognitive impairment: a randomized controlled trial. Transl Psychiatry. 2020 Jan 21;10(1):21. doi: 10.1038/s41398-020-0696-y.
- Background: PubMed 27998508Khoury B, Knauper B, Schlosser M, Carriere K, Chiesa A. Effectiveness of traditional meditation retreats: A systematic review and meta-analysis. J Psychosom Res. 2017 Jan;92:16-25. doi: 10.1016/j.jpsychores.2016.11.006. Epub 2016 Nov 18.
- BackgroundOyler, D. L. et al. The Influence of Meditative Interventions on Immune Functioning: A Meta-Analysis. Mindfulness 14, 1815-1851 (2023).
- Background: PubMed 26002763de Castro JM. Meditation has stronger relationships with mindfulness, kundalini, and mystical experiences than yoga or prayer. Conscious Cogn. 2015 Sep;35:115-27. doi: 10.1016/j.concog.2015.04.022. Epub 2015 May 22.
- Background: PubMed 32114450Afonso RF, Kraft I, Aratanha MA, Kozasa EH. Neural correlates of meditation: a review of structural and functional MRI studies. Front Biosci (Schol Ed). 2020 Mar 1;12(1):92-115. doi: 10.2741/S542.
- Background: PubMed 19451642Tang YY, Ma Y, Fan Y, Feng H, Wang J, Feng S, Lu Q, Hu B, Lin Y, Li J, Zhang Y, Wang Y, Zhou L, Fan M. Central and autonomic nervous system interaction is altered by short-term meditation. Proc Natl Acad Sci U S A. 2009 Jun 2;106(22):8865-70. doi: 10.1073/pnas.0904031106. Epub 2009 May 18.
- Background: PubMed 28670311Buric I, Farias M, Jong J, Mee C, Brazil IA. What Is the Molecular Signature of Mind-Body Interventions? A Systematic Review of Gene Expression Changes Induced by Meditation and Related Practices. Front Immunol. 2017 Jun 16;8:670. doi: 10.3389/fimmu.2017.00670. eCollection 2017.
- Background: PubMed 35576643Xue T, Chiao B, Xu T, Li H, Shi K, Cheng Y, Shi Y, Guo X, Tong S, Guo M, Chew SH, Ebstein RP, Cui D. The heart-brain axis: A proteomics study of meditation on the cardiovascular system of Tibetan Monks. EBioMedicine. 2022 Jun;80:104026. doi: 10.1016/j.ebiom.2022.104026. Epub 2022 May 13.
- BackgroundChen, W. et al. Comprehensive Metabolomic and Lipidomic Analysis Reveals Metabolic Changes After Mindfulness Training. Mindfulness 11, 1390-1400 (2020).
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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.
Tobias Moeller-Bertram, MD principal investigator
VitaMed Research LLC
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 Intensive Meditation in Novice and Experienced Meditators, run by Tobias Moeller-Bertram 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 10 inclusion and 10 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 10 Oct 2024. 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?
Functional brain changes as monitored by functional magnetic resonance imaging (fMRI) following an intensive week-long meditation retreat (time frame: 1 week). The study lists 4 primary outcomes in all. 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 NCT06615531, which also lists 10 linked publications.
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 10 Oct 2024.