MeditationNCT05020301
Investigation of Functional Brain Network in Altered Meditation State With Multimodal Neuroimaging
A study testing external meditation guided audio and internal meditation guided audio in people with Meditation and Mindfulness, run by Shanghai Mental Health Center at 1 site in China.
Trial summary
The purpose of this study is to investigate functional brain network in altered meditation state with multimodal neuroimaging. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Meditation, Mindfulness
- What is being tested?
- external meditation guided audio and internal meditation guided audio
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2020to 30 Dec 2023
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- A sufficient level of education to understand study procedure and be able to communicate with site personnel.
- 18-60 years old.
- Interested in meditation.
- No metal or electronic implants in the body; no prosthesis (metal braces, dentures, etc.); no claustrophobia; no tattoos, piercings, etc.; no makeup on the day of the experiment.
- Right-handed.
Who cannot join
- The participant has a contraindication to MRI examination, such as claustrophobia.
- The participant is physically unfit for MRI, such as having a metal implant.
- The participant has a history of neurological or psychiatric disorders, or is taking any chronic medications that may interfere with the experiment.
Trial locations and contacts
1 site in 1 country.
China1 site
School of Biomedical Engineering, Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200030
About this study
The purpose of this study is to investigate functional brain network in altered meditation state with multimodal neuroimaging.
Read the detailed description
- Recruiting participants by approaching mindfulness training, poster, and websites.
- Completing Questionnaires, Tests, and other materials for experiments.
- Examining Functional Brain Network of Internal and External Meditation of practitioners with a meditation using multimodal neuroimaging.
- Collecting and evaluating data about the connection of internal and external meditation with multimodal neuroimaging and identifying the function related to meditation state.
- Conditions
- Meditation, Mindfulness
- Being tested
- external meditation guided audio, internal meditation guided audio
- Keywords
- mindfulness, functional brain network, neuroimaging, meditation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
external meditation guided audioDevice
Examining DMN connectivity and CSF flow in external meditation state by External Meditation Instruction Audio.
internal meditation guided audioDevice
Examining DMN connectivity and CSF flow in external meditation state by Internal Meditation Instruction Audio.
| Study group | Role | What they receive |
|---|---|---|
| Novice meditators | Experimental | Participants who have no meditation practice in the previous year and less than 20 entire lifetime hours' meditation. Receives: Device: external meditation guided audio; Device: internal meditation guided audio |
| Experienced meditators | Experimental | Participants with more than two years of mindfulness practice Receives: Device: external meditation guided audio; Device: internal meditation guided audio |
What is being measured
The primary outcome is the main question the study is designed to answer.
Five Facet Mindfulness Questionnaire(FFMQ)
FFMQ is a validated, self-administered questionnaire that measures the tendency to act with mindfulness. Its 39 items are assessed on a Likert scale from 1 to 5 (i.e., "never or very rarely true" to "very often or always true"). The higher scores on the scale convey the higher tendency to act with mindfulness.
Measured: Week 1
CSF pulsation index
CSF pulsation index, calculated by the number of CSF pulsation per minute.
Measured: Week 1
Functional connectivity
Checking functional connectivity in major resting-state brain networks (such as DMN).
Measured: Week 1
Secondary outcomes (5)
Mindfulness positive awareness examined by Mindful Attention Awareness Scale (MAAS)
MAAS is a validated, fifteen-item self-report measure on which the items are scored using a six-point rating scale (1 = almost always and 6 = almost never). The global score of the scale is obtained by calculating the mean score of each participant's responses, and higher scores on the scale convey the higher levels of dispositional mindfulness.
Measured: Week 1
The ability of self-compassion examined by Self-Compassion Scale(SCS) after 1-week practice of internal and external mindfulness
SCS is a validated, 26-item self-report measure on which the items are scored using a five-point Likert scale scored from 1 (almost never) to 5 (almost always). The higher total score on the scale indicates a higher level of self-compassion.
Measured: Week 1
Cognitive Flexibility Inventory(CFI)
CFI is a validated, self-reported measure of cognitive flexibility，which consists of 20 statements scored from 1 ( "definitely disagree") to 7( "definitely agree."). The scores for all items are pooled to generate a total score of 20 to 140. Higher total scores indicate the increasing level of cognitive flexibility.
Measured: Week 1
Perceived Stress Scale(PSS)
PSS is a validated, self-reported measure of psychological stress level. There are 10-items scored from 0 (never) to 4 (very often). The scores for all items are pooled to generate a total score in the range of 0 to 40. Higher total scores indicate the increasing level of psychological stress.
Measured: Week 1
The Chinese version of Freiburg Mindfulness Inventory(FMI-13)
FMI-13 is a validated, thirteen-item self-report measure on which the items are scored using a four-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree). This short form was used for measuring mindfulness traits, and higher scores on the scale convey the higher levels of mindfulness trait.
Measured: Week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start20 Sep 2020
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MeditationStudies of the same condition, open and under way.
- More trials run by Shanghai Mental Health CenterThe 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Mental Health Center
- Sponsor type
- University, hospital or other
- Collaborators
- School of Biomedical Engineering, Shanghai Jiao Tong University
- Responsible party
- Sponsor
- Investigators
- Qing Fan, Study chair, Shanghai Mental Health CenterJie Luo, Study chair, School of Biomedical Engineering, Shanghai Jiao Tong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05020301
- Sponsor's protocol ID
- B20200361
- Status last verified
- Jun 2021
- First submitted
- 14 Jul 2021
- Last updated
- 23 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Functional Brain Network in Altered Meditation State With Multimodal Neuroimaging
- ClinicalTrials.gov ID
- NCT05020301
- Acronym / sponsor ID
- B20200361
- Conditions
- Meditation, Mindfulness
- Keywords
- mindfulness, functional brain network, neuroimaging, meditation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Shanghai Mental Health CenterUniversity, hospital or other
- Collaborators
- School of Biomedical Engineering, Shanghai Jiao Tong University
- Study start
- 20 Sep 2020 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 25 Aug 2021 (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.
The purpose of this study is to investigate functional brain network in altered meditation state with multimodal neuroimaging.
Detailed description
- Recruiting participants by approaching mindfulness training, poster, and websites.
- Completing Questionnaires, Tests, and other materials for experiments.
- Examining Functional Brain Network of Internal and External Meditation of practitioners with a meditation using multimodal neuroimaging.
- Collecting and evaluating data about the connection of internal and external meditation with multimodal neuroimaging and identifying the function related to meditation state.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novice meditators | Experimental | Device: external meditation guided audio, Device: internal meditation guided audioParticipants who have no meditation practice in the previous year and less than 20 entire lifetime hours' meditation. |
| Experienced meditators | Experimental | Device: external meditation guided audio, Device: internal meditation guided audioParticipants with more than two years of mindfulness practice |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- A sufficient level of education to understand study procedure and be able to communicate with site personnel.
- 18-60 years old.
- Interested in meditation.
- No metal or electronic implants in the body; no prosthesis (metal braces, dentures, etc.); no claustrophobia; no tattoos, piercings, etc.; no makeup on the day of the experiment.
- Right-handed.
Key exclusion criteria (3 listed)
- The participant has a contraindication to MRI examination, such as claustrophobia.
- The participant is physically unfit for MRI, such as having a metal implant.
- The participant has a history of neurological or psychiatric disorders, or is taking any chronic medications that may interfere with the experiment.
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 |
|---|---|---|
| external meditation guided audioExamining DMN connectivity and CSF flow in external meditation state by External Meditation Instruction Audio. | Device | Experienced meditators, Novice meditators |
| internal meditation guided audioExamining DMN connectivity and CSF flow in external meditation state by Internal Meditation Instruction Audio. | Device | Experienced meditators, Novice meditators |
Primary outcome
Five Facet Mindfulness Questionnaire(FFMQ)
Time frame: Week 1
FFMQ is a validated, self-administered questionnaire that measures the tendency to act with mindfulness. Its 39 items are assessed on a Likert scale from 1 to 5 (i.e., "never or very rarely true" to "very often or always true"). The higher scores on the scale convey the higher tendency to act with mindfulness.
CSF pulsation index
Time frame: Week 1
CSF pulsation index, calculated by the number of CSF pulsation per minute.
Functional connectivity
Time frame: Week 1
Checking functional connectivity in major resting-state brain networks (such as DMN).
5 secondary outcomes
Mindfulness positive awareness examined by Mindful Attention Awareness Scale (MAAS)
Time frame: Week 1
The ability of self-compassion examined by Self-Compassion Scale(SCS) after 1-week practice of internal and external mindfulness
Time frame: Week 1
Cognitive Flexibility Inventory(CFI)
Time frame: Week 1
Perceived Stress Scale(PSS)
Time frame: Week 1
The Chinese version of Freiburg Mindfulness Inventory(FMI-13)
Time frame: Week 1
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 23 Jul 2026.
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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.
Qing Fan study chair
Shanghai Mental Health Center
Jie Luo study chair
School of Biomedical Engineering, Shanghai Jiao Tong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing external meditation guided audio and internal meditation guided audio in people with Meditation and Mindfulness, run by Shanghai Mental Health Center at 1 site in China.
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 5 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 23 Jul 2026. 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 China. 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?
Five Facet Mindfulness Questionnaire(FFMQ) (time frame: Week 1). The study lists 3 primary outcomes in all. 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 23 Jul 2026.