Healthy SubjectsNCT03221374

Mind-body Awareness Training and Brain-computer Interface

A study testing Mindfulness Based Stress Reduction in people with Healthy Subjects, run by Carnegie Mellon University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Subjects
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: 231 participants
Where: 1 siteUnited States
Study dates: 1 Sep 2016to 31 May 2023
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 64 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Apparently healthy volunteers
Age 18-64, inclusive.
Willing and able to provide written consent.
Able to communicate in the English language.

Who cannot join

Any past BCI experience.
Pregnancy
Any breathing, movement, or visual disorders.
Any active neurological or mental disorders.
History of epilepsy.
History of a vascular or cardiac disorder (e.g. heart disease)

Show all 40Show fewer

History of a metabolic disorder (e.g. diabetes)
Any other condition which would make the subject, in the opinion of the investigator, unsuitable for the study.
Exclusion criteria that would prevent subjects from participating in the optional MRI component will be:
Any MRI incompatible indwelling metal objects or implantable devices, including but not limited to the following (dental mental is allowable):
Cardiac pacemaker
Implanted cardiac defibrillator
Carotid artery vascular clamp
Intravascular stents, filters, or coils
Aortic clip
Internal pacing wires
Vascular access port and/or catheter
Swan-Ganz catheter
Shunt (spinal or intraventricular)
Aneurysm clip(s)
Neurostimulator
Electrodes (on body, head, or brain)
Heart valve prosthesis
Any type of prosthesis (eye, penile, etc.)
Artificial limb or joint replacement
Bone growth/fusion stimulator
Bone/joint pin, screw, nail, wire, plate
Metal rods in bones
Harrington rods (spine)
Metal or wire mesh implants
Wire sutures or surgical staples
Insulin pump or infusion device
Any metal fragments (i.e. metal shop)
Any implant held in place by a magnet
Cochlear, otologic, or ear implant
Claustrophobia
Hearing aid use
Any yoga/meditation in the last three months.
More than 12 yoga/meditation classes in the last 12 months.
Approximately weekly yoga/meditation for a year or more at any point in the past.

Trial locations and contacts

1 site in 1 country.

United States1 site

Biomedical Engineering Department Carnegie Mellon University
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

Mind-Body Awareness Training (MBAT), in the forms of various yoga and meditative practices, has become increasingly prevalent due to an increase in awareness of the potential health benefits, and improvements in concentration that this training can provide to practitioners. In the present study, the role of Mind-Body Awareness Training (MBAT) in the initial learning of a sensorimotor (SMR) based Brain-Computer Interface (BCI) is being investigated. The hypothesis is that MBAT will improve performance in SMR based BCI.

Read the detailed description

In this protocol, the following hypothesis will be tested; namely that MBAT including the verified mindfulness based stress reduction (MBSR) course will improve the ability for subjects to concentrate on the control of the SMR thus improving the performance of BCI. Subjects will be recruited for short term MBAT and then undergo BCI training. The performance of subjects with MBAT will be compared with those without MBAT to test the hypothesis. Procedures involved include a standard 8-week MBSR course, and an EEG brain noninvasive brain computer interface study.

Conditions: Healthy Subjects
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
8-week mindfulness based stress reduction course intended to develop mind-body awareness through mindfulness practices.

Study groups in NCT03221374
Study group	Role	What they receive
Mindfulness Based Stress Reduction	Experimental	Participants will attend an 8-week Mindfulness Based Stress Reduction (MBSR) course between pre- and post-testing. Receives: Behavioral: Mindfulness Based Stress Reduction
Waitlist	No intervention	Participants will be added to a waitlist intervention group for 8-weeks between pre-and post-testing.

What is being measured

The primary outcome is the main question the study is designed to answer.

BCI Performance Change From Baseline
This outcome is related to the sub-study to investigate the effect of the MBSR on BCI learning. During the course of the sub-study over approximately 6 months/cohort of participants, participant learning over time during the course of study will be examined in terms of performance change after the intervention as well as across sessions, with a positive number representing an increase, and a negative number to represent a decrease. The percent valid correct (percent correct over valid trials) metric will be used to evaluate learning.
Measured: 6 months for each participant.
Breath Counting Task
This outcome is related to the sub-study to investigate the effect of the MBSR on BCI learning. The breath-counting task will be used to measure the participants' mindfulness. Specifically, participants will be asked to count their breaths in cycles of nine (inhale and exhale counting as one) for 18 minutes, pressing one button for the first eight breaths, and a second button for the ninth. Breath counting accuracy is quantified as the number of correctly labeled breath cycles divided by the total number of cycles. The breath-counting accuracy for pre and post-intervention will be used.
Measured: 6 months for each participant.
Survey Results and Correlation With BCI Performance
In the first session, participants are asked to complete two surveys to measure one's level of mindfulness before the BCI experiment. In both surveys, a higher score indicates a higher level of mindfulness:
Survey 1: The Freiburg Mindfulness Inventory (FMI), with 14 statements, such as "I am open to the experience of the present moment". Participants are asked to use a 1-4 scale to indicate how often they have such an experience. The FMI score is calculated by summing up the answers to each question with a proper re-code of one question. FMI score range (minimum to maximum): 14 to 56.
Survey 2: Day-to-Day Experiences, with 15 questions, such as "I find it difficult to stay focused on what's happening in the present". Participants are asked to use a 1-6 scale to indicate how often they have such an experience. The Mindful Attention Awareness Scale (MAAS) is calculated by averaging answers to each question in this survey. MAAS score range (minimum to maximum): 1 to 6.
Measured: During the first experiment session, when each participant did the screening

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 201631 May 2023

First posted18 Jul 2017
Study start1 Sep 2016
Primary completion31 May 2023
Study completion31 May 2023

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 Healthy SubjectsStudies 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: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 231 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03221374
Sponsor's protocol ID: R01AT009263-01
Status last verified: Jul 2024
First submitted: 7 Jul 2017
Last updated: 7 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
Mood Disorders, Anxiety Disorders
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
RecruitingPhase 1
A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
Healthy Adult
RecruitingObservational study
Collection of Lung Fluid and Tissue Samples for Research
Leukocyte Disorders, Respiratory Tract Diseases
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy

All Healthy Subjects trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mind-body Awareness Training and Brain-computer Interface
ClinicalTrials.gov ID: NCT03221374
Acronym / sponsor ID: R01AT009263-01
Conditions: Healthy Subjects
Study type: Interventional
Recruitment status: Completed
Enrolment: 231 participants (actual)
Lead sponsor: Carnegie Mellon UniversityUniversity, hospital or other
Study start: 1 Sep 2016 (actual)
Primary completion: 31 May 2023 (actual)
Study completion: 31 May 2023 (actual)
First posted: 18 Jul 2017 (actual)
Results: Posted 7 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Mindfulness Based Stress Reduction	Experimental	Behavioral: Mindfulness Based Stress ReductionParticipants will attend an 8-week Mindfulness Based Stress Reduction (MBSR) course between pre- and post-testing.
Waitlist	No intervention	–Participants will be added to a waitlist intervention group for 8-weeks between pre-and post-testing.

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Apparently healthy volunteers
Age 18-64, inclusive.
Willing and able to provide written consent.
Able to communicate in the English language.

Key exclusion criteria (40 listed)

Any past BCI experience.
Pregnancy
Any breathing, movement, or visual disorders.
Any active neurological or mental disorders.
History of epilepsy.

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 Reduction8-week mindfulness based stress reduction course intended to develop mind-body awareness through mindfulness practices.	Behavioural	Mindfulness Based Stress Reduction

Primary outcome

BCI Performance Change From Baseline
Time frame: 6 months for each participant.
This outcome is related to the sub-study to investigate the effect of the MBSR on BCI learning. During the course of the sub-study over approximately 6 months/cohort of participants, participant learning over time during the course of study will be examined in terms of performance change after the intervention as well as across sessions, with a positive number representing an increase, and a negative number to represent a decrease. The percent valid correct (percent correct over valid trials) metric will be used to evaluate learning.
Breath Counting Task
Time frame: 6 months for each participant.
This outcome is related to the sub-study to investigate the effect of the MBSR on BCI learning. The breath-counting task will be used to measure the participants' mindfulness. Specifically, participants will be asked to count their breaths in cycles of nine (inhale and exhale counting as one) for 18 minutes, pressing one button for the first eight breaths, and a second button for the ninth. Breath counting accuracy is quantified as the number of correctly labeled breath cycles divided by the total number of cycles. The breath-counting accuracy for pre and post-intervention will be used.
Survey Results and Correlation With BCI Performance
Time frame: During the first experiment session, when each participant did the screening
In the first session, participants are asked to complete two surveys to measure one's level of mindfulness before the BCI experiment. In both surveys, a higher score indicates a higher level of mindfulness: Survey 1: The Freiburg Mindfulness Inventory (FMI), with 14 statements, such as "I am open to the experience of the present moment". Participants are asked to use a 1-4 scale to indicate how often they have such an experience. The FMI score is calculated by summing up the answers to each question with a proper re-code of one question. FMI score range (minimum to maximum): 14 to 56. Survey 2: Day-to-Day Experiences, with 15 questions, such as "I find it difficult to stay focused on what's happening in the present". Participants are asked to use a 1-6 scale to indicate how often they have such an experience. The Mindful Attention Awareness Scale (MAAS) is calculated by averaging answers to each question in this survey. MAAS score range (minimum to maximum): 1 to 6.

Results and safety

Results posted to the registry on 7 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mindfulness Based Stress Reduction - UMN	72	42
Waitlist - UMN	72	34
Experienced Meditator - CMU	32	22
Meditation Naive - CMU	34	26
Mindfulness Based Stress Reduction - CMU	8	7
Waitlist - CMU	8	5
Short Term Meditation - CMU - Meditation	3	2
Short Term Meditation - CMU - Control	2	1

Primary outcome: BCI Performance Change From Baseline

Time frame: 6 months for each participant.. Mean (Standard Deviation). Unit: Percent valid correct (PVC)

Measure	Mindfulness Based Stress Reduction - UMN n = 33	Waitlist - UMN n = 29
Value	16.87 (14.55)	7.9 (15.96)

Mindfulness Based Stress Reduction - UMN vs Waitlist - UMN: p = 0.003, Mixed Models Analysis
Mindfulness Based Stress Reduction - UMN vs Waitlist - UMN: Mean Difference (Net): 8.98, p = 0.024, t-test, 2 sided

Population analysed: The population consists of participants recruited in the UMN site to investigate the effect of 8-week MBSR class on the effect of BCI learning. During the analysis, participants were excluded if they dropped the experiment, did not follow the task guideline, or exhibited ceiling performance. The number of participants in the "Mindfulness-Based Stress Reduction - CMU", "Waitlist - CMU" are too small to draw statistical conclusions and thus were not included.

Primary outcome: Breath Counting Task

Time frame: 6 months for each participant.. Median (Inter-Quartile Range). Unit: percentage of breath counting accuracy

Measure	Mindfulness Based Stress Reduction - UMN n = 33	Waitlist - UMN n = 29
Value	93.18 (85.82 to 96.06)	77.79 (69.40 to 84.59)

Mindfulness Based Stress Reduction - UMN vs Waitlist - UMN: Mean Difference (Net): 15.40, p <0.001, Wilcoxon (Mann-Whitney)

Primary outcome: Survey Results and Correlation With BCI Performance

Time frame: During the first experiment session, when each participant did the screening. Mean (Standard Deviation). Unit: score on a scale

Measure	Experienced Meditator - CMU n = 14	Meditation Naive - CMU n = 15
FMI score	44.5 (4.5)	36.6 (6.7)
MAAS score	4.42 (0.81)	3.73 (0.67)

Experienced Meditator - CMU vs Meditation Naive - CMU: Mean Difference (Final Values): 7.9, p <0.01, Wilcoxon (Mann-Whitney)
Experienced Meditator - CMU vs Meditation Naive - CMU: Mean Difference (Final Values): 0.69, p <0.05, Wilcoxon (Mann-Whitney)
Experienced Meditator - CMU vs Meditation Naive - CMU: correlation coefficient: 0.42, p <0.05, Regression, Linear

Population analysed: The population consists of experienced meditators and meditation naive controls. During the analysis, outliers whose BCI performance were outside the ± 2.5 median absolute deviations from the median of the whole sample were excluded.

Adverse events

Time frame: Between when participants were enrolled and completed the last experiment. The period is about 6 months for the sub-study to investigate the effect of MBSR on BCI learning, 1~2 months for the sub-study to investigate the BCI learning of experienced meditators, and 2~3 weeks for the sub-study to examine the effect of short-term meditation on BCI learning.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mindfulness Based Stress Reduction - UMN	0 of 72 (0%)	0 of 72 (0%)	0 of 72
Waitlist - UMN	0 of 72 (0%)	0 of 72 (0%)	0 of 72
Experienced Meditator - CMU	0 of 32 (0%)	0 of 32 (0%)	0 of 32
Meditation Naive - CMU	0 of 34 (0%)	0 of 34 (0%)	0 of 34
Mindfulness Based Stress Reduction - CMU	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Waitlist - CMU	0 of 8 (0%)	0 of 8 (0%)	0 of 8
Short Term Meditation - CMU - Meditation	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Short Term Meditation - CMU - Control	0 of 2 (0%)	0 of 2 (0%)	0 of 2

Limitations and caveats (from the sponsor): Limitations of the MBSR brain-computer interface sub-study design: 1. The lack of an active control group that requires the same mental commitment of time or intensity as a meditation practice. 2. The exclusive use of the breath counting task as our sole measure of mindfulness. Limitation of the experienced meditation sub-study design: Due to the limited sample size, we were unable to determine if the difference in age and sex between groups were significantly influencing the results.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Healthy Subjects

RecruitingObservational study
Development of Magnetic Resonance Imaging Techniques for Studying Mood and Anxiety Disorders
Mood Disorders, Anxiety Disorders
Not yet recruiting
Positron Emission Tomography and Organ-Specific Changes in Participants Co-Enrolled in NIH Studies of Plasmodium Vivax Controlled Human Malaria Infection
Healthy Volunteer, Malaria
RecruitingPhase 1
A Single Ascending Dose Study of DTI-117 Given Intramuscularly in Healthy Participants.
Healthy Adult
RecruitingObservational study
Collection of Lung Fluid and Tissue Samples for Research
Leukocyte Disorders, Respiratory Tract Diseases
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy

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.

Bin He, Ph.D principal investigator

Carnegie Mellon 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 Mindfulness Based Stress Reduction in people with Healthy Subjects, run by Carnegie Mellon University 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 4 inclusion and 40 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 7 Aug 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?

Yes. Results are posted in the registry (first posted 7 Aug 2024). 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?

BCI Performance Change From Baseline (time frame: 6 months for each participant.). 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?

On the ClinicalTrials.gov record for NCT03221374.

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 7 Aug 2024.