Trial Outcomes & Findings for Mind-body Awareness Training and Brain-computer Interface (NCT NCT03221374)

Last Updated: 2024-08-07

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

231 participants

Primary outcome timeframe

6 months for each participant.

Results posted on

2024-08-07

Participant Flow

Subjects were recruited by flyers posted around the campus, references by the meditator instructors, or department emails.

Subjects will be excluded, if they tell the experimenter that they do not wish to continue the participation.

Participant milestones

Participant milestones
Measure	Mindfulness Based Stress Reduction - UMN Participants will attend an 8-week Mindfulness Based Stress Reduction (MBSR) course between pre- and post-testing. This cohort of experiment was performed at the University of Minnesota (UMN). Mindfulness Based Stress Reduction: 8-week mindfulness based stress reduction course intended to develop mind-body awareness through mindfulness practices.	Waitlist - UMN Participants will be added to a waitlist intervention group for 8-weeks between pre-and post-testing. This cohort of experiment was performed at the University of Minnesota (UMN).	Experienced Meditator - CMU Participants that have more than 1 year of regular meditation experience, and will perform a series of brain-computer interface experiments.	Meditation Naive - CMU Participants that have no regular meditation experience, and will perform a series of brain-computer interface experiments.	Mindfulness Based Stress Reduction - CMU Participants will attend an 8-week Mindfulness Based Stress Reduction (MBSR) course between pre- and post-testing. This cohort of experiment was performed at the Carnegie Mellon University (CMU). Mindfulness Based Stress Reduction: 8-week mindfulness based stress reduction course intended to develop mind-body awareness through mindfulness practices.	Waitlist - CMU Participants will be added to a waitlist intervention group for 8-weeks between pre-and post-testing. This cohort of experiment was performed at the Carnegie Mellon University (CMU).	Short Term Meditation - CMU - Meditation Participants will undergo a 20-minute meditation between two Brain-computer interface sessions.	Short Term Meditation - CMU - Control Participants will listen to a 20-min reading of meditation related journal article between two Brain-computer interface sessions.
Overall Study STARTED	72	72	32	34	8	8	3	2
Overall Study COMPLETED	42	34	22	26	7	5	2	1
Overall Study NOT COMPLETED	30	38	10	8	1	3	1	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mind-body Awareness Training and Brain-computer Interface

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Mindfulness Based Stress Reduction - UMN n=72 Participants Participants will attend an 8-week Mindfulness Based Stress Reduction (MBSR) course between pre- and post-testing. Mindfulness Based Stress Reduction: 8-week mindfulness based stress reduction course intended to develop mind-body awareness through mindfulness practices.	Waitlist - UMN n=72 Participants Participants will be added to a waitlist intervention group for 8-weeks between pre-and post-testing.	Experienced Meditator - CMU n=32 Participants participants that have more than 1 year of regular meditation experience	Meditation Naive - CMU n=34 Participants Participants that have no regular meditation experience	Mindfulness Based Stress Reduction - CMU n=8 Participants Participants will attend an 8-week Mindfulness Based Stress Reduction (MBSR) course between pre- and post-testing. Mindfulness Based Stress Reduction: 8-week mindfulness based stress reduction course intended to develop mind-body awareness through mindfulness practices.	Waitlist - CMU n=8 Participants Participants will be added to a waitlist intervention group for 8-weeks between pre-and post-testing.	Short Term Meditation - CMU - Meditation n=3 Participants Participants will undergo a 20-minute meditation between two Brain-computer interface sessions.	Short Term Meditation - CMU - Control n=2 Participants Participants will listen to a 20-min reading of meditation related journal aritcle between two Brain-computer interface sessions.	Total n=231 Participants Total of all reporting groups
Age, Continuous	38.2 years STANDARD_DEVIATION 14.6 • n=5 Participants	34.1 years STANDARD_DEVIATION 13.3 • n=7 Participants	41.6 years STANDARD_DEVIATION 16.5 • n=5 Participants	26.5 years STANDARD_DEVIATION 9.3 • n=4 Participants	32.3 years STANDARD_DEVIATION 15.4 • n=21 Participants	26.8 years STANDARD_DEVIATION 8.0 • n=10 Participants	45.7 years STANDARD_DEVIATION 19.3 • n=115 Participants	39.5 years STANDARD_DEVIATION 4.9 • n=6 Participants	35.2 years STANDARD_DEVIATION 14.4 • n=6 Participants
Sex: Female, Male Female	56 Participants n=5 Participants	59 Participants n=7 Participants	17 Participants n=5 Participants	23 Participants n=4 Participants	5 Participants n=21 Participants	2 Participants n=10 Participants	2 Participants n=115 Participants	0 Participants n=6 Participants	164 Participants n=6 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	13 Participants n=7 Participants	15 Participants n=5 Participants	11 Participants n=4 Participants	3 Participants n=21 Participants	6 Participants n=10 Participants	1 Participants n=115 Participants	2 Participants n=6 Participants	67 Participants n=6 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	6 Participants n=6 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	63 Participants n=5 Participants	63 Participants n=7 Participants	30 Participants n=5 Participants	30 Participants n=4 Participants	7 Participants n=21 Participants	8 Participants n=10 Participants	3 Participants n=115 Participants	2 Participants n=6 Participants	206 Participants n=6 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	8 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	19 Participants n=6 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	7 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants	0 Participants n=21 Participants	6 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	24 Participants n=6 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=6 Participants	12 Participants n=6 Participants
Race (NIH/OMB) White	57 Participants n=5 Participants	56 Participants n=7 Participants	24 Participants n=5 Participants	21 Participants n=4 Participants	6 Participants n=21 Participants	0 Participants n=10 Participants	3 Participants n=115 Participants	1 Participants n=6 Participants	168 Participants n=6 Participants
Race (NIH/OMB) More than one race	7 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	10 Participants n=6 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	6 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	17 Participants n=6 Participants
Prior regular meditation experience over 1 year	0 Participants n=5 Participants	0 Participants n=7 Participants	32 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	1 Participants n=115 Participants	0 Participants n=6 Participants	33 Participants n=6 Participants

PRIMARY outcome

Timeframe: 6 months for each participant.

Population: 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.

Outcome measures

Outcome measures
Measure	Mindfulness Based Stress Reduction - UMN n=33 Participants Participants will attend an 8-week Mindfulness Based Stress Reduction (MBSR) course between pre- and post-testing. This cohort of experiment was performed at the Carnegie Mellon University (CMU). Mindfulness Based Stress Reduction: 8-week mindfulness based stress reduction course intended to develop mind-body awareness through mindfulness practices.	Waitlist - UMN n=29 Participants Participants will be added to a waitlist intervention group for 8-weeks between pre-and post-testing. This cohort of experiment was performed at the Carnegie Mellon University (CMU).
BCI Performance Change From Baseline	16.87 Percent valid correct (PVC) Standard Deviation 14.55	7.9 Percent valid correct (PVC) Standard Deviation 15.96

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Mindfulness Based Stress Reduction - UMN n=33 Participants Participants will attend an 8-week Mindfulness Based Stress Reduction (MBSR) course between pre- and post-testing. This cohort of experiment was performed at the Carnegie Mellon University (CMU). Mindfulness Based Stress Reduction: 8-week mindfulness based stress reduction course intended to develop mind-body awareness through mindfulness practices.	Waitlist - UMN n=29 Participants Participants will be added to a waitlist intervention group for 8-weeks between pre-and post-testing. This cohort of experiment was performed at the Carnegie Mellon University (CMU).
Breath Counting Task	93.18 percentage of breath counting accuracy Interval 85.82 to 96.06	77.79 percentage of breath counting accuracy Interval 69.4 to 84.59

PRIMARY outcome

Timeframe: During the first experiment session, when each participant did the screening

Population: 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.

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.

Outcome measures

Outcome measures
Measure	Mindfulness Based Stress Reduction - UMN n=14 Participants Participants will attend an 8-week Mindfulness Based Stress Reduction (MBSR) course between pre- and post-testing. This cohort of experiment was performed at the Carnegie Mellon University (CMU). Mindfulness Based Stress Reduction: 8-week mindfulness based stress reduction course intended to develop mind-body awareness through mindfulness practices.	Waitlist - UMN n=15 Participants Participants will be added to a waitlist intervention group for 8-weeks between pre-and post-testing. This cohort of experiment was performed at the Carnegie Mellon University (CMU).
Survey Results and Correlation With BCI Performance FMI score	44.5 score on a scale Standard Deviation 4.5	36.6 score on a scale Standard Deviation 6.7
Survey Results and Correlation With BCI Performance MAAS score	4.42 score on a scale Standard Deviation 0.81	3.73 score on a scale Standard Deviation 0.67

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Bin He

Carnegie Mellon University

Phone: 412-268-9857

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place