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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness Based Stress Reduction | Experimental | Participants 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Based Stress Reduction | Behavioral | 8-week mindfulness based stress reduction course intended to develop mind-body awareness through mindfulness practices. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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):
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.
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| Name | Affiliation | Role |
|---|---|---|
| Bin He, Ph.D | Carnegie Mellon University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biomedical Engineering Department Carnegie Mellon University | Pittsburgh | Pennsylvania | 15213 | United States |
Subjects will be excluded, if they tell the experimenter that they do not wish to continue the participation.
Subjects were recruited by flyers posted around the campus, references by the meditator instructors, or department emails.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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). |
| FG002 | Experienced Meditator - CMU | Participants that have more than 1 year of regular meditation experience, and will perform a series of brain-computer interface experiments. |
| FG003 | Meditation Naive - CMU | Participants that have no regular meditation experience, and will perform a series of brain-computer interface experiments. |
| FG004 | 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. |
| FG005 | 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). |
| FG006 | Short Term Meditation - CMU - Meditation | Participants will undergo a 20-minute meditation between two Brain-computer interface sessions. |
| FG007 | Short Term Meditation - CMU - Control | Participants will listen to a 20-min reading of meditation related journal article between two Brain-computer interface sessions. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The population described here are participants enrolled in each arm/group, which is consistent with the participants flow section.
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| ID | Title | Description |
|---|---|---|
| BG000 | Mindfulness Based Stress Reduction - UMN | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | Percent valid correct (PVC) | 6 months for each participant. |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Limitations of the MBSR brain-computer interface sub-study design:
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bin He | Carnegie Mellon University | 412-268-9857 | bhe1@andrew.cmu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 14, 2024 | Apr 22, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 29, 2024 | Jun 4, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 14, 2024 | Apr 12, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D000099024 | Mindfulness-Based Stress Reduction |
| ID | Term |
|---|---|
| D064866 | Mindfulness |
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
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| During the first experiment session, when each participant did the screening |
| Waitlist - UMN |
Participants will be added to a waitlist intervention group for 8-weeks between pre-and post-testing. |
| BG002 | Experienced Meditator - CMU | participants that have more than 1 year of regular meditation experience |
| BG003 | Meditation Naive - CMU | Participants that have no regular meditation experience |
| BG004 | Mindfulness Based Stress Reduction - CMU | 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. |
| BG005 | Waitlist - CMU | Participants will be added to a waitlist intervention group for 8-weeks between pre-and post-testing. |
| BG006 | Short Term Meditation - CMU - Meditation | Participants will undergo a 20-minute meditation between two Brain-computer interface sessions. |
| BG007 | Short Term Meditation - CMU - Control | Participants will listen to a 20-min reading of meditation related journal aritcle between two Brain-computer interface sessions. |
| BG008 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Prior regular meditation experience over 1 year | This measure is about whether a participant has a regular meditation experience of over 1 year, which defines a participant as an experienced meditator. | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | 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 Carnegie Mellon University (CMU). Mindfulness Based Stress Reduction: 8-week mindfulness based stress reduction course intended to develop mind-body awareness through mindfulness practices. |
| OG001 | 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 Carnegie Mellon University (CMU). |
|
|
|
| Primary | 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. | 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. | Posted | Median | Inter-Quartile Range | percentage of breath counting accuracy | 6 months for each participant. |
|
|
|
|
| Primary | 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | During the first experiment session, when each participant did the screening |
|
|
|
|
| 0 |
| 72 |
| 0 |
| 72 |
| 0 |
| 72 |
| EG001 | 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). | 0 | 72 | 0 | 72 | 0 | 72 |
| EG002 | Experienced Meditator - CMU | Participants that have more than 1 year of regular meditation experience, and will perform a series of brain-computer interface experiments. | 0 | 32 | 0 | 32 | 0 | 32 |
| EG003 | Meditation Naive - CMU | Participants that have no regular meditation experience, and will perform a series of brain-computer interface experiments. | 0 | 34 | 0 | 34 | 0 | 34 |
| EG004 | 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. | 0 | 8 | 0 | 8 | 0 | 8 |
| EG005 | 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). | 0 | 8 | 0 | 8 | 0 | 8 |
| EG006 | Short Term Meditation - CMU - Meditation | Participants will undergo a 20-minute meditation between two Brain-computer interface sessions. | 0 | 3 | 0 | 3 | 0 | 3 |
| EG007 | Short Term Meditation - CMU - Control | Participants will listen to a 20-min reading of meditation related journal article between two Brain-computer interface sessions. | 0 | 2 | 0 | 2 | 0 | 2 |
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| D004191 |
| Behavioral Disciplines and Activities |
| Wilcoxon (Mann-Whitney) |
| <0.05 |
| Mean Difference (Final Values) |
| 0.69 |
| 2-Sided |
| Equivalence |
The null hypothesis is that the MAAS scores of the two groups have equal medians. |
| Regression, Linear | <0.05 | significant if p<0.05 | correlation coefficient | 0.42 | 2-Sided | Other | This statistical test is about the correlation between baseline up-down BCI performance and the FMI score. A linear regression model is used to test if the slope is non-zero. |
| Regression, Linear | <0.05 | correlation coefficient | 0.41 | 2-Sided | Other | This statistical test is about the correlation between baseline up-down BCI performance and the MAAS score. A linear regression model is used to test if the slope is non-zero. |