Academic PerformanceNCT06784934

Mindful Minds: Mindfulness-Based Neurofeedback for Underrepresented College Students

A study testing NeuroSky Mindfulness-Based Neurofeedback in people with Academic Performance and Anxiety, run by Florida International 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

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Trial summary

Who is it for?: Ages 18 to 30 yearsHealthy volunteers can take part
Conditions the study is for: Academic Performance, Anxiety
What is being tested?: NeuroSky Mindfulness-Based Neurofeedback
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 39 participants
Where: 1 siteUnited States
Study dates: 28 Jan 2025to 25 Mar 2025
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 30 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Aged between 18 and 30 years old
Currently enrolled in a 4-year university
Individuals from an ethnic or racial minority background (i.e., "The minority racial and ethnic groups defined by Office of Management and Budget's (OMB) are American Indian or Alaska Native, Asian, Black or African American, and Native Hawaiian or Pacific Islander. The ethnicity used is Latino or Hispanic.")

Who cannot join

Severe depression (cut off score of 15 or higher on Patient Health Questionnaire 9 (PHQ-9))
Previously receiving biofeedback training.
Severe medical condition (e.g., pacemaker, cardiac arrhythmia, hypertension, diabetes).
Showing symptoms of psychosis
Having a neurological condition (e.g., Parkinson's disease) that would complicate the interpretation of physiological data.
Taking medications such as SSRIs, alpha/beta-blockers, or withdrawal or maintenance medications (e.g., Librium, methadone)
Using substances such as tobacco and illicit drugs, and 8)alcohol consumption as defined by National Institute of Health (NIH) as "more than 2 drinks (1 drink for women) in a day or drinking more than 5 drinks (4 for women) on the same occasion (i.e., at the same time or within a couple of hours of each other) on at least 1 day in the past month" are excluded due to their potential to affect the data.

Trial locations and contacts

1 site in 1 country.

United States1 site

Florida International University
Miami, Florida, 33199

Other trials in United States

About this study

Official title: Mindful Minds: Acceptability and Feasibility of Mindfulness-Based Neurofeedback Training for Racial and Ethnic Minority Scholars

The study examines the efficacy of a mindfulness-based neurofeedback protocol designed to improve academic performance and reduce performance anxiety in racial and ethnic minority college students. Using NeuroSky and BrainTrain technology, the intervention incorporates mindfulness principles to enhance participants' self-regulation skills. Continuous heart rate variability (HRV) data is collected to assess stress levels, sleep, and exercise. The research aims to explore the acceptability and feasibility of this approach, with the goal of addressing academic performance and anxiety in this population.

Read the detailed description

The United States has witnessed a notable increase in the enrollment of racial and ethnic minority students (i.e., "The minority racial and ethnic groups defined by Office of Management and Budget's (OMB) are American Indian or Alaska Native, Asian, Black or African American, and Native Hawaiian or Pacific Islander. The ethnicity used is Latino or Hispanic"). With the rise in college enrollment has also come concerns about the challenges racial and ethnic minority students are facing, such as "experiencing microaggressions, discrimination, imposter syndrome, and negative campus climate," which have been found to contribute to mental health problems for minority college students. Those who identify as more than one race had the highest rate of anxiety (39.8%), followed by American Indian/Alaskan Native (39.1%), Arab/Arab American (35.2%) and Latino (35.2%).6 However, the majority of research about college students' mental health status and treatment is focused on the general college student population, with extensive studies having only small subsets of racial and ethnic minority student representation. Given the ubiquity of mental health challenges in college students, the development of an easily utilized, readily available, inexpensive, with minimal side-effects intervention is needed. Neurofeedback and mindfulness have both been found to show significant improvements in performance enhancement, anxiety reduction, and improved focus/awareness. Through continuous neurofeedback interventions, individuals tend to improve interoceptive awareness and develop mechanisms to facilitate emotional control. Mindfulness meditation can help individuals gain control of their attention, which may, in turn, help to facilitate control of thoughts and emotions. Currently, there is little research on the benefits of neurofeedback using mindfulness-based interventions to improve academic performance in students from racial and ethnic minority backgrounds. This research program responds to the urgent need for targeted interventions to enhance academic success and improve mental health among racial and ethnic minority students in higher education. Using a randomized control trial, 36 participants will be randomly assigned to either the 4-week mindfulness-based neurofeedback intervention or business as usual. The investigators hypothesize that participants in the experimental group will significantly improve test performance and reduce academic anxiety compared to the control group. Focused on examining the acceptability and feasibility of a mindfulness-based neurofeedback intervention, the study aims to address performance anxiety and improve test performance as well as mental health by providing real-time feedback and objective analysis to overcome the limitations of traditional stress management programs. The research also aims to offer a more accessible and practical approach, contributing valuable insights to promote equitable outcomes for underrepresented students.

Conditions: Academic Performance, Anxiety
Being tested: NeuroSky Mindfulness-Based Neurofeedback
Keywords: neurofeedback, underrepresented population, college students, academic performance, anxiety, mindfulness meditation, wearable devices, biofeedback, Heart Rate Variability, Alpha Neurofeedback
Medical subject headings: Anxiety Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NeuroSky Mindfulness-Based NeurofeedbackDevice
NeuroSky will monitor participants' brain response to the intervention and provide feedback based on the participants' performance. Neurofeedback Intervention: When practicing the mindfulness-based intervention, NeuroSky will provide instructions before beginning the sessions. Dr. Saul will assist with set up and answer any questions. The apps audio and visual feedback will assist the participants as they practice mindfulness meditation. Participants in the experimental group will practice for 10 minutes in the lab during Sessions 1 and 5 and then at home for 10-20 minutes daily for 4 weeks with weekly 10-minute virtual check-ins with Dr. Saul to ensure acceptability and feasibility. Dr. Saul will also monitor participants' progress using the secure participant portal and de-identified usernames available through NeuroSky.

Study groups in NCT06784934
Study group	Role	What they receive
Mindfulness Neurofeedback	Experimental	For the experimental group, participants will engage in a mindfulness-based neurofeedback training protocol designed to enhance academic performance and reduce performance anxiety. The intervention involves the use of NeuroSky and BrainTrain technology to provide real-time feedback on brain activity, helping participants develop better self-regulation skills. The training incorporates guided mindfulness exercises focused on promoting relaxation and sustained attention. After the training with the researcher, the experimental group participants will go home and practice independently (10 -15 minutes of mindfulness-based neurofeedback training once daily) with weekly 10-minute virtual check-ins for 4 weeks. Participants will also be asked to record 5 minutes of heart rate variability (HRV) data using the OptimalHRV device twice a day to measure their HRV. At the end of the study, participants will return to the lab for one final mindfulness-meditation session. Receives: Device: NeuroSky Mindfulness-Based Neurofeedback
Business as Usual	No intervention	The control group participants will not engage in mindfulness-based neurofeedback training. Participants in the control group will continue their daily routines without meditation for 4 weeks. Heart rate variability (HRV) will be monitored using the OptimalHRV device to monitor HRV, but no intervention will be provided. Weekly 10-minute virtual check-ins with the research team will ensure compliance, address questions, and maintain engagement. Data collected from the OptimalHRV device will provide a baseline for comparison, helping to evaluate the effectiveness of the neurofeedback intervention in the experimental group.

What is being measured

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

Total Correct Responses on the Verbal Mental Arithmetic Task - Final Session
Trier Social Stress Test will be utilized to induce performance anxiety through a mock job interview and mental arithmetic task conducted in front of a non-responsive committee at baseline and the final session (after 4 weeks). This test uses a standardized protocol that not only facilitates a more robust evaluation of our intervention but also elevates the ecological validity of the study by assessing its effects in a real-life scenario. The social stress test not only facilitates a more robust evaluation of our intervention but also elevates the ecological validity of the study by assessing its effects in a real-life scenario.
Measured: Final session at 4 weeks
Academic Anxiety at Final Session
The Academic Anxiety Scale (AAS) will be used to examine performance anxiety at baseline and final session (after 4 weeks). This 11-item questionnaire uses a 4-point Likert Scale (1 = not at all typical of me to 4 = very typical of me) and measures broader aspects of academic-based anxiety beyond cognitive factors. The AAS includes items designed to assess apprehension and anxiety in academic settings, with high reliability (split-half Guttman reliability of 0.91 and Cronbach's Alpha of 0.94).
Measured: Final session at 4 weeks
Number of Participants Reporting Weekly Experience Themes During the Intervention
Semi-structured interviews will be conducted during the weekly check-ins to further our understanding of the intervention's acceptability utilizing qualitative techniques such as thematic analysis.
Measured: From enrollment to the end of treatment at 4 weeks
Academic Anxiety With Beck Anxiety Inventory at Final Session
The Beck Anxiety Inventory (BAI) measured generalized anxiety at baseline and final session (after 4 weeks) using a 21-item Likert scale (0 to 3) to assess how distressing anxiety symptoms have been over the past week. Scores range from 0 to 63, with levels categorized as minimal (0-7), mild (8-15), moderate (16-25), and severe (30-63). The BAI has been widely used among racially diverse groups. The investigators hypothesize that BAI scores will vary significantly from pre- to post-intervention.
Measured: Final session at 4 weeks
Number of Participants Reporting Technology-Related Feasibility Issues During Weekly Check-Ins
Semi-structured interviews will be conducted during the weekly check-ins to further our understanding of the intervention's feasibility utilizing qualitative techniques such as thematic analysis.
Measured: From enrollment to the end of treatment at 4 weeks

Secondary outcomes (4)

Attention With Integrated Visual and Auditory Continuous Performance Test
The Integrated Visual and Auditory Continuous Performance Test (IVA-2) will be used to assess attention as a secondary outcome. This computerized test measures both visual and auditory attention, providing an overall score of attentional functioning and response control. It evaluates sustained attention, impulsivity, and processing speed through a series of tasks requiring quick and accurate responses.The scores range from 0 to 145, with a mean of 100 and a standard deviation of 15. Higher scores reflect better performance. Scores of zero are valid, indicating performance 6.65 SD below average. The test includes a validity check (p < .01) for random responses, allowing scores to be set to zero if effort was made. Rating scales are available for additional validity assessment.
Measured: From enrollment to the end of treatment at 4 weeks
Increased Alpha Activity
The NeuroSky device will be used to measure alpha brainwave activity, a marker of relaxation and focused attention, as a secondary outcome. Mindfulness-based neurofeedback training will aim to enhance alpha activity by providing participants with real-time feedback on their brainwave patterns. During each session, participants will learn to modulate their alpha levels through mindfulness techniques, fostering a state of calm alertness. Increased alpha activity is associated with improved emotional regulation, reduced stress, and enhanced cognitive functioning. Pre- and post-intervention alpha activity levels will be compared to evaluate the effectiveness of the mindfulness-based neurofeedback training.
Measured: From enrollment to the end of treatment at 4 weeks
Attention With Mental Stress Assessment
The Mental Stress Assessment (MeSA) will also assess attention by measuring physiological responses during tasks designed to induce and evaluate stress-related attentional shifts.
Measured: From enrollment to the end of treatment at 4 weeks
Heart Rate Variability
Heart Rate Variability (HRV) will be measured using the OptimalHRV device. We will examine HRV to determine if participants HRV increased from pre- to post-test which would be an indication of improved autonomic nervous system balance.
Measured: From enrollment to the end of treatment at 4 weeks

Timeline

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

28 Jan 202525 Mar 2025

First posted20 Jan 2025
Study start28 Jan 2025
Primary completion25 Mar 2025
Study completion25 Mar 2025

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.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Academic PerformanceStudies 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06784934
Sponsor's protocol ID: 800-020-774
Other IDs: U54MD012393
Status last verified: Jun 2026
First submitted: 13 Jan 2025
Last updated: 4 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided: The investigators recognize the importance of sharing Individual Participant Data (IPD) to advance scientific discovery and promote transparency in research. While protecting participant privacy and adhering to ethical and regulatory guidelines remains a top priority, the investigators are exploring options to make IPD from this study available under appropriate conditions. Any shared data will be fully de-identified to safeguard participant privacy and minimize the risk of re-identification. Data sharing will occur through secure, controlled-access repositories or upon request, with approval contingent on a data use agreement to ensure responsible use. Furthermore, data sharing will align with the informed consent provided by participants, respecting their rights and preferences. The investigators will also limit shared data to specific research purposes that align with the study's objectives and have the potential to benefit the broader scientific community.

Publications

Rogers JM, Johnstone SJ, Aminov A, Donnelly J, Wilson PH. Test-retest reliability of a single-channel, wireless EEG system. Int J Psychophysiol. 2016 Aug;106:87-96. doi: 10.1016/j.ijpsycho.2016.06.006. Epub 2016 Jun 16.
PubMed 27318008
Stinson B, Arthur D. A novel EEG for alpha brain state training, neurobiofeedback and behavior change. Complement Ther Clin Pract. 2013 Aug;19(3):114-8. doi: 10.1016/j.ctcp.2013.03.003. Epub 2013 Apr 19.
PubMed 23890456
Hunkin H, King DL, Zajac IT. Evaluating the feasibility of a consumer-grade wearable EEG headband to aid assessment of state and trait mindfulness. J Clin Psychol. 2021 Nov;77(11):2559-2575. doi: 10.1002/jclp.23189. Epub 2021 Jun 1.
PubMed 34061998
Hunt CA, Hoffman MA, Mohr JJ, Williams AL. Assessing Perceived Barriers to Meditation: the Determinants of Meditation Practice Inventory-Revised (DMPI-R). Mindfulness (N Y). 2020 May;11(5):1139-1149. doi: 10.1007/s12671-020-01308-7. Epub 2020 Feb 10.
PubMed 33664878
Russell L, Orellana L, Ugalde A, Milne D, Krishnasamy M, Chambers R, Livingston PM. Exploring Knowledge, Attitudes, and Practice Associated With Meditation Among Patients With Melanoma. Integr Cancer Ther. 2018 Jun;17(2):237-247. doi: 10.1177/1534735417699514. Epub 2017 Mar 24.
PubMed 28627247
Allen AP, Kennedy PJ, Dockray S, Cryan JF, Dinan TG, Clarke G. The Trier Social Stress Test: Principles and practice. Neurobiol Stress. 2016 Nov 12;6:113-126. doi: 10.1016/j.ynstr.2016.11.001. eCollection 2017 Feb.
PubMed 28229114
Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.
PubMed 3204199
Cassady JC, Pierson EE, Starling JM, editors. Predicting student depression with measures of general and academic anxieties. Frontiers in Education; 2019: Frontiers Media SA.
Bigliassi M, Galano BM, Lima-Silva AE, Bertuzzi R. Effects of mindfulness on psychological and psychophysiological responses during self-paced walking. Psychophysiology. 2020 Apr;57(4):e13529. doi: 10.1111/psyp.13529. Epub 2020 Jan 17.
PubMed 31953844
Saul AD, Fish MT. Anxiety and college students: The benefits of mindfulness-based meditation. Recreation, Parks, and Tourism in Public Health. 2019;3(1):139-54.
Saul AD. The Efficacy of an Evidence-Based Biofeedback Intervention to Reduce Anxiety in College Students: East Carolina University; 2021.
Fish MT, Saul AD. The gamification of meditation: a randomized-controlled study of a prescribed mobile mindfulness meditation application in reducing college students' depression. Simulation & Gaming. 2019;50(4):419-35.
Russ SL, Maruyama G, Sease TB, Jellema S. Do early experiences matter? Development of an Early Meditation Hindrances Scale linked to novice meditators' intention to persist. Psychology of Consciousness: Theory, Research, and Practice. 2017;4(3):274.
Kiken LG, Garland EL, Bluth K, Palsson OS, Gaylord SA. From a state to a trait: Trajectories of state mindfulness in meditation during intervention predict changes in trait mindfulness. Pers Individ Dif. 2015 Jul 1;81:41-46. doi: 10.1016/j.paid.2014.12.044.
PubMed 25914434
Garland EL, Hanley A, Farb NA, Froeliger BE. State Mindfulness During Meditation Predicts Enhanced Cognitive Reappraisal. Mindfulness (N Y). 2015 Apr 1;6(2):234-242. doi: 10.1007/s12671-013-0250-6.
PubMed 26085851

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?

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Study at a glance

From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mindful Minds: Acceptability and Feasibility of Mindfulness-Based Neurofeedback Training for Racial and Ethnic Minority Scholars
ClinicalTrials.gov ID: NCT06784934
Acronym / sponsor ID: 800-020-774
Conditions: Academic Performance, Anxiety
Keywords: neurofeedback, underrepresented population, college students, academic performance, anxiety, mindfulness meditation, wearable devices, biofeedback
Study type: Interventional
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Florida International UniversityUniversity, hospital or other
Collaborators: National Institute on Minority Health and Health Disparities (NIMHD)
Study start: 28 Jan 2025 (actual)
Primary completion: 25 Mar 2025 (actual)
Study completion: 25 Mar 2025 (actual)
First posted: 20 Jan 2025 (actual)
Results: Posted 4 Aug 2026

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: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Mindfulness Neurofeedback	Experimental	Device: NeuroSky Mindfulness-Based NeurofeedbackFor the experimental group, participants will engage in a mindfulness-based neurofeedback training protocol designed to enhance academic performance and reduce performance anxiety. The intervention involves the use of NeuroSky and BrainTrain technology to provide real-time feedback on brain activity, helping participants develop better self-regulation skills. The training incorporates guided mindfulness exercises focused on promoting relaxation and sustained attention. After the training with the researcher, the experimental group participants will go home and practice independently (10 -15 minutes of mindfulness-based neurofeedback training once daily) with weekly 10-minute virtual check-ins for 4 weeks. Participants will also be asked to record 5 minutes of heart rate variability (HRV) data using the OptimalHRV device twice a day to measure their HRV. At the end of the study, participants will return to the lab for one final mindfulness-meditation session.
Business as Usual	No intervention	–The control group participants will not engage in mindfulness-based neurofeedback training. Participants in the control group will continue their daily routines without meditation for 4 weeks. Heart rate variability (HRV) will be monitored using the OptimalHRV device to monitor HRV, but no intervention will be provided. Weekly 10-minute virtual check-ins with the research team will ensure compliance, address questions, and maintain engagement. Data collected from the OptimalHRV device will provide a baseline for comparison, helping to evaluate the effectiveness of the neurofeedback intervention in the experimental group.

Who may qualify

Ages: 18 to 30 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

Aged between 18 and 30 years old
Currently enrolled in a 4-year university
Individuals from an ethnic or racial minority background (i.e., "The minority racial and ethnic groups defined by Office of Management and Budget's (OMB) are American Indian or Alaska Native, Asian, Black or African American, and Native Hawaiian or Pacific Islander. The ethnicity used is Latino or Hispanic.")

Key exclusion criteria (7 listed)

Severe depression (cut off score of 15 or higher on Patient Health Questionnaire 9 (PHQ-9))
Previously receiving biofeedback training.
Severe medical condition (e.g., pacemaker, cardiac arrhythmia, hypertension, diabetes).
Showing symptoms of psychosis
Having a neurological condition (e.g., Parkinson's disease) that would complicate the interpretation of physiological data.

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
NeuroSky Mindfulness-Based NeurofeedbackNeuroSky will monitor participants' brain response to the intervention and provide feedback based on the participants' performance. Neurofeedback Intervention: When practicing the mindfulness-based intervention, NeuroSky will provide instructions before beginning the sessions. Dr. Saul will assist with set up and answer any questions. The apps audio and visual feedback will assist the participants as they practice mindfulness meditation. Participants in the experimental group will practice for 10 minutes in the lab during Sessions 1 and 5 and then at home for 10-20 minutes daily for 4 weeks with weekly 10-minute virtual check-ins with Dr. Saul to ensure acceptability and feasibility. Dr. Saul will also monitor participants' progress using the secure participant portal and de-identified usernames available through NeuroSky.	Device	Mindfulness Neurofeedback

Primary outcome

Total Correct Responses on the Verbal Mental Arithmetic Task - Final Session
Time frame: Final session at 4 weeks
Trier Social Stress Test will be utilized to induce performance anxiety through a mock job interview and mental arithmetic task conducted in front of a non-responsive committee at baseline and the final session (after 4 weeks). This test uses a standardized protocol that not only facilitates a more robust evaluation of our intervention but also elevates the ecological validity of the study by assessing its effects in a real-life scenario. The social stress test not only facilitates a more robust evaluation of our intervention but also elevates the ecological validity of the study by assessing its effects in a real-life scenario.
Academic Anxiety at Final Session
Time frame: Final session at 4 weeks
The Academic Anxiety Scale (AAS) will be used to examine performance anxiety at baseline and final session (after 4 weeks). This 11-item questionnaire uses a 4-point Likert Scale (1 = not at all typical of me to 4 = very typical of me) and measures broader aspects of academic-based anxiety beyond cognitive factors. The AAS includes items designed to assess apprehension and anxiety in academic settings, with high reliability (split-half Guttman reliability of 0.91 and Cronbach's Alpha of 0.94).
Number of Participants Reporting Weekly Experience Themes During the Intervention
Time frame: From enrollment to the end of treatment at 4 weeks
Semi-structured interviews will be conducted during the weekly check-ins to further our understanding of the intervention's acceptability utilizing qualitative techniques such as thematic analysis.
Academic Anxiety With Beck Anxiety Inventory at Final Session
Time frame: Final session at 4 weeks
The Beck Anxiety Inventory (BAI) measured generalized anxiety at baseline and final session (after 4 weeks) using a 21-item Likert scale (0 to 3) to assess how distressing anxiety symptoms have been over the past week. Scores range from 0 to 63, with levels categorized as minimal (0-7), mild (8-15), moderate (16-25), and severe (30-63). The BAI has been widely used among racially diverse groups. The investigators hypothesize that BAI scores will vary significantly from pre- to post-intervention.
Number of Participants Reporting Technology-Related Feasibility Issues During Weekly Check-Ins
Time frame: From enrollment to the end of treatment at 4 weeks
Semi-structured interviews will be conducted during the weekly check-ins to further our understanding of the intervention's feasibility utilizing qualitative techniques such as thematic analysis.

4 secondary outcomes

Attention With Integrated Visual and Auditory Continuous Performance Test
Time frame: From enrollment to the end of treatment at 4 weeks
Increased Alpha Activity
Time frame: From enrollment to the end of treatment at 4 weeks
Attention With Mental Stress Assessment
Time frame: From enrollment to the end of treatment at 4 weeks
Heart Rate Variability
Time frame: From enrollment to the end of treatment at 4 weeks

Results and safety

Results posted to the registry on 4 Aug 2026, 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 Neurofeedback	19	18
Business as Usual	19	16

Primary outcome: Total Correct Responses on the Verbal Mental Arithmetic Task - Final Session

Time frame: Final session at 4 weeks. Mean (Standard Deviation). Unit: Responses

Measure	Mindfulness Neurofeedback n = 18	Business as Usual n = 16
Value	6.29 (6.15)	6.94 (4.06)

Population analysed: Participants were included if they completed the study and had initial and final verbal mental arithmetic task data. One mindfulness neurofeedback participant and three BAU participants were excluded because they discontinued the intervention before the final session.

Primary outcome: Academic Anxiety at Final Session

Time frame: Final session at 4 weeks. Mean (Standard Deviation). Unit: score

Measure	Mindfulness Neurofeedback n = 18	Business as Usual n = 16
Value	18.94 (6.06)	19.00 (4.83)

Population analysed: Baseline analyses included all participants, while outcome analyses included only those with complete follow-up data.

Primary outcome: Number of Participants Reporting Weekly Experience Themes During the Intervention

Time frame: From enrollment to the end of treatment at 4 weeks. Count of participants. Unit: Participants

Measure	Mindfulness Neurofeedback n = 16	Business as Usual n = 17
Reported a positive or acceptable overall experience	15	17
Reported a technology/device challenge	8	8
Reported adherence, time, or routine barriers	8	9
Reported stress, illness, or life events affecting experience	9	8
Reported perceived benefits such as relaxation, focus, or self-regulation	4	7

Population analysed: Participants with at least one completed weekly check-in response for the weekly experience question.

Primary outcome: Academic Anxiety With Beck Anxiety Inventory at Final Session

Time frame: Final session at 4 weeks. Median (Standard Deviation). Unit: score

Measure	Mindfulness Neurofeedback n = 18	Business as Usual n = 16
Value	32.53 (11.09)	33.06 (7.05)

Population analysed: Baseline analyses included all participants, while outcome analyses included only those with complete follow-up data.

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From enrollment until end of follow-up, at 4 weeks.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mindfulness Neurofeedback	0 of 19 (0%)	0 of 19 (0%)	0 of 19
Business as Usual	0 of 19 (0%)	0 of 19 (0%)	0 of 19

Limitations and caveats (from the sponsor): This study was designed as a pilot feasibility trial; therefore, the primary focus was on feasibility rather than efficacy, which limits conclusions regarding intervention effects. The modest sample size reduces statistical power and limits generalizability. Additionally, the control group participated in an active condition that included HRV monitoring, which may have influenced outcomes and reduced the ability to isolate intervention effects. Future studies should include larger samples and mu

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27318008Rogers JM, Johnstone SJ, Aminov A, Donnelly J, Wilson PH. Test-retest reliability of a single-channel, wireless EEG system. Int J Psychophysiol. 2016 Aug;106:87-96. doi: 10.1016/j.ijpsycho.2016.06.006. Epub 2016 Jun 16.
Background: PubMed 23890456Stinson B, Arthur D. A novel EEG for alpha brain state training, neurobiofeedback and behavior change. Complement Ther Clin Pract. 2013 Aug;19(3):114-8. doi: 10.1016/j.ctcp.2013.03.003. Epub 2013 Apr 19.
Background: PubMed 34061998Hunkin H, King DL, Zajac IT. Evaluating the feasibility of a consumer-grade wearable EEG headband to aid assessment of state and trait mindfulness. J Clin Psychol. 2021 Nov;77(11):2559-2575. doi: 10.1002/jclp.23189. Epub 2021 Jun 1.
Background: PubMed 33664878Hunt CA, Hoffman MA, Mohr JJ, Williams AL. Assessing Perceived Barriers to Meditation: the Determinants of Meditation Practice Inventory-Revised (DMPI-R). Mindfulness (N Y). 2020 May;11(5):1139-1149. doi: 10.1007/s12671-020-01308-7. Epub 2020 Feb 10.
Background: PubMed 28627247Russell L, Orellana L, Ugalde A, Milne D, Krishnasamy M, Chambers R, Livingston PM. Exploring Knowledge, Attitudes, and Practice Associated With Meditation Among Patients With Melanoma. Integr Cancer Ther. 2018 Jun;17(2):237-247. doi: 10.1177/1534735417699514. Epub 2017 Mar 24.
Background: PubMed 28229114Allen AP, Kennedy PJ, Dockray S, Cryan JF, Dinan TG, Clarke G. The Trier Social Stress Test: Principles and practice. Neurobiol Stress. 2016 Nov 12;6:113-126. doi: 10.1016/j.ynstr.2016.11.001. eCollection 2017 Feb.
Background: PubMed 3204199Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.
BackgroundCassady JC, Pierson EE, Starling JM, editors. Predicting student depression with measures of general and academic anxieties. Frontiers in Education; 2019: Frontiers Media SA.
Background: PubMed 31953844Bigliassi M, Galano BM, Lima-Silva AE, Bertuzzi R. Effects of mindfulness on psychological and psychophysiological responses during self-paced walking. Psychophysiology. 2020 Apr;57(4):e13529. doi: 10.1111/psyp.13529. Epub 2020 Jan 17.
BackgroundSaul AD, Fish MT. Anxiety and college students: The benefits of mindfulness-based meditation. Recreation, Parks, and Tourism in Public Health. 2019;3(1):139-54.
BackgroundSaul AD. The Efficacy of an Evidence-Based Biofeedback Intervention to Reduce Anxiety in College Students: East Carolina University; 2021.
BackgroundFish MT, Saul AD. The gamification of meditation: a randomized-controlled study of a prescribed mobile mindfulness meditation application in reducing college students' depression. Simulation & Gaming. 2019;50(4):419-35.
IVA-2 Attention AssessmentLink provided by the sponsor.
MeSA Attention AssessmentLink provided by the sponsor.
Calm Awareness AppLink provided by the sponsor.
BrainTrain SmartMindLink provided by the sponsor.
Individual participant dataSharing planned: Undecided. The investigators recognize the importance of sharing Individual Participant Data (IPD) to advance scientific discovery and promote transparency in research. While protecting participant privacy and adhering to ethical and regulatory guidelines remains a top priority, the investigators are exploring options to make IPD from this study available under appropriate conditions. Any shared data will be fully de-identified to safeguard participant privacy and minimize the risk of re-identification. Data sharing will occur through secure, controlled-access repositories or upon request, with approval contingent on a data use agreement to ensure responsible use. Furthermore, data sharing will align with the informed consent provided by participants, respecting their rights and preferences. The investigators will also limit shared data to specific research purposes that align with the study's objectives and have the potential to benefit the broader scientific community.

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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.

Amelia D Saul, PhD principal investigator

Florida International 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 NeuroSky Mindfulness-Based Neurofeedback in people with Academic Performance and Anxiety, run by Florida International 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 3 inclusion and 7 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 4 Aug 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 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 4 Aug 2026). 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?

Total Correct Responses on the Verbal Mental Arithmetic Task - Final Session (time frame: Final session at 4 weeks). The study lists 5 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 NCT06784934, which also lists 15 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 4 Aug 2026.