Clinical trial NCT06784934: Mindful Minds: Mindfulness-Based Neurofeedback for Underrepresented College Students
Official title: Mindful Minds: Acceptability and Feasibility of Mindfulness-Based Neurofeedback Training for Racial and Ethnic Minority Scholars
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Academic Performance
Anxiety
Keywords: neurofeedback
underrepresented population
college students
academic performance
anxiety
mindfulness meditation
wearable devices
biofeedback
Heart Rate Variability
Alpha Neurofeedback
Lead sponsor: Florida International University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
First posted: 2025-01-20
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.")

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Academic Performance
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Academic Anxiety with Academic Anxiety Scale
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Acceptability
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Academic Anxiety with Beck Anxiety Inventory
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Feasibility
timeFrame: From enrollment to the end of treatment at 4 weeks
Secondary outcomes:
measure: Attention with Integrated Visual and Auditory Continuous Performance Test
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Increased Alpha Activity
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Attention with Mental Stress Assessment
timeFrame: From enrollment to the end of treatment at 4 weeks
measure: Heart Rate Variability
timeFrame: From enrollment to the end of treatment at 4 weeks
Other outcomes:
Locations:
city: Miami
country: United States
facility: Florida International University
state: Florida
Study officials:
affiliation: Florida International University
name: Amelia D Saul, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: Cassady JC, Pierson EE, Starling JM, editors. Predicting student depression with measures of general and academic anxieties. Frontiers in Education; 2019: Frontiers Media SA.
citation: 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.
citation: 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.
citation: Saul AD. The Efficacy of an Evidence-Based Biofeedback Intervention to Reduce Anxiety in College Students: East Carolina University; 2021.
citation: 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.
citation: 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.
citation: 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.
citation: 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.