Mindful Minds: Mindfulness-Based Neurofeedback for Underrepresented College Students

August 12, 2025 updated by: Amelia Saul, PhD, CTRS, BCB, Florida International University

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.

Study Overview

Status

Completed

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.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Miami, Florida, United States, 33199
        • Florida International University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mindfulness Neurofeedback

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.

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.
No Intervention: Business as Usual
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Academic Performance
Time Frame: From enrollment to the end of treatment 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. 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.
From enrollment to the end of treatment at 4 weeks
Academic Anxiety with Academic Anxiety Scale
Time Frame: From enrollment to the end of treatment at 4 weeks
The Academic Anxiety Scale (AAS) will be used to examine performance anxiety (Aim 1). 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).
From enrollment to the end of treatment at 4 weeks
Acceptability
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.
From enrollment to the end of treatment at 4 weeks
Feasibility
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.
From enrollment to the end of treatment at 4 weeks
Academic Anxiety with Beck Anxiety Inventory
Time Frame: From enrollment to the end of treatment at 4 weeks
The Beck Anxiety Inventory (BAI) will measure generalized anxiety 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.
From enrollment to the end of treatment at 4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attention with Mental Stress Assessment
Time Frame: From enrollment to the end of treatment at 4 weeks
The Mental Stress Assessment (MeSA) will also assess attention by measuring physiological responses during tasks designed to induce and evaluate stress-related attentional shifts.
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
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.
From enrollment to the end of treatment at 4 weeks
Attention with Integrated Visual and Auditory Continuous Performance Test
Time Frame: From enrollment to the end of treatment at 4 weeks
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.
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
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.
From enrollment to the end of treatment at 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Amelia D Saul, PhD, Florida International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2025

Primary Completion (Actual)

March 25, 2025

Study Completion (Actual)

March 25, 2025

Study Registration Dates

First Submitted

January 13, 2025

First Submitted That Met QC Criteria

January 16, 2025

First Posted (Actual)

January 20, 2025

Study Record Updates

Last Update Posted (Estimated)

August 15, 2025

Last Update Submitted That Met QC Criteria

August 12, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Anxiety

Clinical Trials on NeuroSky Mindfulness-Based Neurofeedback

Subscribe