- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06784934
Mindful Minds: Mindfulness-Based Neurofeedback for Underrepresented College Students
Mindful Minds: Acceptability and Feasibility of Mindfulness-Based Neurofeedback Training for Racial and Ethnic Minority Scholars
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Florida
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Miami, Florida, United States, 33199
- Florida International University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
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
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 |
|---|---|
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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.
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|
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.
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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.
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From enrollment to the end of treatment at 4 weeks
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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).
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From enrollment to the end of treatment at 4 weeks
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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.
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From enrollment to the end of treatment at 4 weeks
|
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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.
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From enrollment to the end of treatment at 4 weeks
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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.
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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.
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From enrollment to the end of treatment at 4 weeks
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Heart Rate Variability
Time Frame: From enrollment to the end of treatment at 4 weeks
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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.
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From enrollment to the end of treatment at 4 weeks
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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.
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From enrollment to the end of treatment at 4 weeks
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Increased Alpha Activity
Time Frame: From enrollment to the end of treatment at 4 weeks
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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.
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From enrollment to the end of treatment at 4 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amelia D Saul, PhD, Florida International University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 800-020-774
- U54MD012393 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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.
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