Mindfulness-Based Neurofeedback for Anxiety

Overseen By Marcelo Bigliassi, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Florida International University

Must not be taking: SSRIs, Alpha/beta-blockers, others

Disqualifiers: Severe depression, Psychosis, Neurological conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 4 weeks

36 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

If you are taking medications like SSRIs (a type of antidepressant), alpha/beta-blockers (used for heart conditions), or withdrawal/maintenance medications, you would not be eligible to participate in this trial.

What data supports the effectiveness of the treatment Mindfulness-Based Neurofeedback for Anxiety?

Research shows that neurofeedback, which involves training the brain to change its activity, can help reduce anxiety by altering brain connectivity and improving control over anxiety symptoms. Mindfulness-based neurofeedback has been found to positively affect brain activity patterns, leading to anxiety relief and improved mindfulness ability. ^{1 2 3 4 5}

Is Mindfulness-Based Neurofeedback safe for humans?

Neurofeedback, including Mindfulness-Based Neurofeedback, is generally considered safe, but some people may experience temporary side effects like headaches or fatigue. These effects are usually mild and go away on their own. ^{6 7 8 9 10}

How does Mindfulness-Based Neurofeedback treatment differ from other anxiety treatments?

Mindfulness-Based Neurofeedback is unique because it combines mindfulness practices with real-time feedback on brain activity to help patients learn to control anxiety-related brain regions. Unlike traditional therapies that rely on medication or talk therapy, this approach uses neurofeedback to create lasting changes in brain connectivity, potentially offering a more direct and sustained impact on anxiety symptoms. ^{1 4 11 12 13}

Research Team

Amelia D Saul, PhD

Principal Investigator

Florida International University

Eligibility Criteria

This trial is for racial and ethnic minority college students who are looking to improve their academic performance and reduce anxiety. Participants should be interested in trying a mindfulness-based neurofeedback program using NeuroSky technology.

Inclusion Criteria

Individuals from an ethnic or racial minority background (i.e., American Indian or Alaska Native, Asian, Black or African American, Native Hawaiian or Pacific Islander, Latino or Hispanic ethnicity)

Currently enrolled in a 4-year university

Exclusion Criteria

I have severe depression, scoring 15 or higher on the PHQ-9.

I am experiencing symptoms like hallucinations or delusions.

I do not use tobacco or illicit drugs and drink within NIH guidelines.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a 4-week mindfulness-based neurofeedback training protocol designed to enhance academic performance and reduce performance anxiety.

4 weeks

Weekly 10-minute virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Mindfulness-Based Neurofeedback

Trial Overview The study tests a mindfulness-based neurofeedback protocol with NeuroSky and BrainTrain tech, aiming to boost self-regulation skills which may help with school work and lower stress related to performance.

Participant Groups

Group I: Mindfulness Neurofeedback Experimental Treatment 1 Intervention

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.

Group II: Business as Usual Active Control 1 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 Is Running the Clinical Trial?

Florida International University

Lead Sponsor

Trials

114

Recruited

19,400+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Findings from Research

Functional magnetic resonance imaging (fMRI) neurofeedback (NF) effectively reduced contamination anxiety in subjects by allowing them to learn to modulate activity in the orbitofrontal cortex, a brain region linked to anxiety.

The study demonstrated that NF not only altered brain connectivity patterns during training but also led to lasting changes in anxiety regulation, with improvements persisting several days after training, unlike the sham control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Orbitofrontal cortex neurofeedback produces lasting changes in contamination anxiety and resting-state connectivity. Scheinost, D., Stoica, T., Saksa, J., et al.[2021]

Neurofeedback therapy shows promise in managing anxiety and stress among adults with chronic illnesses, although the review aims to identify specific systems and protocols that are most effective.

The systematic examination will provide a clearer understanding of the level of evidence supporting neurofeedback as a therapeutic option for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of neurofeedback therapy for anxiety and stress in adults living with a chronic illness: a systematic review protocol. Blaskovits, F., Tyerman, J., Luctkar-Flude, M.[2019]

Neurofeedback is a noninvasive treatment that uses brainwave analysis to help patients with central nervous system issues, especially when traditional therapies like medication and psychotherapy are ineffective.

While there are many clinical case studies supporting the efficacy of neurofeedback, there is still a need for more controlled studies in peer-reviewed journals to further validate its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback: an emerging technology for treating central nervous system dysregulation. Larsen, S., Sherlin, L.[2013]

A study involving 34 participants (17 with anxiety disorder and 17 healthy individuals) demonstrated that mindfulness regulation through neurofeedback positively affects brain activity, as indicated by increased gamma wave power, which is associated with reduced anxiety.

The results showed significant improvements in mindfulness and anxiety relief, with statistical analysis confirming the effectiveness of the neurofeedback method (P < 0.05), providing an objective evaluation of treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy Evaluation of Neurofeedback-Based Anxiety Relief. Chen, C., Xiao, X., Belkacem, AN., et al.[2021]

In a study involving 36 clients with anxiety neurosis, training to reduce frontalis muscle tension through EMG biofeedback led to significant decreases in muscle tension during both feedback and no-feedback phases.

As clients gained better control over their muscle tension, they reported greater reductions in state anxiety and anxiety symptoms, suggesting that EMG biofeedback can positively influence cognitive aspects of anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Emg biofeedback ii: the dose-response relationship. Sargunaraj, D., Kumaraiah, V., Subbakrishna, DK.[2021]

A single session of EEG neurofeedback training in 21 individuals with PTSD led to decreased alpha rhythm amplitude during training and a subsequent 'rebound' increase in alpha synchronization, indicating a potential homeostatic response in the brain.

This rebound effect was associated with increased feelings of calmness and enhanced connectivity in brain networks related to emotional regulation, suggesting that neurofeedback may help improve regulatory systems in individuals with PTSD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Plastic modulation of PTSD resting-state networks and subjective wellbeing by EEG neurofeedback. Kluetsch, RC., Ros, T., Théberge, J., et al.[2022]

EEG neurofeedback (EEG NF) is a promising non-invasive method that can help modulate brain activity related to anxiety disorders and PTSD, potentially improving symptoms of over-arousal.

While positive effects of EEG NF have been observed, the exact relationship between symptom improvement and neurophysiological changes remains uncertain due to methodological issues in existing studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

EEG Neurofeedback for Anxiety Disorders and Post-Traumatic Stress Disorders: A Blueprint for a Promising Brain-Based Therapy. Micoulaud-Franchi, JA., Jeunet, C., Pelissolo, A., et al.[2021]

Neurofeedback training, while beneficial, can lead to transient adverse side effects, as shown in a study involving 30 healthy undergraduate students over ten sessions.

Most participants reported experiencing side effects, with the Sensory Motor Rhythm protocol being particularly sensitive to these adverse effects, indicating the need for careful monitoring during neurofeedback treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transient Adverse Side Effects During Neurofeedback Training: A Randomized, Sham-Controlled, Double Blind Study. Rogel, A., Guez, J., Getter, N., et al.[2015]

A study involving 33 healthy participants demonstrated that neurofeedback training targeting sensorimotor rhythm (SMR) can effectively increase SMR power and reduce anxiety levels over six training sessions conducted over two weeks.

The results showed a significant correlation between increased SMR activity and decreased anxiety severity, suggesting that this neurofeedback approach could be a promising method for anxiety relief in healthy individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sensorimotor rhythm neurofeedback training relieves anxiety in healthy people. Liu, S., Hao, X., Liu, X., et al.[2023]

In a study involving 45 individuals with generalized anxiety disorder, all treatment groups showed significant reductions in anxiety levels and psychophysiological symptoms after 8 sessions of biofeedback or a control condition.

Only the group receiving biofeedback to increase EEG alpha demonstrated a significant reduction in heart rate reactivity to stress, suggesting this method may be particularly effective for managing physiological responses to stress.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biofeedback treatments of generalized anxiety disorder: preliminary results. Rice, KM., Blanchard, EB., Purcell, M.[2019]

A 39-year-old woman with generalized anxiety disorder (GAD) showed significant improvement in her anxiety and depression symptoms after a seven-week heart rate variability (HRV) biofeedback training, moving from severe anxiety to mild and from mild to minimal depression.

The benefits of HRV biofeedback were maintained at a four-week follow-up, suggesting its potential as an effective adjunctive treatment for GAD, although more research is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heart Rate Variability Biofeedback as Adjunctive Treatment of Generalized Anxiety Disorder: A Case Report. Park, SJ., Roth, M.[2023]

In a study involving 23 patients with comorbid major depressive disorder and anxiety, a high beta down-training neurofeedback protocol effectively reduced high beta activity in the brain, which was associated with decreased severity of cognitive depression.

The training showed positive results across multiple sessions, confirming that the neurofeedback approach is trainable and can lead to meaningful changes in brain activity related to emotional regulation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The learning effects and curves during high beta down-training neurofeedback for patients with major depressive disorder. Chen, TC., Lin, IM.[2021]

A study involving 32 high trait anxious participants demonstrated that real-time functional magnetic resonance imaging neurofeedback (rt-fMRI-nf) can enhance connectivity between the dorsolateral prefrontal cortex and anterior cingulate cortex, which is important for attentional control.

Participants receiving rt-fMRI-nf showed reduced anxiety levels and increased functional connectivity post-training, indicating that this method may be effective for managing trait anxiety, although it did not improve performance on attentional tasks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using connectivity-based real-time fMRI neurofeedback to modulate attentional and resting state networks in people with high trait anxiety. Morgenroth, E., Saviola, F., Gilleen, J., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Orbitofrontal cortex neurofeedback produces lasting changes in contamination anxiety and resting-state connectivity. [2021]

2. Australia pubmed.ncbi.nlm.nih.gov

Effectiveness of neurofeedback therapy for anxiety and stress in adults living with a chronic illness: a systematic review protocol. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Neurofeedback: an emerging technology for treating central nervous system dysregulation. [2013]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy Evaluation of Neurofeedback-Based Anxiety Relief. [2021]

5. India pubmed.ncbi.nlm.nih.gov

Emg biofeedback ii: the dose-response relationship. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Plastic modulation of PTSD resting-state networks and subjective wellbeing by EEG neurofeedback. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

EEG Neurofeedback for Anxiety Disorders and Post-Traumatic Stress Disorders: A Blueprint for a Promising Brain-Based Therapy. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

Transient Adverse Side Effects During Neurofeedback Training: A Randomized, Sham-Controlled, Double Blind Study. [2015]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Sensorimotor rhythm neurofeedback training relieves anxiety in healthy people. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Biofeedback treatments of generalized anxiety disorder: preliminary results. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Heart Rate Variability Biofeedback as Adjunctive Treatment of Generalized Anxiety Disorder: A Case Report. [2023]

12. Netherlands pubmed.ncbi.nlm.nih.gov

The learning effects and curves during high beta down-training neurofeedback for patients with major depressive disorder. [2021]

13. Netherlands pubmed.ncbi.nlm.nih.gov

Using connectivity-based real-time fMRI neurofeedback to modulate attentional and resting state networks in people with high trait anxiety. [2021]