Mindfulness-Based Neurofeedback for Anxiety
Recruiting in Palo Alto (17 mi)
Overseen ByAmelia D Saul, PhD
Age: 18 - 65
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Florida International University
No Placebo Group
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.
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.
1561012How 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.
4891113What 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.
234711Will 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.
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
I am between 18 and 30 years old.
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.
I do not have a neurological condition like Parkinson's that affects data interpretation.
I have undergone biofeedback training before.
I have a severe medical condition like heart issues or diabetes.
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Mindfulness NeurofeedbackExperimental Treatment1 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 UsualActive Control1 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.
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Florida International UniversityMiami, FL
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Who is running the clinical trial?
Florida International UniversityLead Sponsor
National Institute on Minority Health and Health Disparities (NIMHD)Collaborator
References
Biofeedback treatments of generalized anxiety disorder: preliminary results. [2019]Forty-five individuals with generalized anxiety (38 with GAD as defined by DSM-III) were randomized to 4 treatment conditions or a waiting list control. Patients received 8 sessions of either frontal EMG biofeedback, biofeedback to increase EEG alpha, biofeedback to decrease EEG alpha, or a pseudomeditation control condition. All treated subjects showed significant reductions in STAI-Trait Anxiety and psychophysiologic symptoms on the Psychosomatic Symptom Checklist. Only alpha-increase biofeedback subjects showed significant reductions in heart rate reactivity to stressors at a separate psychophysiological testing session. Decreased self-report of anxiety was maintained at 6 weeks posttreatment.
Emg biofeedback ii: the dose-response relationship. [2021]36 clients with anxiety neurosis were trained to reduce frontalis muscle tension over two phases of ten sessions each. They were assessed on psychological and physiological measures, before, during and after the phases. The data analysis indicated that the clients succeeded in lowering frontalis muscle tension levels during the feedback and no-feedback phases of the training sessions. The inter-correlations among the outcome measures indicated that with an increasing amount of control of muscle tensior, the clients perceived greater amounts of change in state anxiety and in anxiety symptoms. This implies that EMG biofeedback can effect cognitive changes in clients.
Neurofeedback: an emerging technology for treating central nervous system dysregulation. [2013]Neurofeedback is a machine-mediated noninvasive treatment modality based on the analysis and "feeding back" of electroencephalogram brainwaves, which has shown efficacy with a variety of central nervous system-based problems. It has special application where patients have adverse reaction to psychopharmacologic treatments and psychotherapy, cognitive behavioral therapy, and dialectical behavior therapy have proved ineffective. Treatment modalities include active forms based on operant conditioning, involving a subject's response to stimuli. Neurofeedback is strong in clinical confirmations of efficacy (case studies) and has thus far limited controlled studies in the peer-reviewed journals.
Orbitofrontal cortex neurofeedback produces lasting changes in contamination anxiety and resting-state connectivity. [2021]Anxiety is a core human emotion but can become pathologically dysregulated. We used functional magnetic resonance imaging (fMRI) neurofeedback (NF) to noninvasively alter patterns of brain connectivity, as measured by resting-state fMRI, and to reduce contamination anxiety. Activity of a region of the orbitofrontal cortex associated with contamination anxiety was measured in real time and provided to subjects with significant but subclinical anxiety as a NF signal, permitting them to learn to modulate the target brain region. NF altered network connectivity of brain regions involved in anxiety regulation: subjects exhibited reduced resting-state connectivity in limbic circuitry and increased connectivity in the dorsolateral prefrontal cortex. NF has been shown to alter brain connectivity in other contexts, but it has been unclear whether these changes persist; critically, we observed changes in connectivity several days after the completion of NF training, demonstrating that such training can lead to lasting modifications of brain functional architecture. Training also increased subjects' control over contamination anxiety several days after the completion of NF training. Changes in resting-state connectivity in the target orbitofrontal region correlated with these improvements in anxiety. Matched subjects undergoing a sham feedback control task showed neither a reorganization of resting-state functional connectivity nor an improvement in anxiety. These data suggest that NF can enable enhanced control over anxiety by persistently reorganizing relevant brain networks and thus support the potential of NF as a clinically useful therapy.
Plastic modulation of PTSD resting-state networks and subjective wellbeing by EEG neurofeedback. [2022]Electroencephalographic (EEG) neurofeedback training has been shown to produce plastic modulations in salience network and default mode network functional connectivity in healthy individuals. In this study, we investigated whether a single session of neurofeedback training aimed at the voluntary reduction of alpha rhythm (8-12 Hz) amplitude would be related to differences in EEG network oscillations, functional MRI (fMRI) connectivity, and subjective measures of state anxiety and arousal in a group of individuals with post-traumatic stress disorder (PTSD).
Transient Adverse Side Effects During Neurofeedback Training: A Randomized, Sham-Controlled, Double Blind Study. [2015]The benefits of clinical neurofeedback training are well known, however, its adverse side-effects are less studied. This research focuses on the transient adverse side effects of neurofeedback training via a double-blind, sham/controlled methodology. Thirty healthy undergraduate students volunteers were randomly divided into three treatment groups: increasing a modified Sensory Motor Rhythm, increasing Upper Alpha, and Sham/control group who receive a random reward. The training sessions were administered for a total of ten sessions. Questionnaires of transient adverse side effects were completed by all volunteers before each session. The results suggest that similar to most medical treatments, neurofeedback can cause transient adverse side effects. Moreover, most participants reported experiencing some side effects. The side effects can be divided into non-specific side effect, associated with the neurofeedback training in general and specific ones associated with the particular protocol. Sensory Motor Rhythm protocol seems to be the most sensitive to side effects.
Effectiveness of neurofeedback therapy for anxiety and stress in adults living with a chronic illness: a systematic review protocol. [2019]The objective of this review is to systematically examine the effectiveness of neurofeedback therapy for managing anxiety and stress in adults living with a chronic illness.The specific objectives are to identify which neurofeedback systems and/or protocols demonstrate effectiveness and determine the level of supporting evidence.The review question is as follows: What is the effectiveness of neurofeedback therapy for managing anxiety and stress in an adult population aged 18 years of age or older living with a chronic illness?
Using connectivity-based real-time fMRI neurofeedback to modulate attentional and resting state networks in people with high trait anxiety. [2021]High levels of trait anxiety are associated with impaired attentional control, changes in brain activity during attentional control tasks and altered network resting state functional connectivity (RSFC). Specifically, dorsolateral prefrontal cortex to anterior cingulate cortex (DLPFC - ACC) functional connectivity, thought to be crucial for effective and efficient attentional control, is reduced in high trait anxious individuals. The current study examined the potential of connectivity-based real-time functional magnetic imaging neurofeedback (rt-fMRI-nf) for enhancing DLPFC - ACC functional connectivity in trait anxious individuals. We specifically tested if changes in DLPFC - ACC connectivity were associated with reduced anxiety levels and improved attentional control. Thirty-two high trait anxious participants were assigned to either an experimental group (EG), undergoing veridical rt-fMRI-nf, or a control group (CG) that received sham (yoked) feedback. RSFC (using resting state fMRI), anxiety levels and Stroop task performance were assessed pre- and post-rt-fMRI-nf training. Post-rt-fMRI-nf training, relative to the CG, the EG showed reduced anxiety levels and increased DLPFC-ACC functional connectivity as well as increased RSFC in the posterior default mode network. Moreover, in the EG, changes in DLPFC - ACC functional connectivity during rt-fMRI-nf training were associated with reduced anxiety levels. However, there were no group differences in Stroop task performance. We conclude that rt-fMRI-nf targeting DLPFC - ACC functional connectivity can alter network connectivity and interactions and is a feasible method for reducing trait anxiety.
The learning effects and curves during high beta down-training neurofeedback for patients with major depressive disorder. [2021]Electroencephalography (EEG) has revealed increased beta activity in patients with comorbid major depressive disorder (MDD) and anxiety symptoms. Negative emotions and high beta activity could be decreased by a high beta down-training neurofeedback (NFB) protocol. The present study utilized three objective parameters - trainability, independence, and interpretability - to validate the effects of high beta down-training sessions.
EEG Neurofeedback for Anxiety Disorders and Post-Traumatic Stress Disorders: A Blueprint for a Promising Brain-Based Therapy. [2021]This review provides an overview of current knowledge and understanding of EEG neurofeedback for anxiety disorders and post-traumatic stress disorders.
Efficacy Evaluation of Neurofeedback-Based Anxiety Relief. [2021]Anxiety disorder is a mental illness that involves extreme fear or worry, which can alter the balance of chemicals in the brain. This change and evaluation of anxiety state are accompanied by a comprehensive treatment procedure. It is well-known that the treatment of anxiety is chiefly based on psychotherapy and drug therapy, and there is no objective standard evaluation. In this paper, the proposed method focuses on examining neural changes to explore the effect of mindfulness regulation in accordance with neurofeedback in patients with anxiety. We designed a closed neurofeedback experiment that includes three stages to adjust the psychological state of the subjects. A total of 34 subjects, 17 with anxiety disorder and 17 healthy, participated in this experiment. Through the three stages of the experiment, electroencephalography (EEG) resting state signal and mindfulness-based EEG signal were recorded. Power spectral density was selected as the evaluation index through the regulation of neurofeedback mindfulness, and repeated analysis of variance (ANOVA) method was used for statistical analysis. The findings of this study reveal that the proposed method has a positive effect on both types of subjects. After mindfulness adjustment, the power map exhibited an upward trend. The increase in the average power of gamma wave indicates the relief of anxiety. The enhancement of the wave power represents an improvement in the subjects' mindfulness ability. At the same time, the results of ANOVA showed that P < 0.05, i.e., the difference was significant. From the aspect of neurophysiological signals, we objectively evaluated the ability of our experiment to relieve anxiety. The neurofeedback mindfulness regulation can effect on the brain activity pattern of anxiety disorder patients.
Sensorimotor rhythm neurofeedback training relieves anxiety in healthy people. [2023]Timely relief of anxiety in healthy people is important, but there is little research on this topic at present. Neurofeedback training allows subjects to regulate their specific brain activities autonomously and thus alter their corresponding cognitive functions. Inattention is a significant cognitive deficit in patients with anxiety. Sensorimotor rhythm (SMR) was reported to be closely related to attention. In this study, trainability, frequency specificity, and brain-behavior relationships were utilized to verify the validity of a relative SMR power protocol. An EEG neurofeedback training system was developed for alleviating anxiety levels in healthy people. The EEG data were collected from 33 subjects during SMR up-training sessions. Subjects attended six times neurofeedback training for about 2 weeks. The feedback value of the neurofeedback group was the relative SMR power at the feedback electrode (electrode C3), while the feedback values for the control group were pseudorandom numbers. The trainability index revealed that the learning trend showed an increase in SMR power activity at the C3 electrode, confirming effects across training. The frequency specificity index revealed only that SMR band activity increased significantly in the neurofeedback group. The brain-behavior relationships index revealed that increased SMR activity correlated negatively with the severity of anxiety. This study indicates that neurofeedback training using a relative SMR power protocol, based on activity at the C3 electrode, could relieve anxiety levels for healthy people and increase the SMR power. Preliminary studies support the feasibility and efficacy of the relative SMR power protocol for healthy people with anxiety.
Heart Rate Variability Biofeedback as Adjunctive Treatment of Generalized Anxiety Disorder: A Case Report. [2023]Generalized anxiety disorder (GAD) is a common psychiatric disorder that can cause significant functional impairment to a patient's life. Mind body therapies (MBT) have increasingly been used as an intervention to manage symptoms of anxiety. Heart rate variability (HRV) biofeedback is a specific MBT that utilizes real-time feedback on autonomic functioning to train the physiological stress response through diaphragmatic breathing.