Neurofeedback for Anxiety Disorders

Overseen By Laura Stchur, MSW

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Must be taking: Buspirone, Antidepressants

Disqualifiers: OCD, PTSD, Bipolar, substance abuse, others

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

Compensation: Varies

Number of Visits: Unknown

14 Participants Needed

Trial Summary

What is the purpose of this trial?

This study seeks to understand emotion regulation in those with anxiety using real-time functional magnetic resonance imaging neurofeedback, a tool that allows individuals to control brain activity. The goal of this project is to understand how receiving feedback about one's own brain activity relates to emotion regulation ability. This work will help the study team understand the brain areas involved in emotion regulation and could lay the groundwork to test if psychotherapy outcomes can be enhanced using neurofeedback. The study hypotheses include: * Participants receiving veritable-Neurofeedback (NF) will show a greater activation increase in the prefrontal cortex (PFC) compared to sham-NF * Participants receiving veritable-NF will show greater cognitive reappraisal (CR) ability compared to those receiving sham-NF * Prefrontal cortex activation will positively correlate with CR ability

Do I have to stop taking my current medications for the trial?

The trial does not specify if you must stop all current medications, but you can continue taking buspirone or antidepressants like SSRIs or SNRIs if your dosage has been stable for the past 4 weeks. Hormonal contraceptives are also allowed.

What data supports the idea that Neurofeedback for Anxiety Disorders is an effective treatment?

The available research shows that Neurofeedback for Anxiety Disorders can be effective. One study found that using neurofeedback during cognitive reappraisal helped reduce activity in the amygdala, a part of the brain involved in emotion processing, which suggests better emotion regulation. Another study showed that neurofeedback helped people with spider phobia manage their anxiety by using cognitive reappraisal, indicating its potential for anxiety disorders. Additionally, neurofeedback has been shown to enhance the effectiveness of cognitive behavioral therapy (CBT) by helping individuals better understand and use CBT strategies in real life. These findings suggest that neurofeedback can be a useful tool in managing anxiety. ^{1 2 3 4 5}

What safety data exists for neurofeedback treatment for anxiety disorders?

The studies reviewed provide evidence that neurofeedback, particularly using real-time functional magnetic resonance imaging (rtfMRI), is a promising treatment for anxiety disorders. The research indicates that neurofeedback can effectively modulate brain activity, such as reducing amygdala response and altering brain connectivity, which are associated with improved emotion regulation and reduced anxiety symptoms. While these studies demonstrate the potential efficacy and lasting effects of neurofeedback, they do not specifically address safety data. However, the absence of reported adverse effects in these studies suggests a favorable safety profile, though more targeted research on safety is needed. ^{1 4 6 7 8}

Is neurofeedback a promising treatment for anxiety disorders?

Yes, neurofeedback is a promising treatment for anxiety disorders. It helps people learn to control brain activity related to anxiety, leading to reduced anxiety levels. Studies show that it can change brain connections and improve emotion regulation, with effects lasting even after the treatment ends. ^{1 4 6 9 10}

Research Team

Stefanie Russman Block

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for individuals with a primary diagnosis of generalized anxiety disorder, social anxiety disorder, panic disorder, or illness anxiety disorder. Participants must be able to consent and tolerate small spaces without anxiety. They should not be on any psychotropic medication except stable antidepressants or birth control, and cannot be pregnant or trying to conceive. No metal implants that affect MRI.

Inclusion Criteria

Your body size fits inside the scanner.

You can have phobic disorders, but they should not be the main reason for your distress or problems during the study.

You can handle being in small, enclosed spaces without feeling too nervous.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neurofeedback Training

Participants undergo neurofeedback training to enhance emotion regulation using real-time fMRI

Approximately 60 minutes per session

Multiple sessions (in-person)

Follow-up

Participants are monitored for changes in emotion regulation and brain activity post-training

4 weeks

Treatment Details

Interventions

• Neurofeedback Enhanced Cognitive Reappraisal Training

Trial Overview The study tests if real-time fMRI neurofeedback (Veritable-NF) can improve emotion regulation in anxious individuals compared to fake feedback (Sham-NF). It measures changes in brain activity and cognitive reappraisal ability—the skill of altering emotional responses by rethinking situations.

Participant Groups

Group I: Veritable-NF Experimental Treatment 1 Intervention

Group II: Sham-NF Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Brain & Behavior Research Foundation

Collaborator

Trials

63

Recruited

2,900+

Findings from Research

Real-time fMRI feedback of lateral prefrontal cortex (LPFC) activity during cognitive reappraisal significantly reduced amygdala activity in participants, suggesting enhanced emotion regulation capabilities.

The study demonstrated that providing feedback on LPFC activity can improve inter-hemispheric functional connectivity, indicating a potential mechanism for optimizing cognitive reappraisal strategies in emotional processing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

fMRI feedback enhances emotion regulation as evidenced by a reduced amygdala response. Sarkheil, P., Zilverstand, A., Kilian-Hütten, N., et al.[2015]

A systematic review of 271 papers identified that psychological factors, particularly attentional variables, motivation, and mood, significantly influence the success of real-time fMRI-based neurofeedback training, which aims to help individuals self-regulate brain activity.

Future research should focus on manipulating these psychological variables and understanding the experiences of non-responders to improve the effectiveness of neurofeedback interventions and develop better selection criteria for participants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of the psychological factors that influence neurofeedback learning outcomes. Kadosh, KC., Staunton, G.[2019]

Using real-time functional magnetic imaging (rt-fMRI) neurofeedback during cognitive behavioral therapy (CBT) helped participants better understand and apply their personalized strategies for managing negative emotions, leading to increased motivation and effectiveness in real-world situations.

Participants who received neurofeedback showed significant improvements in their ratings of strategy efficacy and frequency of use one month later, indicating that this method not only enhanced immediate learning but also had lasting effects on the application of CBT skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Single session real-time fMRI neurofeedback has a lasting impact on cognitive behavioral therapy strategies. MacDuffie, KE., MacInnes, J., Dickerson, KC., et al.[2021]

Real-time functional magnetic resonance imaging neurofeedback (rtfMRI-NF) shows a medium-sized effect on neural activity during training and a large effect on neural activity after training, indicating its potential to influence brain function in psychiatric disorders.

Behavioral outcomes from rtfMRI-NF, such as symptom reduction, show a small effect size, suggesting that while rtfMRI-NF can impact brain activity, its effects on behavior may be less pronounced and require further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of real-time functional magnetic resonance imaging neurofeedback for psychiatric illness: A meta-analysis of brain and behavioral outcomes. Dudek, E., Dodell-Feder, D.[2022]

In a study involving 18 female spider phobics, those who received neurofeedback during cognitive reappraisal training showed significantly lower anxiety levels compared to a control group.

Neurofeedback participants were able to successfully down-regulate activation in the insula, a brain region associated with anxiety, and this change predicted long-term reductions in anxiety, suggesting that neurofeedback can enhance anxiety regulation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

fMRI neurofeedback facilitates anxiety regulation in females with spider phobia. Zilverstand, A., Sorger, B., Sarkheil, P., et al.[2020]

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]

The study developed a new EEG-based neurofeedback method targeting the right inferior frontal gyrus (rIFG), which showed successful engagement of the intended brain region during training, as confirmed by fMRI results from a small group of 14 participants.

After two sessions of this EEG neurofeedback training with 41 participants, individuals demonstrated improved cognitive control by reducing their risk-taking behavior, indicating the method's potential efficacy for enhancing cognitive functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neural and functional validation of fMRI-informed EEG model of right inferior frontal gyrus activity. Or-Borichev, A., Gurevitch, G., Klovatch, I., et al.[2023]

The study demonstrated that healthy participants could effectively down-regulate activity in the right amygdala using real-time functional MRI (rtfMRI) neurofeedback while exposed to negative emotional stimuli, suggesting a potential method for emotion regulation.

This approach, which involved four training sessions with six participants, indicates that rtfMRI neurofeedback could be a promising tool for treating emotional disorders by targeting the overactive amygdala, which is often dysregulated in such conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time neurofeedback using functional MRI could improve down-regulation of amygdala activity during emotional stimulation: a proof-of-concept study. Brühl, AB., Scherpiet, S., Sulzer, J., et al.[2021]

Real-time fMRI can help patients learn to self-regulate brain circuits related to emotion and depression, showing promise as a new approach to treating affective disorders.

Initial results from fMRI-based neurofeedback (fMRI-NF) in depression are encouraging, but further clinical trials are needed to establish its efficacy and to develop practical applications for everyday use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neurofeedback and networks of depression. Linden, DE.[2021]

A study involving 26 healthy participants with high anxiety demonstrated that real-time fMRI neurofeedback training can enhance connectivity between the ventrolateral prefrontal cortex and the amygdala, leading to significant reductions in anxiety levels.

The training not only improved connectivity during the session but also allowed participants to maintain control over this pathway three days later, suggesting a promising new method for managing anxiety through self-regulation of brain circuits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-Time Functional Connectivity-Informed Neurofeedback of Amygdala-Frontal Pathways Reduces Anxiety. Zhao, Z., Yao, S., Li, K., et al.[2019]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

fMRI feedback enhances emotion regulation as evidenced by a reduced amygdala response. [2015]

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

A systematic review of the psychological factors that influence neurofeedback learning outcomes. [2019]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Single session real-time fMRI neurofeedback has a lasting impact on cognitive behavioral therapy strategies. [2021]

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

The efficacy of real-time functional magnetic resonance imaging neurofeedback for psychiatric illness: A meta-analysis of brain and behavioral outcomes. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

fMRI neurofeedback facilitates anxiety regulation in females with spider phobia. [2020]

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

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

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

Neural and functional validation of fMRI-informed EEG model of right inferior frontal gyrus activity. [2023]

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

Real-time neurofeedback using functional MRI could improve down-regulation of amygdala activity during emotional stimulation: a proof-of-concept study. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Neurofeedback and networks of depression. [2021]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Real-Time Functional Connectivity-Informed Neurofeedback of Amygdala-Frontal Pathways Reduces Anxiety. [2019]