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

18 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore how controlling brain activity with neurofeedback can help manage anxiety. Participants will receive feedback about their brain activity while using cognitive reappraisal (rethinking negative thoughts) to see if it improves emotion control. The study compares real neurofeedback to a fake version to determine which works better. It seeks individuals with anxiety disorders such as generalized anxiety, social anxiety, or panic disorder who aren't regularly taking certain medications and can handle being in an MRI machine.

As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in anxiety management.

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 prior data suggests that neurofeedback is safe for anxiety disorders?

Research shows that neurofeedback, a method that helps individuals control their brain activity using real-time brain scans, is generally safe. Studies have found that combining neurofeedback with cognitive reappraisal training—a technique to change thought patterns about a situation—can lower the brain's stress response in conditions like anxiety and PTSD (post-traumatic stress disorder).

Participants in these studies did not report any serious side effects. Some individuals might feel a bit uncomfortable in an fMRI machine, a large, loud device that takes pictures of the brain. However, the treatment itself is well-tolerated.

Overall, neurofeedback combined with cognitive reappraisal training is considered safe. It has been used in other studies, providing a reassuring track record for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Neurofeedback Enhanced Cognitive Reappraisal Training for anxiety disorders because it offers a novel approach compared to traditional treatments like medication and talk therapy. Most current treatments focus on managing symptoms, while this technique uses real-time brain activity feedback to help individuals directly regulate their emotional responses. This method empowers patients to actively participate in their own mental health management by retraining their brain patterns, potentially leading to more lasting and personalized improvements.

What evidence suggests that neurofeedback is effective for anxiety?

Research shows that neurofeedback, a method monitoring brain activity in real-time, can help people with anxiety manage their emotions more effectively. This trial will compare different neurofeedback approaches. Participants in the Veritable-NF (MPC) arm will receive neurofeedback targeting the motor cortex, while those in the Veritable-NF (PFC) arm will focus on the prefrontal cortex, which plays a key role in controlling emotions. Studies have found that neurofeedback can alter brain activity in areas like the prefrontal cortex. Specifically, neurofeedback is linked to reduced activity in the amygdala, a part of the brain associated with stress and anxiety. This change in brain activity often leads to better emotional control and fewer anxiety symptoms. Early findings suggest that participants in neurofeedback training may see improvements in managing their anxiety. ^{1 2 3 4 6}

Who Is on the Research Team?

Stefanie Russman Block

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

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

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

Your body size fits inside the scanner.

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Veritable-NF (MPC) Experimental Treatment 1 Intervention

Group II: Sham-NF Active Control 1 Intervention

Group III: Veritable-NF (PFC) 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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06563310

Study Details | NCT06563310 | Neurofeedback Enhanced ... This study seeks to understand emotion regulation in those with young adults with anxiety using real-time functional magnetic resonance imaging ...

2. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2021.715898/full

fMRI Neurofeedback-Enhanced Cognitive Reappraisal ... Rt-fMRI neurofeedback-guided cognitive reappraisal training modulates amygdala responsivity in posttraumatic stress disorder. NeuroImage ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8419460/

A Double-Blind Comparison of Left and Right vlPFC Regulation Rt-fMRI neurofeedback-guided cognitive reappraisal training modulates amygdala responsivity in posttraumatic stress disorder. NeuroImage Clin. (2020) 28 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S221315822030320X

Rt-fMRI neurofeedback-guided cognitive reappraisal ... Our findings suggest beneficial effects of the NF training indicated by reduced amygdala responses that were associated with improved symptom severity and ...

5. withpower.com withpower.com/trial/phase-anxiety-disorders-1-2024-1e188

Neurofeedback for Anxiety Disorders This study seeks to understand emotion regulation in those with anxiety using real-time functional magnetic resonance imaging neurofeedback, ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S1053811925000813

fNIRS neurofeedback facilitates emotion regulation This study provides novel causal evidence that VLPFC single bond NF training can effectively enhance emotion regulation, highlighting the importance of ...