Neurofeedback for Anxiety

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, Psychosis, others

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

Compensation: Varies

Number of Visits: Unknown

110 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a technique called neurofeedback, which allows individuals to observe and control their own brain activity to help manage anxiety. Researchers aim to determine if this method can enhance emotion regulation by comparing real neurofeedback to a placebo version. The study seeks young adults experiencing significant anxiety from conditions such as generalized anxiety, social anxiety, or panic disorder, who are not regularly taking medications that affect the mind.

As an unphased trial, this study offers participants the chance to contribute to innovative research that could lead to new anxiety management techniques.

Will I have to stop taking my current medications?

The trial requires that participants are not regularly taking any medication with psychotropic effects, except for Buspirone or certain antidepressants like SSRIs or SNRIs, if the dosage has been stable for the past 4 weeks. If you are on other medications, you may need to stop them to participate.

What prior data suggests that this neurofeedback technique is safe for young adults with anxiety?

Research has shown that neurofeedback, a technique providing real-time information about brain activity, is generally well-tolerated. Studies with healthy individuals have demonstrated improvements in emotion control without major safety concerns.

One study found that using real-time brain imaging (fMRI) for neurofeedback did not cause significant side effects and even improved emotion control, indicating safety for participants.

Although specific safety data for neurofeedback in individuals with anxiety is lacking, the absence of reported side effects in similar studies suggests it is safe. Discussing any concerns with a healthcare provider before joining a trial is always advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Neurofeedback Enhanced Cognitive Reappraisal Training for anxiety because it offers a unique approach compared to traditional treatments like medication and talk therapy. Unlike standard treatments that focus on altering brain chemistry or cognitive patterns through verbal therapy, this method uses neurofeedback to help patients learn to regulate their brain activity in real-time. By directly targeting and modifying brain wave patterns associated with anxiety, it provides a more personalized and potentially faster way to manage symptoms. This innovative technique could empower individuals to gain better control over their anxiety with potentially fewer side effects than medication.

What evidence suggests that neurofeedback is effective for anxiety?

This trial will compare two approaches: Veritable Neurofeedback (Veritable-NF) and Sham Neurofeedback (Sham-NF). Research has shown that Neurofeedback Enhanced Cognitive Reappraisal Training, which participants in the Veritable-NF arm will receive, helps manage anxiety by teaching control over brain activity. Studies have found that using real-time brain scans can increase activity in the prefrontal cortex, a brain region crucial for decision-making and emotion regulation. This training links to improved cognitive reappraisal, which involves changing thoughts about situations to alter their emotional impact. Early findings also suggest that this method can reduce activity in the amygdala, a brain area involved in stress and emotions, leading to improved mood and fewer anxiety symptoms. Overall, these results suggest that neurofeedback can enhance emotional control and reduce anxiety. ^{1 2 3 6 7}

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 young adults with anxiety disorders such as social anxiety, generalized anxiety, and panic disorder. Participants should be interested in using neurofeedback to potentially improve emotion regulation.

Inclusion Criteria

Size compatible with scanner gantry

I am not on any psychotropic drugs except for birth control or stable antidepressants.

Not currently pregnant or actively trying to become pregnant (for females)

Exclusion Criteria

Current substance abuse or dependence within the past 6 months

I am currently in therapy, either one-on-one or in a group.

Current psychosis

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 control brain activity and improve emotion regulation

Approximately 60 minutes per session

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 feedback on brain activity (veritable-Neurofeedback) can enhance cognitive reappraisal ability better than sham Neurofeedback (placebo). It uses fMRI to monitor changes in the ventrolateral prefrontal cortex.

How Is the Trial Designed?

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+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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 ... fMRI Neurofeedback-Enhanced Cognitive Reappraisal Training in Depression: A Double-Blind Comparison of Left and Right vlPFC Regulation.

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

A Double-Blind Comparison of Left and Right vlPFC Regulation A recent study by (8) has shown that even a single session of real-time functional magnetic imaging neurofeedback (rtfMRI-NF) could enhance the transfer of ...

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7689411/

Rt-fMRI neurofeedback-guided cognitive reappraisal training ... We found neurofeedback-specific attenuation of amygdala responses. Trauma symptoms and the affective state improved in patients at one-month follow-up.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06866028

Enhancing Emotion Regulation Through Functional Near- ... It is hypothesized that combining real-time fNIRS neurofeedback and cognitive reappraisal training will enhance emotion regulation in healthy individuals:.

7. 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, ...