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 study seeks to understand emotion regulation in those with young adults 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 increases 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 * PFC activation will positively correlate with CR ability

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.

Is neurofeedback safe for humans?

Neurofeedback, including methods like real-time functional MRI, has been used safely in studies to help regulate brain activity related to emotions and anxiety. These studies have shown that neurofeedback can change brain connectivity and activity without reported adverse effects, suggesting it is generally safe for humans. ^{1 2 3 4 5}

How is Neurofeedback Enhanced Cognitive Reappraisal Training different from other anxiety treatments?

This treatment is unique because it uses real-time brain activity feedback to help patients learn to control specific brain regions involved in anxiety, potentially leading to lasting changes in brain connectivity and improved anxiety regulation. Unlike traditional therapies, it combines neurofeedback with cognitive reappraisal, a strategy to change negative thought patterns, enhancing its effectiveness. ^{1 2 3 6 7}

What data supports the effectiveness of the treatment Neurofeedback Enhanced Cognitive Reappraisal Training for anxiety?

Research shows that real-time fMRI neurofeedback can help people better control their emotions by reducing activity in the amygdala, a part of the brain involved in emotion processing. Additionally, neurofeedback has been shown to help people with anxiety disorders, like spider phobia, by improving their ability to manage fear through cognitive reappraisal, which involves changing how they think about a situation. ^{1 2 7 8 9}

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

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

Size compatible with scanner gantry

I am mentally and physically capable of giving consent.

Exclusion Criteria

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

Current substance abuse or dependence within the past 6 months

I have been diagnosed with OCD or PTSD.

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

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]

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]

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]

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]

Citations

1. 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]

2. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

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

4. Netherlands pubmed.ncbi.nlm.nih.gov

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

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. Switzerland pubmed.ncbi.nlm.nih.gov

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