RecruitingNot ApplicableNCT06563310

Neurofeedback Enhanced Cognitive Reappraisal Training - Phase 4

Sponsor

University of Michigan

Enrollment

110 participants

Start Date

Jan 9, 2025

Study Type

INTERVENTIONAL

Conditions

Anxiety Social Anxiety Disorder Generalized Anxiety Disorder Panic Disorder

Summary

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

Eligibility

Min Age: 18 YearsMax Age: 24 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a brain-training program that combines neurofeedback (real-time brain activity feedback during an MRI scan) with cognitive reappraisal training — a technique that teaches you to reframe anxious thoughts — to see if it helps reduce anxiety disorders. **You may be eligible if...** - You have been diagnosed with generalized anxiety disorder, social anxiety disorder, panic disorder, or illness anxiety disorder - You score moderate or higher on an anxiety screening questionnaire - You are able to lie in a small, enclosed MRI scanner without anxiety - You have no metal implants or devices in your body - You are not pregnant and not trying to become pregnant (if female) - You are not taking any mind-affecting medications, except stable doses of antidepressants (SSRIs/SNRIs) or buspirone for at least 4 weeks **You may NOT be eligible if...** - You have OCD, PTSD, or Bipolar Disorder - You have had a substance abuse or dependence problem in the past 6 months - You have active thoughts of suicide with a plan or intent - You currently have psychosis - You have a serious neurological illness or significant brain injury history (e.g., loss of consciousness for more than 5 minutes) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERFunctional magnetic resonance imaging (fMRI) with Veritable-NF

Participants will complete 4 visits (some can be done virtually). The baseline visit will include a clinical interview. Eligible participants will complete a series of questionnaires and a practice session at visit 2, and may do a mock scan if the visit is in person. Visit 3 will take place within 5 days of the practice session. Participants will have an fMRI with real neurofeedback and answer a series of questions pertaining to the scan. 2 weeks after visit 3, participants will revisit the questionnaires they completed at baseline. Visit 4 will take place one month after visit 3 and will include a follow-up interview with an assessor and the final questionnaire collection.

OTHERfMRI with Sham-NF

Participants will complete 4 visits (some can be done virtually). The baseline visit will include a clinical interview. Eligible participants will complete a series of questionnaires and a practice session at visit 2, and may do a mock scan if the visit is in person. Visit 3 will take place within 5 days of the practice session. Participants will have an fMRI with neurofeedback that looks similar to real neurofeedback but does not reflect their true brain signal. Afterwards, they will answer a series of questions pertaining to the scan. 2 weeks after visit 3, participants will revisit the questionnaires they completed at baseline. Visit 4 will take place one month after visit 3 and will include a follow-up interview with an assessor and the final questionnaire collection.