Recruiting

Neurofeedback

Sponsor:

University of Michigan

Code:

NCT06563310

Conditions

Anxiety

Social Anxiety Disorder

Panic Disorder

Generalized Anxiety Disorder

Eligibility Criteria

Sex: All

Age: 18 - 24

Healthy Volunteers: Not accepted

Interventions

Functional magnetic resonance imaging (fMRI) with Veritable-NF

fMRI with Sham-NF

Study Details

Brief 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

Conditions

Anxiety

Social Anxiety Disorder

Panic Disorder

Generalized Anxiety Disorder

Study ID

NCT06563310

Start date

Jan 9, 2025

Status verified date

Jun, 2026

Completion date

May, 2029

Anticipated

Primary completion date

May, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 24

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Primary diagnosis (primary source of distress and/or interference) of generalized anxiety disorder, social anxiety disorder, panic disorder or illness anxiety disorder based on structured interview. Comorbid phobic disorders allowed, but these cannot be the primary source of interference or distress due to the lowered chances of encountering anxiety-provoking stimuli during the study period
  • Score of 2 or more on at least 1 question from GAD/CROSS-AD composite
  • Medically and physically able to consent
  • Not regularly taking any medication, prescription or non-prescription, with psychotropic effects other than:

1. Buspirone, or antidepressant (e.g., selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)) with stable dosage for past 4 weeks
2. The same oral hormonal contraceptive for at least 3 months
  • For females, not currently pregnant or actively trying to become pregnant
  • Ability to tolerate small, enclosed spaces without anxiety
  • No metals, implants or metallic substances within or on the body that might cause adverse effects to the subject in a strong magnetic field, or interfere with image acquisition (per protocol)
  • Size compatible with scanner gantry (per protocol)

Exclusion Criteria:

  • Current diagnosis of Obsessive Compulsive Disorder, Posttraumatic Stress Disorder, or Bipolar Disorder
  • Current substance abuse or dependence (past 6 months)
  • Active suicidality with plan or intent
  • Current psychosis
  • History of serious neurological illness or current medical condition that could compromise brain function, such as liver failure
  • History of closed head injury, e.g., loss of consciousness greater (>) approximately (\~) 5 minutes, hospitalization, neurological sequela

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Veritable-NF

active comparator: Sham-NF

Interventions

Functional 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.

fMRI 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.

Primary outcome measure

  • Change in prefrontal cortex (PFC) activity (baseline to transfer run) from the reappraise > look contrast [ Time Frame: Approximately 60 minutes ]
  • Change in negative affect ratings of images from the International Affective Picture System (IAPS) [ Time Frame: Approximately 60 minutes ]

Central Contacts and Locations

Central contacts

Sophia Hovakimian

734-232-0129shovakim@med.umich.edu

Laura Stchur, MSW

734-936-1323lmarine@med.umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Sophia Hovakimian

734-232-0129shovakim@med.umich.edu

Principal Investigator:

Stefanie Russman Block, Ph.D

More Information

Sponsor

University of Michigan

Last update posted

Jun 5, 2026

Last verified

Jun, 2026

Keywords

  • functional magnetic resonance imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-06-05.