Neurofeedback Enhanced Cognitive Reappraisal Training - Phase 4

Last updated: June 5, 2025
Sponsor: University of Michigan
Overall Status: Active - Recruiting

Phase

N/A

Condition

Social Phobia

Anxiety Disorders

Mood Disorders

Treatment

fMRI with Sham-NF

Functional magnetic resonance imaging (fMRI) with Veritable-NF

Clinical Study ID

NCT06563310
HUM00209563 - phase 4
1K23MH133063-01A1
  • Ages 18-24
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Primary diagnosis (primary source of distress and/or interference) of generalizedanxiety disorder, social anxiety disorder, panic disorder or illness anxietydisorder based on structured interview. Comorbid phobic disorders allowed, but thesecannot be the primary source of interference or distress due to the lowered chancesof 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, withpsychotropic effects other than:

  1. Buspirone, or antidepressant (e.g., selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)) with stabledosage 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 causeadverse effects to the subject in a strong magnetic field, or interfere with imageacquisition (per protocol)

  • Size compatible with scanner gantry (per protocol)

Exclusion

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 couldcompromise 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

Total Participants: 110
Treatment Group(s): 2
Primary Treatment: fMRI with Sham-NF
Phase:
Study Start date:
January 09, 2025
Estimated Completion Date:
May 31, 2029

Connect with a study center

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Active - Recruiting

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