N/A
N=21
Neurofeedback Enhanced Cognitive Reappraisal Training
Anxiety · Social Anxiety Disorder · Panic Disorder · Generalized Anxiety Disorder
Bottom Line
View on ClinicalTrials.gov: NCT06132659 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Change in Prefrontal Cortex (PFC) Activity (Baseline to Transfer Run) From the Reappraise > Look Contrast on the Emotion Regulation Task (ERT) — 0.042; 0.019; 0.007 Percent signal change per run
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Functional magnetic resonance imaging (fMRI) with Veritable-NF (Other); fMRI with Sham-NF (Other)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Jul 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Prefrontal Cortex (PFC) Activity (Baseline to Transfer Run) From the Reappraise > Look Contrast on the Emotion Regulation Task (ERT) |
0.042; 0.019; 0.007 | — |
| PRIMARY Difference in Negative Affect Ratings of Images From International Affective Picture System (IAPS) |
0.57; 0.29; 0.03 | — |
| SECONDARY Change in Amygdala-PFC Functional Connectivity (Baseline to Transfer) From Reappraise > Look Contrast |
0; 0; 0 | — |
Summary
This study seeks to understand emotion regulation in those 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 increase 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
* Prefrontal cortex activation will positively correlate with CR ability
Eligibility Criteria
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 the GAD/CROSS-AD composite
- Medically and physically able to consent
- Not regularly taking any medication, prescription or non-prescription, with psychotropic effects other than:
- Buspirone, or antidepressant (e.g., selective serotonin reuptake inhibitor (SSRI) or serotonin-norepinephrine reuptake inhibitor (SNRI)) with stable dosage for past 4 weeks
- Hormonal contraceptives of any type for any duration
- 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
Data sourced from ClinicalTrials.gov (NCT06132659). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.