Neurofeedback Enhanced Cognitive Reappraisal Training

NCT06132659 | Completed Results

• 1 other identifier: HUM00209563
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Anxiety; Social Anxiety Disorder; Panic Disorder; Generalized Anxiety Disorder

Keywords

functional magnetic resonance imaging

Outcome Measures

Primary Outcomes (2)

• Change in Prefrontal Cortex (PFC) Activity (Baseline to Transfer Run) From the Reappraise > Look Contrast on the Emotion Regulation Task (ERT)

  The PFC was defined in MNI space using significant group level activation in the posterior medical frontal cortex from the reappraise\>look contrast from earlier pilot subjects. Percent signal change in this region was extracted for all participants. Change in PFC activity was calculated as the linear slope of change across all 5 runs of the task. To this end, a linear regression was conducted for each participant separately with "run" as the independent variable and "PFC percent signal change" as the dependent variable to calculate change in percent signal change over time. These slopes were then averaged for each group .

  Approximately 60 minutes

• Difference in Negative Affect Ratings of Images From International Affective Picture System (IAPS)

  The Self-Assessment Manikin (SAM) is a pictorial assessment technique in which a changing manikin figure depicts values along the primary dimension of affective valence (positive/negative). Users may indicate emotional reactions along a scale from 1-9, with higher numbers indicating greater negative affect. After the scan, participants will rate each image they saw along this scale. Differences in SAM ratings from look to reappraise trials (e.g., average reappraise score minus average look score) will be evaluated and compared between sham-NF and veritable-NF groups. Higher difference score indicates that images viewed during reappraisal are seen as more positive than those viewed during the look condition.

  Within 10 minutes of exiting the scanner

Secondary Outcomes (1)

• Change in Amygdala-PFC Functional Connectivity (Baseline to Transfer) From Reappraise > Look Contrast

  Each run is approximately 9 minutes long. Run 5 starts approximately 30 minutes after the completion of run 1.

Study Arms (3)

Veritable-NF (MPC)

EXPERIMENTAL

Other: Functional magnetic resonance imaging (fMRI) with Veritable-NF

Sham-NF

ACTIVE COMPARATOR

Other: fMRI with Sham-NF

Veritable-NF (PFC)

ACTIVE COMPARATOR

Other: Functional magnetic resonance imaging (fMRI) with Veritable-NF

Interventions

Functional magnetic resonance imaging (fMRI) with Veritable-NF OTHER

Participants will have 4 visits (some can be done virtually). The baseline visit will include an interview and questionnaires. Eligible participants will have a practice session at visit 2, and may do a mock scanner if the visit is in person. Visit 3 will take place within 5 days of the practice session and participants will be asked to complete questionnaires and have an fMRI with the real neurofeedback. Visit 4 will take place one month after visit 3 and will include a follow-up interview with a trainer assessor as well as questionnaires. Additionally, 2 weeks after visit 3 participants will also complete some questionnaires online.

Veritable-NF (MPC); Veritable-NF (PFC)

fMRI with Sham-NF OTHER

Participants will have 4 visits (some can be done virtually). The baseline visit will include an interview and questionnaires. Eligible participants will have a practice session at visit 2, and may do a mock scanner if the visit is in person. Visit 3 will take place within 5 days of the practice session and participants will be asked to complete questionnaires and have an fMRI with feedback that looks similar to real neurofeedback, but is computer generated. Visit 4 will take place 2 weeks after visit 3 and participants will complete more questionnaires.

Sham-NF

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Brain & Behavior Research Foundation: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Anxiety Disorders; Phobia, Social; Panic Disorder; Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Mental Disorders; Phobic Disorders

Results Point of Contact

• Title: Dr. Stefanie Russman Block
• Organization: University of Michigan

srblo@umich.edu

734-232-0373

Study Officials

• Stefanie Russman Block, Ph.D

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: (Veritable-NF (MPC) and Sham-NF only): All staff present during the MRI session, as well as the participant, will be blinded to group assignment. A designated member of the study team will remain unblinded during the duration of the study.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor of Psychiatry

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 15, 2023
• Study Start: April 22, 2024
• Primary Completion: July 19, 2025
• Study Completion: July 19, 2025
• Last Updated: December 11, 2025
• Results First Posted: December 11, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)