Neurofeedback Enhanced Cognitive Reappraisal Training - Phase 4

NCT06563310 | Recruiting

• 2 other identifiers: HUM00209563 - phase 41K23MH133063-01A1
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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

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

  Approximately 60 minutes

• Change in negative affect ratings of images from the 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 from the IAPS along this scale. Differences in SAM ratings from look to reappraise trials will be evaluated and compared between sham-NF and veritable-NF groups.

  Approximately 60 minutes

Secondary Outcomes (1)

• Change in amygdala-PFC functional connectivity (baseline to transfer) from reappraise > look contrast

  Approximately 60 minutes

Study Arms (2)

Veritable-NF

EXPERIMENTAL

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

Sham-NF

ACTIVE COMPARATOR

Other: fMRI with Sham-NF

Interventions

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

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.

Veritable-NF

fMRI with Sham-NF OTHER

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.

Sham-NF

Eligibility Criteria

• Age: 18 Years - 24 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 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
• 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)

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
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Mental Disorders; Phobic Disorders

Study Officials

• Stefanie Russman Block, Ph.D

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophia Hovakimian

CONTACT

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

Laura Stchur, MSW

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• 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: August 19, 2024
• First Posted: August 20, 2024
• Study Start: January 9, 2025
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)