Neurofeedback Enhanced Cognitive Reappraisal Training - Phase 4

NCT ID: NCT06563310

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-09
• Study Completion Date: 2029-05-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Veritable-NF

Group Type: EXPERIMENTAL

Functional magnetic resonance imaging (fMRI) with Veritable-NF

Intervention Type: 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.

Sham-NF

Group Type: ACTIVE_COMPARATOR

fMRI with Sham-NF

Intervention Type: 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.

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Stefanie Russman Block

Clinical Assistant Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stefanie Russman Block, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sophia Hovakimian

Role: CONTACT

shovakim@med.umich.edu

734-232-0129

Laura Stchur, MSW

Role: CONTACT

lmarine@med.umich.edu

734-936-1323

Facility Contacts

Sophia Hovakimian

Role: primary

shovakim@med.umich.edu

734-232-0129

Other Identifiers

1K23MH133063-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HUM00209563 - phase 4

Identifier Type: -

Identifier Source: org_study_id