AnxietyNCT06132659
Neurofeedback Enhanced Cognitive Reappraisal Training
A study testing Functional magnetic resonance imaging (fMRI) with Veritable-NF in people with Anxiety and Social Anxiety Disorder, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Anxiety, Social Anxiety Disorder, Panic Disorder
- What is being tested?
- Functional magnetic resonance imaging (fMRI) with Veritable-NF
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Apr 2024to 19 Jul 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the detailed description
Due to an unforeseen error in our online neurofeedback script, in which the location of the brain region being targeted was not properly read by the script, participants in the veritable-NF group received feedback to the medial parietal cortex (MPC) instead of the PFC. A third, unrandomized arm has been added to this registration to enroll an additional subset of participants who are indeed receiving feedback to the PFC. The pre-existing veritable-NF arm has been relabeled to reflect which region of the brain was actually targeted. Additionally, the masking description has been reset to "None".
- Being tested
- Functional magnetic resonance imaging (fMRI) with Veritable-NF, fMRI with Sham-NF
- Keywords
- functional magnetic resonance imaging
- Medical subject headings
- Anxiety Disorders, Phobia, Social, Panic Disorder, Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional magnetic resonance imaging (fMRI) with Veritable-NFOther
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.
fMRI with Sham-NFOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Veritable-NF (MPC) | Experimental | Not described Receives: Other: Functional magnetic resonance imaging (fMRI) with Veritable-NF |
| Sham-NF | Active comparator | Not described Receives: Other: fMRI with Sham-NF |
| Veritable-NF (PFC) | Active comparator | Not described Receives: Other: Functional magnetic resonance imaging (fMRI) with Veritable-NF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: 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.
Measured: Within 10 minutes of exiting the scanner
Secondary outcomes (1)
Change in Amygdala-PFC Functional Connectivity (Baseline to Transfer) From Reappraise > Look Contrast
To examine amygdala connectivity, the study team will use a psychophysiological interaction analysis. Deconvolved time series from anatomical left and right amygdala seeds for each participant will be multiplied by a vector for the reappraise > look contrast at each run (baseline, neurofeedback (NF1, NF2, NF3), transfer). Regressors for the seed time series, the original condition and the interaction term will be convolved with the canonical hemodynamic response function. Change in connectivity from pre-to-post training will be calculated by subtracting the baseline-run contrast map from the transfer-run contrast map. Resulting contrast maps will be entered into second-level random effects analyses in the software SPM, where voxels in the PFC will be examined at p<0.05 FWE-corrected threshold.
Measured: Each run is approximately 9 minutes long. Run 5 starts approximately 30 minutes after the completion of run 1.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2023
- Study start22 Apr 2024
- Primary completion19 Jul 2025
- Study completion19 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Brain & Behavior Research Foundation
- Responsible party
- Principal investigator, Stefanie Russman Block, University of Michigan
- Investigators
- Stefanie Russman Block, Ph.D, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06132659
- Sponsor's protocol ID
- HUM00209563
- Status last verified
- Nov 2025
- First submitted
- 9 Nov 2023
- Last updated
- 11 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurofeedback Enhanced Cognitive Reappraisal Training
- ClinicalTrials.gov ID
- NCT06132659
- Acronym / sponsor ID
- HUM00209563
- Keywords
- functional magnetic resonance imaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Brain & Behavior Research Foundation
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 19 Jul 2025 (actual)
- Study completion
- 19 Jul 2025 (actual)
- First posted
- 15 Nov 2023 (actual)
- Results
- Posted 11 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Due to an unforeseen error in our online neurofeedback script, in which the location of the brain region being targeted was not properly read by the script, participants in the veritable-NF group received feedback to the medial parietal cortex (MPC) instead of the PFC. A third, unrandomized arm has been added to this registration to enroll an additional subset of participants who are indeed receiving feedback to the PFC. The pre-existing veritable-NF arm has been relabeled to reflect which region of the brain was actually targeted. Additionally, the masking description has been reset to "None".
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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:
- For females, not currently pregnant or actively trying to become pregnant
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional magnetic resonance imaging (fMRI) with Veritable-NFParticipants 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. | Other | Veritable-NF (MPC), Veritable-NF (PFC) |
| fMRI with Sham-NFParticipants 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. | Other | Sham-NF |
Primary outcome
Change in Prefrontal Cortex (PFC) Activity (Baseline to Transfer Run) From the Reappraise > Look Contrast on the Emotion Regulation Task (ERT)
Time frame: Approximately 60 minutes
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 .
Difference in Negative Affect Ratings of Images From International Affective Picture System (IAPS)
Time frame: Within 10 minutes of exiting the scanner
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.
1 secondary outcome
Change in Amygdala-PFC Functional Connectivity (Baseline to Transfer) From Reappraise > Look Contrast
Time frame: Each run is approximately 9 minutes long. Run 5 starts approximately 30 minutes after the completion of run 1.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefanie Russman Block, Ph.D principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional magnetic resonance imaging (fMRI) with Veritable-NF in people with Anxiety and Social Anxiety Disorder, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Prefrontal Cortex (PFC) Activity (Baseline to Transfer Run) From the Reappraise > Look Contrast on the Emotion Regulation Task (ERT) (time frame: Approximately 60 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025; AzTrials last refreshed its copy on 1 Nov 2026.