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| Name | Class |
|---|---|
| Brain & Behavior Research Foundation | OTHER |
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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:
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".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Veritable-NF (MPC) | Experimental |
| |
| Sham-NF | Active Comparator |
| |
| Veritable-NF (PFC) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Stefanie Russman Block, Ph.D | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Veritable-NF (MPC) | Functional magnetic resonance imaging (fMRI) with Veritable-NF: 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. |
| FG001 | Sham-NF | fMRI with Sham-NF: 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. |
| FG002 | Veritable-NF (PFC) | Functional magnetic resonance imaging (fMRI) with Veritable-NF: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Veritable-NF (MPC) | Functional magnetic resonance imaging (fMRI) with Veritable-NF: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 . | 1 participant in the sham group had too much motion during the neurofeedback runs of the scans to be included in the analysis. | Posted | Mean | Standard Deviation | Percent signal change per run | Approximately 60 minutes |
|
One month
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Veritable-NF (MPC) | Functional magnetic resonance imaging (fMRI) with Veritable-NF: 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Foot abscess | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Participant presented to the emergency room for foot abscess after consent, but prior to the MRI portion of the study. This adverse event was unrelated to the study intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stefanie Russman Block | University of Michigan | 734-232-0373 | srblo@umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 21, 2025 | Oct 28, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D000072861 | Phobia, Social |
| D016584 | Panic Disorder |
| D000098647 | Generalized Anxiety Disorder |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D010698 | Phobic Disorders |
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(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.
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| 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. |
|
| Each run is approximately 9 minutes long. Run 5 starts approximately 30 minutes after the completion of run 1. |
| BG001 | Sham-NF | fMRI with Sham-NF: 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. |
| BG002 | Veritable-NF (PFC) | Functional magnetic resonance imaging (fMRI) with Veritable-NF: 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hamilton Anxiety Rating Scale | Total score is reported. Scores range from 0-56 and higher scores represent greater anxiety symptoms severity. | Mean | Standard Deviation | score on a scale |
|
| Veritable-NF (MPC) |
Functional magnetic resonance imaging (fMRI) with Veritable-NF: 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. |
| OG001 | Sham-NF | fMRI with Sham-NF: 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. |
| OG002 | Veritable-NF (PFC) | Functional magnetic resonance imaging (fMRI) with Veritable-NF: 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. |
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Within 10 minutes of exiting the scanner |
|
|
|
| Secondary | 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. | 1 participant in the sham group had too much motion during the neurofeedback runs of the scans to be included in the analysis. | Posted | Number | Number of significant voxels in the PFC | Each run is approximately 9 minutes long. Run 5 starts approximately 30 minutes after the completion of run 1. |
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| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Sham-NF | fMRI with Sham-NF: 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. | 0 | 6 | 0 | 6 | 1 | 6 |
| EG002 | Veritable-NF (PFC) | Functional magnetic resonance imaging (fMRI) with Veritable-NF: 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. | 0 | 8 | 0 | 8 | 0 | 8 |
|
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