Neurofeedback Enhanced Cognitive Reappraisal Training - Phase 4
NCT Number: NCT06563310
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Anxiety|Social Anxiety Disorder|Panic Disorder|Generalized Anxiety Disorder
Interventions: OTHER: Functional magnetic resonance imaging (fMRI) with Veritable-NF|OTHER: fMRI with Sham-NF
Sponsor: University of Michigan
Collaborators: National Institute of Mental Health (NIMH)
Sex: ALL
Age: ADULT
Enrollment: 110
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, CARE_PROVIDER)|Primary Purpose: BASIC_SCIENCE
Start Date: 2024-11
Completion Date: 2029-05
Locations: University of Michigan, Ann Arbor, Michigan, 48109, United States

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 ventrolateral prefrontal cortex (vlPFC) compared to sham-NF
* Participants receiving veritable-NF will show greater cognitive reappraisal (CR) ability compared to those receiving sham-NF
* vlPFC activation will positively correlate with CR ability

Primary Outcome Measures: Change in ventrolateral prefrontal cortex (vlPFC) 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 Outcome Measures: Change in amygdala-vlPFC 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, Neruofeedback1 (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., Approximately 60 minutes