Neurofeedback Enhanced Cognitive Reappraisal Training - Phase 4

Not Applicable

Active, not recruiting

• Conditions: Generalized Anxiety Disorder; Anxiety; Panic Disorder; Social Anxiety Disorder
• Interventions: Other: Functional magnetic resonance imaging (fMRI) with Veritable-NF; Other: fMRI with Sham-NF

• Registration Number: NCT06563310
• Lead Sponsor: University of Michigan

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-08-19
• Study First Submitted QC: 2024-08-19
• Study First Posted: 2024-08-20
• Study Start: 2025-01-09
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-10
• Primary Completion: 2029-05
• Study Completion: 2029-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Veritable-NF	Functional magnetic resonance imaging (fMRI) with Veritable-NF	-
Sham-NF	fMRI with Sham-NF	-

Primary Outcome Measures

Name	Time	Method
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)	Approximately 60 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Change in amygdala-PFC functional connectivity (baseline to transfer) from reappraise > look contrast	Approximately 60 minutes	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.

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States