Neurofeedback of Amygdala Activity for Post-traumatic Stress Disorder

Not Applicable

Terminated

Brief Summary: The primary purpose of this study is to investigate the efficacy of neurofeedback (NF) of real-time functional magnetic resonance imaging (rt-fMRI) data of the amygdala with regards to the reduction of post-traumatic stress disorder (PTSD) symptoms.

A secondary purpose of this study is to use fMRI as a method of investigating brain function in individuals with PTSD. This study approach provides a tool for probing the neurobiology of PTSD by (1) testing the critical role of the amygdala in this disorder, and by (2) examining how amygdala connectivity is related to both amygdala regulation and clinical symptoms.

Detailed Description: In pursuit of the overarching goals of this study, the investigators aim to:

* determine if an experimental feedback intervention increases control over the region of interest (the amygdala) more than a control feedback intervention in which participants receive feedback that is unassociated with their PTSD symptoms.

* determine if an experimental feedback intervention results in clinical improvements in PTSD symptoms relative to a control feedback intervention, and examine whether these improvements correlate with improved control over the amygdala.

* determine if an experimental feedback intervention results in changes in resting state connectivity to the amygdala, and whether these changes correlate with symptom improvement and an improved ability to regulate the amygdala.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Experimental Feedback Intervention	Experimental Feedback	Participants receive real-time feedback during fMRI scans that the investigators believe may help them learn to control their PTSD symptoms.
Control Feedback Intervention	Control Feedback	Participants receive real-time feedback during fMRI scans that the investigators do not believe can help their PTSD symptoms.

Primary Outcome Measures

Name	Time	Method
Change in Control Over the Amygdala	baseline; 30 day-day follow up	Control over the amygdala will be defined as the change in the blood-oxygen-level dependent (BOLD) signal in the target area (an individually-localized region of interest (ROI) in the amygdala) during down-regulation blocks following symptom provocation relative to rest. Investigators will assess the magnitude of change in control over the amygdala to trauma reminders from baseline to 30-day post treatment follow-up. This measure is based on beta values, which are unitless

Secondary Outcome Measures

Name	Time	Method
Improvements in PTSD Symptoms	Baseline; 60-day follow-up	Clinical improvement will be defined as the change from baseline at the post-intervention assessments (based on the past-month Clinician-Administered PTSD scale for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V ) \[CAPS-5\]). Score ranges from 0 - no PTSD symptoms to a maximum of 80. Higher score is associated with increase severity of PTSD. A change in CAPS score of more than 5 points over the course of treatment is considered a meaningful change and a change of 10 point or more is considered to be a clinically meaningful change.
Number of Participants With Changes in Resting State Connectivity to the Amygdala	Baseline; 60 days follow up.	The number of participants with a significant whole brain change in seed region connectivity to the amygdala from pre- to post-intervention will be assessed in the blood-oxygen-level dependent (BOLD) signal collected during resting state runs.

Locations (2): VA Connecticut Healthcare System - West Haven Campus
🇺🇸
West Haven, Connecticut, United States
Yale School of Medicine
🇺🇸
New Haven, Connecticut, United States