A Prospective Randomized Study of a Novel EEG Neurofeedback System for the Treatment of PTSD Using Machine Learning-Based Amygdala Biomarkers
The goal of this clinical trial is to learn if training with the Prism system can reduce PTSD symptoms in US military Veterans and civilians with PTSD. Prism is a form of neurofeedback training that uses EEG signals to promote self-regulation of brain function. The main question this study aims to answer is: Does Prism training lead to decreased PTSD symptoms in US Veterans and civilians when used in addition to usual PTSD treatment? Researchers will compare Prism training to a sham training (a look-alike training that does not provide real feedback on brain activity) to see if Prism training decreases PTSD symptoms. Participants will: * Complete two one-hour in-person training sessions a week for about 8 weeks (15 sessions) * Complete two booster training sessions one month and two months after finishing the main training course * Participate in three detailed interviews: one before training, a second after nine weeks of training, and a third one month after the last booster training session (about 20 weeks after the initial visit)
∙ Subjects must meet the following inclusion criteria:
• Ages 18 to 65 (older limit to avoid those with potentially reduced brain plasticity due to age);
• Male, female, and gender-nonconforming subjects will be allowed. Sites will make efforts to enroll both male and female subjects in roughly equal proportions;
• Diagnosis of PTSD comorbidities will be confirmed by clinical chart review and structured interview with the Diagnostic Interview for Anxiety, Mood, and Obsessive-compulsive and Related Neuropsychiatric Disorders (DIAMOND), a semi-structured diagnostic interview instrument for DSM-5 psychiatric disorders with good test-retest reliability (Tolin et al. 2018);
• Diagnosis of PTSD based on CAPS-5-R (scored as CAPS-5) total score with a minimum severity score of 26 at Baseline in the CAPS-5 score;
• 1-26 years from index trauma;
• Ability to give signed informed consent according to the judgment of the site investigator;
• Normal or corrected-to-normal vision of at least 20/30 as per eye chart screening;
• Normal or corrected-to-normal hearing as per subject report and interview with study staff;
• Willingness and ability to adhere to the study schedule;
⁃ Comorbid major depression will be allowed as long as the primary care is PTSD, because it is frequently comorbid with PTSD, and its inclusion will render our study results salient to the real-world clinical population;\*
⁃ Any psychotropic medication must have been at a stable dose for at least 4 weeks prior to screening;
⁃ At the time of recruitment, patients must have no plan of changing their medication or psychotherapy during the study duration if applicable (subjects will only be dropped if significant psychotropic medication changes happen as a result of clinical instability that, in the opinion of the principal investigator (PI), would jeopardize their ability to learn or participate).
‣ Note: This is a clarification that comorbid depression is allowed and not an inclusion requirement.