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)
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;
Completed at least one adequate course of trauma-focused behavioral therapy in the past one (1) year without improvement in PTSD symptoms, as documented in medical records. (Subjects are ineligible if medical records do not show evidence of symptom improvement from the previous trauma focused therapy that had been conducted in the year prior to Screening); Non-response will be determined by clinical judgment and qualitative note content. If PCL-5 or CAPS-5 scores are available within 2 weeks prior to beginning treatment and within 2 weeks post-treatment, an improvement of <10 points in PCL-5 and <10 points in CAPS-5 will be used as a threshold indicating non-response in addition to clinical judgement.
Lifetime diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I or II disorder, psychosis not otherwise specified, or delusional disorder;
Any Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) Mood or anxiety disorder (in addition to those described in the previous exclusion) that is the primary focus of mental health treatment in the 6 months prior to screening, per the site investigator's clinical judgment;
Intellectual disability (known full scale IQ<70) per the site investigator's clinical judgment;
Foundation for Atlanta Veterans Education and Research, Inc.
Lead sponsor
GrayMatters Health Ltd.
Collaborator
Rochester Institute of Technology
Collaborator
NYU Langone Health
Collaborator
Atlanta VA Medical Center
Collaborator
Birmingham VA Health Care System
Collaborator
Ralph H. Johnson VA Medical Center
Collaborator
VA Boston Healthcare System
Collaborator
CTP Inc
Collaborator
BioStats Statistical Consulting Ltd
Collaborator
ShareCRF
Collaborator
United States Department of Defense
Collaborator
University of Rochester
Collaborator