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;
Parallel
EEG-neurofeedback training
Device15 training sessions (twice/week) plus two booster training sessions added to treatment as usual.
Sham training
Device15 sham sessions (twice/week) plus two sham booster sessions added to treatment as usual.
Total CAPS-5-R score change from Baseline to Week 9
Participants will take the Clinician-Administered PTSD Scale for DSM-5 Revised (the CAPS-5-R) before beginning Prism training. The CAPS-5-R assesses PTSD symptom severity with total scores that range from 0-80, with higher scores indicating more severe symptoms. There are multiple ways to score the CAPS-5-R; this study will score the CAPS-5-R using the same 0-80 score range used on the CAPS-5 (the previous version of the same assessment) so that the results from this study can be more easily compared to results from previous studies on the Prism training system. Participants' scores on the CAPS-5-R after completing training will be compared to their pre-training scores to determine whether the Prism training group shows a greater reduction in PTSD symptoms than the Sham training group.
Total CAPS-5-R score change from Baseline to Week 20
Participants will take the Clinician-Administered PTSD Scale for DSM-5 Revised (the CAPS-5-R) before beginning Prism training. The CAPS-5-R assesses PTSD symptom severity with total scores that range from 0-80, with higher scores indicating more severe symptoms. There are multiple ways to score the CAPS-5-R; this study will score the CAPS-5-R using the same 0-80 score range used on the CAPS-5 (the previous version of the same assessment) so that the results from this study can be more easily compared to results from previous studies on the Prism training system. Scores on the CAPS-5-R at 20 weeks after the first assessment (about one month after the second booster session) will be compared to the baseline CAPS-5-R score to determine whether the changes due to Prism training in the Prism training group vs the Sham training group persist over time.
Exploratory outcome: change in PCL-5 score from Baseline to Week 9 and from Baseline to Week 20
Determine whether PTSD symptoms as measured by the PTSD Checklist for DSM-5 (PCL-5) decrease from Baseline to Week 9 and from Baseline to Week 20 in the Prism treatment group compared to the Sham treatment group. The PCL-5 measures PTSD symptoms. Total scores range from 0-80, with higher scores representing more severe symptoms.
Exploratory outcome: change in ACPL score from Baseline to Week 9 and from Baseline to Week 20
Determine whether PTSD symptoms as measured by the Abbreviated PTSD Checklist for DSM-5 (APCL) decrease from Baseline to Week 9 and from Baseline to Week 20 in the Prism treatment group compared to the Sham treatment group. The ACPL measures PTSD symptoms. Total scores range from 0-16, with higher scores representing more severe symptoms.
Exploratory outcome: change in HAM-D score from Baseline to Week 9 and from Baseline to Week 20
Determine whether depressive symptoms as measured by the Hamilton Depression Inventory (HAM-D) decrease from Baseline to Week 9 and from Baseline to Week 20 in the Prism treatment group compared to the Sham treatment group. The HAM-D measures depression symptoms. Scores range from 0-66, with higher scores representing more severe symptoms.
Exploratory outcome: change in PHQ-9 scores from Baseline to Week 9 and from Baseline to Week 20
Determine whether depressive symptoms as measured by the Patient Health Questionnaire (PHQ-9) decrease from Baseline to Week 9 and from Baseline to Week 20 in the Prism treatment group compared to the Sham treatment group. The PHQ-9 measures depression symptoms. Total scores range from 0-27, with higher scores representing more severe symptoms.
Click on the lead sponsor to view all of their trials.
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
