REVEAL Study - Diagnostic Testing for PTSD Using the Senseye Diagnostic Tool
NCT: NCT07280065 · RECRUITING
Brief Summary
The goal of the REVEAL PTSD study is to test how well the Senseye DT works as a diagnostic test for Post-traumatic Stress Disorder (PTSD) in adults 18 and older who are experiencing one or more symptoms that might be related to PTSD. The Senseye DT is software as a medical device (SaMD) and is an iPhone app that administers a series of simple tasks on the phone while recording video during the tasks through the front-facing camera. The videos are analyzed by a an Artificial Intelligence (AI) algorithm to identify physiologic signals that might be indicative of PTSD. Data collected in this study will be used to train and tune the AI algorithm, then test it for accuracy. The main questions this study aims to answer are: 1. How accurate is the Senseye DT in detecting PTSD compared to structured clinical interviews, the current clinical standard for diagnostic testing? 2. How accurately does the Senseye DT predict PTSD severity? 3. How fast is the Senseye DT to use compared to structured clinical interviews? Participants will attend a virtual screening visit via video call to determine eligibility and consent to participate. Once enrolled, participants will attend 2 or 3 additional study visits: * Visit 1: A virtual visit where standard mental health assessments will be given by clinical raters trained in mental health and administering these structured clinical interviews. These assessments include the Structured Interview Guide for the Montgomery-Asburg Depression Rating Scale (SIGMA), the Structured Interview Guide for the Hamilton Anxiety Scale (SIGH-A), and the MINI International Neurodiagnostic Interview. The Clinician-Administered PTSD Scale for DSM-5 Revised Version (CAPS-5-R) may also be conducted, if randomly selected. * Visit 2: A visit to use the Senseye DT. For participants near one of the study's physical site locations, this visit will be done in person at the site. For all others, this visit will be conducted virtually. * Visit 3: For participants not randomly selected to have the CAPS-5-R administered at Visit 1, a third and final visit will be scheduled for this assessment. This visit will be conducted virtually. The total expected participation time for enrolled participants is 6-7 hours over the course of 2-3 weeks.
Frequently Asked Questions
What is REVEAL Study - Diagnostic Testing for PTSD Using the Senseye Diagnostic Tool?
REVEAL Study - Diagnostic Testing for PTSD Using the Senseye Diagnostic Tool is a clinical trial registered under NCT07280065. Current status: RECRUITING.
What is the status of NCT07280065?
The current status of NCT07280065 (REVEAL Study - Diagnostic Testing for PTSD Using the Senseye Diagnostic Tool) is: RECRUITING.
When did REVEAL Study - Diagnostic Testing for PTSD Using the Senseye Diagnostic Tool start?
REVEAL Study - Diagnostic Testing for PTSD Using the Senseye Diagnostic Tool started on 2026-02-23.
Official Source
View on ClinicalTrials.gov →Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.