REVEAL Study - Diagnostic Testing for PTSD Using the Senseye Diagnostic Tool

Conditions

• PTSD - Post Traumatic Stress Disorder

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Senseye Diagnostic Tool (DT) — DEVICE
  Software as a Medical Device - the Senseye DT is an investigational diagnostic device that is an application which can be installed on iPhones 13 and newer. The device administers various tasks on the phone screen that the participant completes while video and/or audio is recorded (depending on the task). Recordings are analyzed by a machine learning algorithm to predict the presence and severity of PTSD.
• Clinician Administered PTSD Scale for DSM-5, Revised Version — BEHAVIORAL
  The CAPS-5-R is a standardized stuctured clinical interview for determining PTSD presence and severity. It is a behavioral interview administered by a trained mental health clinician or clinical rater. Participant responses to various questions about traumatic experiences and resulting symptoms are scored to determine PTSD presence according to DSM-5 criteria and PTSD severity according to the CAPS-5-R severity scale.

Study Details

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.

Key Dates

Start date

Feb 23, 2026

Status verified

Apr 2026

Primary completion

Oct 31, 2026

Completion

Oct 31, 2026

Study Design

Enrollment

1,900 participants (estimated)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

DIAGNOSTIC

Arms

• Experimental: PTSD assessment comparing the Senseye DT to the clinical reference standard
  All participants enrolled will be administered both the Senseye DT and the CAPS-5-R. The CAPS-5-R is used as the study's clinical reference standard to establish the "ground truth" for PTSD presence and severity. The order of administration will be randomized.

Primary Outcome Measure

Sensitivity and Specificity of the Senseye DT as an objective PTSD diagnostic test [ Time Frame: Baseline ]

Central Contacts

• Priscilla Nechrebecki
  (833) 459-9365
  [email protected]

Locations (5)

Find similar trials in Aurora, CO

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