Diagnostic Testing of Post-Traumatic Stress Disorder (PTSD) Using the Senseye Diagnostic Tool in Adults : United States, Australia, and Decentralized Trial (DCT) Protocol
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.
• The participant is willing and able to read, understand, and sign the approved Informed Consent Form (ICF).
• Age 18 years old or older.
• In the past month, participant presents with at least one of the following:
‣ nightmares or unwanted, intrusive thoughts
⁃ avoidance of specific thoughts or situations
⁃ feelings of being constantly on guard, watchful, or easily startled
⁃ feeling numb or detached from people, activities, or surroundings; and/or
⁃ persistent feelings of guilt or self blame for things that have happened.
⁃ excessive anxiety and worry (apprehensive expectation), occurring more days than not for at least 6 months, about a number of events or activities (such as work or school performance)
⁃ sleep disturbance (difficulty falling or staying asleep, or restless unsatisfying sleep)
⁃ depressed mood: most of the day, nearly every day, feeling sad, empty, or hopeless
⁃ markedly diminished interest or pleasure in activities: loss of interest or pleasure in most activities, nearly every day
⁃ self-report of significant weight loss or gain and/or changes in appetite
⁃ insomnia or hypersomnia: sleeping too little or too much
⁃ psychomotor agitation or retardation: observable restlessness or slowed movements
⁃ abnormal fatigue or loss of energy: feeling tired or lacking energy more than usual
• Deemed likely to comply with the study protocol by the study team, including willing communication of adverse events (AEs), mental health history, current and past psychiatric medication \& treatments, and ability to attend all study visits.
• Participant agrees to provide emergency contact information at Screening Visit and their physical location at each visit (if they are joining the visit remotely).
• Participant is psychologically stable as determined by the investigator or delegate.
• Participant has access to the following:
‣ a device with stable internet and Wi-Fi connection capable of supporting video calls (e.g., tablet, computer with webcam, etc.)
⁃ a second smart device that must be an iPhone 13 or newer (Not inclusive of the iPhone13 Mini)
• Participant home/environment meets criteria for Senseye DT setup (remote visits only)