REVEAL Study - Diagnostic Testing for PTSD Using the Senseye Diagnostic Tool
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorSenseye, Inc.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
The participant is willing and able to read, understand, and sign the approved Informed Consent Form (ICF).
Age 18 years old or older.
nightmares or unwanted, intrusive thoughts
avoidance of specific thoughts or situations
Disqualifiers
Current diagnosis of epilepsy and/or other seizure disorders.
A history of at Screening OR positive at Visit 1 for bipolar I or II, mania, or one or more schizophrenia-spectrum or other psychotic disorders, including schizophrenia, schizoaffective disorder, delusional disorder, psychotic depression, and psychosis.
Compromised facial neuro-ophthalmic integrity (e.g., due to stroke, MS, ALS, or other neurological conditions).
Current diagnosis of dementia, delirium, amnestic disorders, autism, hydrocephalus, posterior cortical atrophy, aphasia, multiple sclerosis, or stroke-related cognitive dysfunction.
Trial design
Design model
Crossover
Treatments tested in this trial
Senseye Diagnostic Tool (DT)
DeviceSoftware 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
BehavioralThe 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.
Treatment groups
1,900 Participants
are divided into 1 treatment groupGroup A: PTSD assessment comparing the Senseye DT to the clinical reference standardExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Sensitivity and Specificity of the Senseye DT as an objective PTSD diagnostic test
Performance goals (lower bound of 95% confidence intervals) are set to ≥0.70 sensitivity and ≥0.70 specificity for the device's binary PTSD diagnostic test result as compared to the Clinical Reference Standard. The Senseye DT would provide a clear, objective diagnostic result that is 70% of the research-quality structured clinical interview accuracy (70% of 100% accuracy). This level of accuracy is clinically sufficient for providing a meaningful diagnostic output for PTSD as it provides an accuracy equivalent to current standard-of-care methods in mental healthcare. In primary care settings where a majority of PTSD patients are initially seen for symptoms, the Senseye DT would provide a 50% improvement in accuracy compared to current methods (70% vs. 20%).
Time frame
BaselineSecondary outcomes
1
Time to administer the Senseye DT compared to the clinical reference standard
Intended to demonstrate a statistically significant difference in time to administer the Senseye DT compared to the CAPS-5-R structured clinical interview. It is expected that the Senseye DT time to administer will be \~73% faster (24 min. vs. 90 min.) compared to the CAPS-5-R. This time difference represents a clinical benefit compared to existing methods, as a research-quality assessment for PTSD with accuracy equivalent to current real-world standard of care can be delivered in less time.
Time frame
Baseline2
Agreement between the Senseye DT PTSD severity score output and the CAPS-5-R severity scale
Intended to validate the Senseye DT's capability to output a PTSD severity rating. A valid output will be a Senseye DT severity output that is shown to be correlated with the CAPS-5-R severity rating via a regression analysis.
Time frame
Baseline3
To demonstrate the Senseye DT's clinical utility in identifying individuals recommended for treatment intervention for PTSD, as assessed by an independent clinician panel.
Endpoint is intended to demonstrate the Senseye DT's clinical utility in identifying individuals who require treatment intervention for PTSD, as assessed by an independent clinician panel. This endpoint evaluates whether the device output aligns with clinical decision-making beyond diagnostic classification alone, as treatment necessity does not always correspond directly to diagnostic status. The lower bound of the 95% confidence intervals for both sensitivity and specificity must be ≥0.70 to establish the device can reliably support clinical treatment decisions. Overall diagnostic concordance will be summarized using Cohen's kappa coefficient to quantify agreement between device classification and clinician panel assessment.
Time frame
BaselineOther outcomes
1
Number of Serious Adverse Device Effects (SADEs).
Evaluate the number of SADEs occurring during the trial related or possibly related to the Senseye DT.
Time frame
Baseline to study completion, an average of 2 weeks.2
Device positive predictive value (PPV) and negative predictive value (NPV).
Evaluate the PPV and NPV for the Senseye DT.
Time frame
Baseline3
Participant satisfaction for using the Senseye DT compared to the CAPS-5-R structured clinical interview.
Evaluate participant preference information and satisfaction for using the Senseye DT compared to the CAPS-5-R. Data will be collected on participant-completed surveys.
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov