AzTrials
AzTrials

PTSD - Post Traumatic Stress DisorderPhase 3NCT07280065

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

A Phase 3 study testing Senseye Diagnostic Tool (DT) and Clinician Administered PTSD Scale for DSM-5, Revised Version in people with PTSD - Post Traumatic Stress Disorder, run by Senseye, Inc. at 6 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
PTSD - Post Traumatic Stress Disorder
What is being tested?
Senseye Diagnostic Tool (DT) and Clinician Administered PTSD Scale for DSM-5, Revised Version
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,900 participants
Where
6 sitesin 2 countries
Study dates
23 Feb 2026to Oct 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
Show all 23Show fewer
  • 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)

Who cannot join

  • 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.
  • Current eye disorders which prevent the patient from using the Senseye DT:
  • Vision impairment preventing ability to read with correction (including corneal disease, dense cataract, diabetic retinopathy, macular degeneration, glaucoma, etc.).
Show all 36Show fewer
  • Use of corrective lenses including glasses and contacts is permitted. Colored contacts and cosmetic lenses that obscure or enhance the pupil are not permitted.
  • Significant eye lid droop blocking the pupil.
  • Persistent blurry vision, headaches, and/or light sensitivity resulting from conditions including abnormal pupil dilation or reactivity (e.g, mydriasis).
  • Recent eye surgeries (within 2 weeks) or planned eye surgeries within the study duration.
  • Intraocular inflammation, including iritis and anterior uveitis.
  • Ocular trauma resulting in uncorrected or permanent bilateral damage.
  • Active suicidal and/or homicidal intent or other self-injurious behavior which may put the participant and/or others at risk per the investigator's clinical judgement, or has suicidal ideation of level 4 or 5 as determined by the C-SSRS.
  • Suicidal behavior within the last year as determined by the C-SSRS at the time of screening.
  • Significant suicidal ideation within the last 6 months as determined by ideation of level 4 or 5 by the C-SSRS at the time of screening.
  • Current reported usage (within 2 weeks of Screening Visit and/or planned ongoing usage during the study) of psychotropic drugs and/or non-psychotropic drugs or medication which may affect use of the Senseye DT:
  • Narcotics/opioids (e.g., Heroin, Vicodin, oxycodone, codeine, Tramadol, etc.).
  • Tricyclic antidepressants (TCAs) (e.g., Tofranil, Pamelor, amitriptyline, doxeprin, etc.).
  • Monoamine Oxidase Inhibitors (MAOIs) (e.g., Emsam, Parnate, Nardil, Marplan, etc.).
  • Select antihypertensive medications (alpha-2 receptor agonists, clonidine, peripheral adrenergic inhibitors, Alpha \& Beta blockers, and Rauwolfia alkaloids). Note: If Prazosin can be abstained from for > 24 hours prior to the Senseye DT visit, the exclusion does not apply for that medication.
  • Stimulants (e.g., Amphetamines, Ritalin, Focalin, pseudoephedrine/Sudafed, ecstasy, cocaine, methamphetamines, cathinones, etc.). Note: Caffeine or nicotine use is not exclusionary. Note: that if Sudafed, pseudoephedrine, and stimulants commonly used to treat ADHD (e.g., Ritalin, Focalin, Adderall, etc. can be abstained from for > 24 hours prior to the Senseye DT visit, the exclusion does not apply for those medications.
  • Psychedelics/psychotomimetics (Lysergic acid, psilocybin, mescaline, phencyclidine, methoxetamine, etc.).
  • Cholinergic or anticholinergic agents (e.g., Urecholine, Pilocar, Aricept, Miostat, Evoxac, ipratropium/Atrovent, oxybutynin/Ditropan, scopolamine, etc.), except antihistamines other than Benadryl or diphenhydramine. Note: If Benadryl/diphenhydramine can be abstained from for > 24 hours prior to the Senseye DT visit, the exclusion does not apply.
  • Spravato or Ketamine.
  • Eye drops unless the participant is able to abstain from use for > 72 hours prior to the Senseye DT visit. Note: Artificial tears can be used if needed during the Senseye DT use.
  • Central Nervous System (CNS) depressants (Benzodiazepines and Barbiturates)
  • Current reported usage (within 2 weeks of Screening Visit and/or planned ongoing usage during the study) of vagal nerve stimulation, deep brain stimulation, transcranial magnetic stimulation, or other stimulation or energy-based therapies.
  • Any condition which precludes the ability for patients to safely and accurately complete clinical assessments, questionnaires, or to follow instructions necessary to administer the Senseye DT (e.g., significant developmental disabilities, language disorders, cognitive deficiencies, or other neurodevelopmental disorders).
  • Medical diagnosis of Traumatic Brain Injury (TBI) within the last 12 months based on participant self-report.
  • Lifetime history of any of the following: surgical procedures involving the brain or meninges, encephalitis, meningitis, degenerative central nervous system (CNS) disorder (e.g., Alzheimer's Disease, Parkinson's Disease), or any other disease/procedure/accident/intervention that, according to the clinician, is deemed associated with significant injury to, or malfunction of, the CNS.
  • Involved in active litigation related to the participant's psychiatric symptoms
  • Pregnancy as determined by self-report.
  • Currently incarcerated.
  • Participant requires a legal authorized representative to consent.
  • Prior enrollment in this study or in other Senseye Machine Learning (ML) studies within the last 12 months.
  • Unwilling or unable to comply with all study related procedures, in the opinion of the investigator, including medical and non-medical procedures.

Trial locations and contacts

6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Priscilla Nechrebecki contact

(833) 459-9365

REVEALPTSD@lindushealth.com

6 sites in 2 countries

United States5 sites, 5 recruiting

  • University of Colorado Anschutz Medical Campus

    Aurora, Colorado, 80045

    Lily Berkowitz, lily.berkowitz@cuanschutz.edu

    Steven Berkowitz, MD

    Recruiting

  • Lindus Health (Virtual Study Site)

    Boston, Massachusetts, 02111

    Trial Manager, (833) 459-9365, REVEALPTSD@lindushealth.com

    Jess Petri, PhD

    Recruiting

  • Lowcountry Center for Veterans Research

    Charleston, South Carolina, 29403

    Stephanie Hart, zeigls@musc.edu

    Ronald Acierno, PhD

    Not yet recruiting

  • Velocity Clinical Research

    Meridian, Idaho, 83642

    Summer Cheek, scheek@velocityclinical.com

    Michael Ratto, mratto@velocityclinical.com

    Recruiting

  • Savannah VA Clinic

    Savannah, Georgia, 31419

    Michelle Pompei, michelle.pompei@va.gov

    Ronald Acierno, PhD

    Not yet recruiting

Other trials in United States

Australia1 site, 1 recruiting

  • Zenko Clinical Pty Ltd (Virtual Study Site)

    Carlton, Victoria, 3053

    Sarah Jacobsen, +61 451 540 502, sarah@zenkoclinical.com.au

    Rene Koopman, PhD

    Recruiting

Other trials in Australia

About this study

Official title: 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.

Read more

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.

Being tested
Senseye Diagnostic Tool (DT), Clinician Administered PTSD Scale for DSM-5, Revised Version
Keywords
PTSD, Trauma, MDD, Depression, GAD, Anxiety, Nightmares, Major Depressive Disorder, Avoidance
Medical subject headings
Combat Disorders, Stress Disorders, Post-Traumatic, Wounds and Injuries, Depression, Anxiety Disorders, Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 VersionBehavioural

    Also called CAPS-5-R

    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 groups in NCT07280065
Study groupRoleWhat they receive
PTSD assessment comparing the Senseye DT to the clinical reference standardExperimentalAll 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.
Receives: Device: Senseye Diagnostic Tool (DT); Behavioral: Clinician Administered PTSD Scale for DSM-5, Revised Version

What is being measured

The primary outcome is the main question the study is designed to answer.

  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%).

    Measured: Baseline

Secondary outcomes (3)

  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.

    Measured: Baseline

  2. 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.

    Measured: Baseline

  3. 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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2025
  2. Study start23 Feb 2026
  3. Primary completionOct 2026 (estimated)
  4. Study completionOct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Crossover
Model description
Participants will be evaluated for PTSD presence and severity using both the CAPS-5-R structured clinical interview \[the clinical reference standard\] and the Senseye Diagnostic Tool (DT) \[the study device\]. The order of these interventions will be randomized - some participants will be assessed with the CAPS-5-R first and Senseye DT second, while others will be assessed with the Senseye DT first and CAPS-5-R second.
Masking
None (open label)
Enrolment
1,900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07280065
Sponsor's protocol ID
CSP-002
Status last verified
Apr 2026
First submitted
21 Nov 2025
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Senseye Diagnostic Tool (DT) and Clinician Administered PTSD Scale for DSM-5, Revised Version in people with PTSD - Post Traumatic Stress Disorder, run by Senseye, Inc. at 6 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Priscilla Nechrebecki ((833) 459-9365, REVEALPTSD@lindushealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sensitivity and Specificity of the Senseye DT as an objective PTSD diagnostic test (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07280065.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in