OTX-601 Digital Therapeutic: Prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD
OTX-003 Comparator app: Comparator designed to match interface of intervention while providing no active treatment.
Study summary
This study is exploring the efficacy of a digital therapeutic app in reducing symptoms of posttraumatic stress disorder (PTSD) in adults.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Posttraumatic stress disorder (PTSD) diagnosis
* Anxiety Sensitivity Index 3 (ASI-3) scores above 24
* PTSD Checklist for DSM-V (PCL-5) scores above 30
* Understands and speaks English
* Access to a smartphone that is connected to the internet
Exclusion Criteria:
* Score of 24 or lower on the ASI-3
* Score of 30 and below on the PCL-5
* No PTSD diagnosis
* Active psychosis
* Acute intoxication during study baseline
* Enrolled in another treatment research study
* Medical illness that would prevent the completion of interoceptive exposure exercises
Primary outcome measure(s)
Change in PTSD symptoms between baseline and week 7 — Baseline, Week 7 Change in PTSD symptoms will be ascertained with the PTSD Checklist for DSM-V (PCL-5). The PCL-5 total score ranges from 0 to 80, with higher scores indicating more severe symptoms.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.