Status:
NOT_YET_RECRUITING
Feasibility of a Digital Therapeutic for Adults With Posttraumatic Stress Disorder (PTSD)
Lead Sponsor:
Oui Therapeutics, Inc.
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Florida State University
Conditions:
PTSD
Post Traumatic Stress Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is exploring the efficacy of a digital therapeutic app in reducing symptoms of posttraumatic stress disorder (PTSD) in adults.
Detailed Description
The purpose of this study is to conduct a randomized controlled trial to evaluate the usability and feasibility as well as the safety and effectiveness of OTX-601 (version 1) + TAU compared to OTX-601...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 30 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 30 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06868446
Start Date
June 30 2025
End Date
January 30 2026
Last Update
June 19 2025
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