Feasibility of a Digital Therapeutic for Adults With Posttraumatic Stress Disorder (PTSD)
July 24, 2026 updated by: Oui Therapeutics, Inc.
Dosage, Feasibility, Acceptability and Usability of OTX-601
This study is exploring the efficacy of a digital therapeutic app in reducing symptoms of posttraumatic stress disorder (PTSD) in adults.
Study Overview
Status
Completed
Conditions
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 (version 2) + TAU in reducing PTSD symptoms from baseline to 7 weeks.
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Tallahassee, Florida, United States, 32306
- Florida State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: OTX-601 Digital Therapeutic - Version 1
A prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD
|
Treatment as usual may include psychotherapy and/or pharmacological interventions.
Prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD
|
|
Experimental: OTX-601 Digital Therapeutic - Version 2
Increased dose of a prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD
|
Treatment as usual may include psychotherapy and/or pharmacological interventions.
Prescription digital therapeutic (increased dose) designed to overcome existing barriers and deliver evidence-based treatment for PTSD
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
PTSD Checklist for DSM-V (PCL-5)
Time Frame: Baseline, week 1, week 2, week 3, and 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.
|
Baseline, week 1, week 2, week 3, and week 7
|
|
System Usability Scale (SUS)
Time Frame: week 1, week 2, and week 3
|
App usability will be ascertained with the System Usability Scale (SUS).
The SUS provides a score from 0 to 100.
An average SUS score equal to or greater than 68 is considered usable.
|
week 1, week 2, and week 3
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety Sensitivity Index 3 (ASI-3)
Time Frame: Baseline, week 1, week 2, week 3 and week 7
|
Change in anxiety sensitivity level will be ascertained with the Anxiety Sensitivity Index 3 (ASI-3).
The ASI-3 total score ranges from 0 to 72 with a higher score indicating greater anxiety sensitivity.
|
Baseline, week 1, week 2, week 3 and week 7
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Patricia Simon, PhD, Oui Therapeutics, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 30, 2025
Primary Completion (Actual)
November 18, 2025
Study Completion (Actual)
November 21, 2025
Study Registration Dates
First Submitted
March 5, 2025
First Submitted That Met QC Criteria
March 5, 2025
First Posted (Actual)
March 11, 2025
Study Record Updates
Last Update Posted (Actual)
July 27, 2026
Last Update Submitted That Met QC Criteria
July 24, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2024-Oui-002-Study1
- R44MH136888 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.