Feasibility of a Digital Therapeutic for Adults With Posttraumatic Stress Disorder (PTSD)

Phase 1

Not yet recruiting

• Conditions: PTSD; Post Traumatic Stress Disorder

• Registration Number: NCT06868446
• Lead Sponsor: Oui Therapeutics, Inc.

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 (version 2) + TAU in reducing PTSD symptoms from baseline to 7 weeks.

Study Timeline

• Study First Submitted: 2025-03-05
• Study First Submitted QC: 2025-03-05
• Study First Posted: 2025-03-11
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-16
• Last Update Posted: 2025-06-19
• Study Start: 2025-06-30
• Primary Completion: 2026-01-30
• Study Completion: 2026-01-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
PTSD Checklist for DSM-V (PCL-5)	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.
System Usability Scale (SUS)	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.

Secondary Outcome Measures

Name	Time	Method
Anxiety Sensitivity Index 3 (ASI-3)	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.