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

• Status Verified: 2025-03
• Study First Submitted: 2025-03-05
• Study First Submitted QC: 2025-03-05
• Last Update Submitted: 2025-03-05
• Study First Posted: 2025-03-11
• Last Update Posted: 2025-03-11
• Study Start: 2025-03-31
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

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

Inclusion Criteria

The primary inclusion criteria for this study will be a PTSD diagnosis, ASI-3 scores above 24, PCL scores above 30, and understanding and speaking English. The only software/hardware requirements are that participants have access to a smartphone that is connected to the internet.

Exclusion Criteria

1. Score of 24 or lower on the ASI-3, 2) score of 30 and below on the PCL-5, 3) no PTSD diagnosis, 4) active psychosis, 5) Acutely intoxication during study baseline, 6) enrolled in another treatment research study, 8) If applicable, 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.