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

June 16, 2025 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

Not yet recruiting

Conditions

Intervention / Treatment

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 (Estimated)

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 Contact

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: Device Feasibility
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OTX-601 Version 1
A prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD
Device: Digital Therapeutic (Version 1)
Prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD
Behavioral: Treatment as Usual (TAU)
Treatment as usual may include psychotherapy and/or pharmacological interventions.
Experimental: OTX-601 Version 2
Increased dose of a prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD
Device: Digital Therapeutic (Version 2)
Prescription digital therapeutic (increased dose) designed to overcome existing barriers and deliver evidence-based treatment for PTSD
Behavioral: Treatment as Usual (TAU)
Treatment as usual may include psychotherapy and/or pharmacological interventions.

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

Oui Therapeutics, Inc.

Collaborators

National Institute of Mental Health (NIMH)
Florida State University

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 (Estimated)

June 30, 2025

Primary Completion (Estimated)

January 30, 2026

Study Completion (Estimated)

January 30, 2026

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)

June 19, 2025

Last Update Submitted That Met QC Criteria

June 16, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-Oui-002
  • 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

No

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.

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