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Completed

NCT Number: NCT06868446

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

This study is exploring the efficacy of a digital therapeutic app in reducing symptoms of posttraumatic stress disorder (PTSD) in adults.

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Key information

Conditions

PTSD Mental Disorders Post Traumatic Stress Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Florida State University

Tallahassee, Florida, 32306, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OTX-601 Digital Therapeutic - Version 1

Device

Prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD

OTX-601 Digital Therapeutic - Version 2

Device

Prescription digital therapeutic (increased dose) designed to overcome existing barriers and deliver evidence-based treatment for PTSD

Treatment as Usual (TAU)

Behavioral

Treatment as usual may include psychotherapy and/or pharmacological interventions.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Oui Therapeutics, Inc.

Industry

Collaborators

  • Florida State University
  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Dosage, Feasibility, Acceptability and Usability of OTX-601

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 11, 2025
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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