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

Dosage, Feasibility, Acceptability and Usability of OTX-601

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06868446

Enrollment

Registered

2025-03-11

Start date

2025-06-30

Completion date

2025-11-21

Last updated

2026-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Traumatic Stress Disorder, PTSD

Keywords

PTSD

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.

Interventions

DEVICEOTX-601 Digital Therapeutic - Version 1

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

DEVICEOTX-601 Digital Therapeutic - Version 2

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

BEHAVIORALTreatment as Usual (TAU)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORPatricia Simon, PhD

Oui Therapeutics, Inc.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 28, 2026