# Development and Evaluation of a Novel Digital Therapeutic for Adults with Post-Traumatic Stress Disorder

> **NIH NIH R44** · OUI THERAPEUTICS, INC · 2024 · $440,092

## Abstract

ABSTRACT
Post-traumatic stress disorder (PTSD) is a chronic, debilitating health problem that affects 4.7% of adults in the
US and has a total economic cost of $232.2 billion, annually. Effective evidence-based treatments exist but are
underutilized. Substantial barriers to receiving proven cognitive-behavioral treatments include cost, time,
difficulty finding qualified clinicians, and perceived stigma. Thus, it is critical to develop novel therapeutics that
overcome these obstacles and increase widespread accessibility to effective treatment for PTSD. To this end,
this Fast Track project aims to develop OTX-601, a mobile app, digital therapeutic to treat PTSD. During Phase
I, we will develop a usable app, determine the optimal dose, and determine the feasibility, acceptability, and
usability of OTX-601. We will also conduct a pilot randomized controlled trial (RCT) to determine the
preliminary efficacy of OTX-601 in treating PTSD. During Phase II, we will conduct an RCT to determine the
effectiveness of OTX-601 in treating PTSD. Positive results will be the critical initial step for facilitating the
widespread implementation and commercialization of the digital therapeutic to enhance access to highly
personalized PTSD intervention.

## Key facts

- **NIH application ID:** 10924582
- **Project number:** 1R44MH136888-01
- **Recipient organization:** OUI THERAPEUTICS, INC
- **Principal Investigator:** Seth Feuerstein
- **Activity code:** R44 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $440,092
- **Award type:** 1
- **Project period:** 2024-06-05 → 2026-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10924582

## Citation

> US National Institutes of Health, RePORTER application 10924582, Development and Evaluation of a Novel Digital Therapeutic for Adults with Post-Traumatic Stress Disorder (1R44MH136888-01). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10924582. Licensed CC0.

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