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

Award Number: R44MH136888
ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 06/05/2024
PERIOD OF PERFORMANCE END DATE: 05/31/2026

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


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $0 )
2026	2025	OUI THERAPEUTICS INC	4 SCIENCE PARK	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Mental Health Research Grants	000	2	12/31/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $417,356 )
2025	2025	OUI THERAPEUTICS INC	4 SCIENCE PARK	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Mental Health Research Grants	001	2	7/14/2025	NON-COMPETING CONTINUATION	$0
2025	2025	OUI THERAPEUTICS INC	4 SCIENCE PARK	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Mental Health Research Grants	000	2	6/10/2025	NON-COMPETING CONTINUATION	$417,356
														Subtotal = $417,356

Issue Date FY: 2024 ( Subtotal = $440,092 )
2024	2024	OUI THERAPEUTICS INC	4 SCIENCE PARK	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Mental Health Research Grants	000	1	6/5/2024	NEW	$440,092
														Subtotal = $440,092

Grand Total All Awards = $857,448

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

Award Number: R44MH136888

ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 06/05/2024

PERIOD OF PERFORMANCE END DATE: 05/31/2026

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