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An Efficacy Trial of a Digital Therapeutic for Suicide Prevention

Award Number: R42MH123357
ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/23/2020
PERIOD OF PERFORMANCE END DATE: 07/31/2024

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An Efficacy Trial of a Digital Therapeutic for Suicide Prevention - ABSTRACT Suicide is one of the top ten causes of death in the US and suicide rates have increased steadily over the last twenty years. Currently, the most effective treatment options are cognitive behavioral therapies for suicide prevention (CBT-SP), which have been shown to reduce both suicide attempt (SA) risk and suicide ideation (SI). However, access to these treatments is limited because there is a shortage of mental healthcare practitioners, especially suicide specialists. Furthermore, face-to-face therapy, which is the standard treatment modality, is costly and logistically prohibitive. As a consequence, most people who experience suicidal thoughts or behavior do not receive treatment. Oui Therapeutics therefore developed Aviva, a digital therapeutic application accessed via smartphone. It is based on two CBT-SP protocols (the Brief Cognitive Behavioral Therapy and Cognitive Therapy for Suicide Prevention protocol), is accessible, less costly than current treatment options, and consistently implements CBT-SP with high fidelity. Ready accessibility is particularly important for patients recently discharged after hospitalization for SA, as they are 40 times more likely to make another SA within 30 days of discharge than the general population. Oui Therapeutics has completed a Phase I SBIR study, creating a beta version of Aviva targeting the general adult population, and testing the usability and feasibility of this version of Aviva in a single-group, open-label trial. During the 8-week open-label trial, Aviva users showed clinically meaningful improvement on the Scale for Suicidal Ideation and the Patient Health Questionnaire. For the proposed Phase II study, we aim to: 1) add capabilities to enhance the usability of Aviva; 2a) determine the efficacy of Aviva in reducing SA and SI in a randomized controlled trial (RCT), and 2b) determine the mechanisms of action in Aviva in the RCT. SAs and SIs will be tested by enrolling 286 patients in a randomized controlled trial, administered at four clinical sites. Half of the participants will receive treatment as usual plus Aviva, and the other half will receive treatment as usual plus a sham app. We will use time-to-event survival analysis at 12 months to assess SAs and evaluate Aviva’s effects on SI at 6 months using a restricted likelihood repeated measures analysis. Aim 2b will be tested using mediation analyses to examine Aviva’s effects on participants' scores on the Monetary Choice Questionnaire and the Cognitive Emotion Regulation Questionnaire at three and six months. Upon successful completion of the phase II study, we expect Aviva to be ready for distribution in the market. To ensure affordability and accelerate the penetration of the product, Oui will also pursue licensing Aviva to a pharmaceutical company(s) that will work with payers to have Aviva included in their formularies. Ultimately, Oui seeks to curtail the multi-billion dollar economic costs associated with SA and SI and save lives by reducing suicide attempts by 50%.


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: 2025 ( Subtotal = $0 )
2025	2023	OUI THERAPEUTICS INC	4 SCIENCE PARK	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Mental Health Research Grants	000	4	12/6/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $795,120 )
2023	2023	OUI THERAPEUTICS INC	4 SCIENCE PARK	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Mental Health Research Grants	000	4	8/28/2023	NON-COMPETING CONTINUATION	$795,120
														Subtotal = $795,120

Issue Date FY: 2022 ( Subtotal = $954,347 )
2022	2022	OUI THERAPEUTICS, LLC	4 SCIENCE PARK	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Mental Health Research Grants	000	3	7/29/2022	NON-COMPETING CONTINUATION	$949,997
2022	2021	OUI THERAPEUTICS INC	4 SCIENCE PARK	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Mental Health Research Grants	001	2	7/29/2022	COMPETING CONTINUATION	$4,350
														Subtotal = $954,347

Issue Date FY: 2021 ( Subtotal = $1,249,571 )
2021	2021	OUI THERAPEUTICS, LLC	4 SCIENCE PARK	NEW HAVEN	CT	06511	SOUTH CENTRAL CT	USA	Mental Health Research Grants	000	2	7/12/2021	COMPETING CONTINUATION	$1,249,571
														Subtotal = $1,249,571

Grand Total All Awards = $2,999,038

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An Efficacy Trial of a Digital Therapeutic for Suicide Prevention

Award Number: R42MH123357

ORGANIZATION: NATIONAL INSTITUTE OF MENTAL HEALTH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 07/23/2020

PERIOD OF PERFORMANCE END DATE: 07/31/2024

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