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An Efficacy Trial of a Digital Therapeutic for Suicide Prevention

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 2R42MH123357-02
Agency Tracking Number: R42MH123357
Amount: $2,994,688.00
Phase: Phase II
Program: STTR
Solicitation Topic Code: 104
Solicitation Number: PA18-566
Solicitation Year: 2018
Award Year: 2021
Award Start Date (Proposal Award Date): 2021-08-01
Award End Date (Contract End Date): 2024-07-31
Small Business Information
New Haven, CT 06511
United States
DUNS: 081133796
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (203) 725-4024
Business Contact
Phone: (516) 343-2340
Research Institution
COLUMBUS, OH 43210-1016
United States

 Nonprofit College or University

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

* Information listed above is at the time of submission. *

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