Phase II year
2021
(last award dollars: 2023)
Phase II Amount
$2,994,688
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%.
Public Health Relevance Statement: PROJECT NARRATIVE Through this SBIR grant, Oui Therapeutics will continue developing a digital therapeutic application called Aviva (also referred to OTX-202 in clinical trials) that seeks to reduce suicide attempts. Suicide is a top ten cause of death in the US; nonetheless, there is a limited number of mental healthcare workers and they are often not trained on how to administer suicide prevention protocols. Aviva addresses the above public health challenges by providing a scalable digital solution, which is based on validated suicide prevention protocols that are delivered with high fidelity.
Project Terms: Adult; 21+ years old; Adult Human; adulthood; Appointment; Cause of Death; Clinical Trials; Cognitive Therapy; Cognition Therapy; Cognitive Psychotherapy; cognitive behavior intervention; cognitive behavior modification; cognitive behavior therapy; cognitive behavioral intervention; cognitive behavioral modification; cognitive behavioral therapy; cognitive behavioral treatment; Complement; Complement Proteins; Decision Making; Mental Depression; depression; Exercise; Feasibility Studies; Feedback; Formularies; Future; Goals; Grant; Health; Health Personnel; Health Care Providers; Healthcare Providers; Healthcare worker; health care personnel; health care worker; health provider; health workforce; healthcare personnel; medical personnel; treatment provider; Health Services Accessibility; Access to Care; access to health services; access to services; access to treatment; accessibility to health services; availability of services; care access; health service access; health services availability; service availability; treatment access; Recording of previous events; History; Hospitalization; Hospital Admission; Inpatients; Methods; National Institute of Mental Health; NIMH; Outpatients; Out-patients; Patients; Drug Prescriptions; Drug Prescribing; medication prescription; prescribed medication; Public Health; Questionnaires; Relapse; Relaxation; Risk; Suicide; fatal attempt; fatal suicide; intent to die; suicidality; Suicide attempt; non fatal attempt; nonfatal attempt; suicidal attempt; Survival Analysis; Survival Analyses; Educational process of instructing; Teaching; Testing; Thinking; thoughts; Time; Work; Measures; Price; pricing; Cost Savings; Healthcare; health care; Specialist; base; improved; Suicide prevention; Suicide precaution; prevent suicidality; prevent suicide; suicidality prevention; suicide intervention; Acute; Clinical; Penetration; Phase; Ensure; Psyche structure; mental; Licensing; Logistics; Letters; Randomized Controlled Trials; Therapeutic; Suicidal thoughts; suicidal ideation; suicidal thinking; suicide ideation; thoughts about suicide; Feeling suicidal; Event; System; suicide risk; suicidal risk; experience; skills; Participant; Negotiating; Negotiation; Mediation; economic cost; General Public; General Population; Modality; Cell Phone; Cellular Telephone; iPhone; smart phone; smartphone; Cellular Phone; Provider; Pharmaceutical Agent; Pharmaceuticals; Pharmacological Substance; Pharmacologic Substance; Effectiveness; preventing; prevent; Address; Prevention Protocols; Cognitive; Enrollment; enroll; Small Business Innovation Research Grant; SBIR; Small Business Innovation Research; Update; Development; developmental; Behavioral; open label; open label study; suicidal behavior; suicide behavior; suicide rate; cost; time use; digital; clinical research site; clinical site; efficacy trial; Outcome; Population; suicidal patient; suicide patient; usability; trial comparing; emotion regulation; emotional regulation; psychoeducational; commercial application; standard care; standard treatment; effective therapy; effective treatment; treatment as usual; usual care; reducing suicide; reduce suicidality; reduce suicide; reducing suicidality; phase 1 study; Phase I Study; phase 2 study; phase II study; mobile application; mobile app; mobile device application; recruit; chatbot; chat bot; cost estimate; cost estimation; digital treatment; digital therapeutics; digital therapy; Home
