In a landmark study published on August 8, 2025, researchers from Yale School of Medicine and The Ohio State University have unveiled compelling evidence that a novel mobile phone application, OTX-202, significantly reduces suicidal behaviors among psychiatric inpatients considered to be at high risk. This breakthrough digital therapeutic intervention, tested in a rigorous multisite randomized controlled trial, demonstrates profound potential for filling a critical treatment gap during the vulnerable post-discharge period when patients traditionally face heightened risk and limited access to specialized care.
The study, appearing in the prestigious journal JAMA Network Open, outlines how OTX-202—a targeted digital therapeutic application designed explicitly to deliver suicide-specific cognitive and behavioral therapy—achieved a staggering 58.3% reduction in the recurrence of suicide attempts following hospital discharge. This finding is particularly noteworthy given that individuals who have previously attempted suicide represent a subset of patients most susceptible to repeated and potentially fatal suicidal actions. Conventional interventions have struggled to maintain long-term efficacy in this population due to accessibility barriers and the complexity of delivering tailored psychotherapy in real-world settings.
Clinically, the intervention’s efficacy extended beyond reducing suicide attempts; patients engaging with OTX-202 also exhibited sustained decreases in suicidal ideation that persisted for up to 24 weeks post-hospitalization. In contrast, participants assigned to an active control app—which provided safety planning and psychoeducational content—initially showed declines in suicidal thoughts that regrettably rebounded to baseline by the 24-week mark. These divergent trajectories underscore the value of specialized, therapeutic content over more general mental health resources in preserving gains during this critical period.
The researchers designed the trial as a multi-site, double-blind randomized controlled study encompassing 339 psychiatric inpatients recruited from six diverse hospitals across the United States. Participants were randomly assigned to receive either the OTX-202 app or an active control application, both adjunctive to treatment as usual. Importantly, the OTX-202 app delivered suicide-specific therapeutic modules grounded in evidence-based cognitive behavioral strategies, whereas the control app focused primarily on safety planning and psychoeducation without direct therapeutic engagement.
One of the key clinical outcome measures utilized was the Clinical Global Impression for Severity of Suicide-Change (CGI-SSC) scale, a clinician-rated instrument widely acknowledged for capturing symptom severity and improvement over time with high reliability across diverse patient populations and settings. Patients using OTX-202 demonstrated significantly greater clinical improvement as per this scale compared to controls, reflecting both symptom mitigation and increased potential for recovery.
The implications of this research are profound in light of the epidemiology of suicide in the United States, where suicide has ascended to become one of the top ten causes of death overall. It ranks second as a cause of mortality among individuals aged 10 to 14 and 25 to 34, third among those 15 to 24, and fourth among adults aged 35 to 44. The alarming upward trend—over a 33% increase in suicide rates since 1999—highlights an escalating public health crisis that demands innovative, scalable interventions capable of reaching patients where traditional services often falter.
Moreover, the economic burden of suicide and suicide attempts is staggering, with estimates indicating that these outcomes cost the U.S. healthcare system and the broader economy approximately half a trillion dollars every year. Despite this, suicide prevention remains uniquely underserved by pharmacologic or widely disseminated prescription products aimed at mitigating risk during high-risk periods post-hospitalization. OTX-202 thus emerges as a promising solution, leveraging mobile technology to provide accessible, cost-effective suicide-specific care at scale.
One of the enduring challenges in suicide prevention has been the scarcity of clinicians trained to provide specialized suicide-specific therapy in outpatient and community settings, particularly during the weeks and months immediately following hospital discharge—a timeframe recognized as the highest risk for completed suicide. Patients frequently face lengthy delays before accessing outpatient care, compounding their vulnerability during this critical interval. OTX-202 attempts to bridge this treatment gap by delivering evidence-based therapeutic content directly via patients’ smartphones, providing continuous support outside traditional clinical environments.
The development of OTX-202 was spearheaded by Oui Therapeutics, a digital therapeutics company dedicated to creating clinically validated mobile interventions for psychiatric populations. Their collaboration with academic investigators at Yale and Ohio State facilitated the rigorous validation of OTX-202’s clinical efficacy through this multisite trial. Such partnerships between industry and academia are crucial for accelerating the translation of digital therapeutics from innovation to real-world impact.
Senior author Dr. Seth Feuerstein, MD, JD, assistant clinical professor of psychiatry at Yale, emphasizes the unparalleled potential of this digital therapeutic: “Patients and those who care for them do not have access to reliable and effective tools and resources to reduce future suicide risk. This population faces arguably the biggest gap in access to effective interventions of any leading killer. The potential clinical and population health impact of this new option is extraordinary.” This sentiment echoes the urgent need for technological solutions that act as adjuncts or alternatives to traditional mental health care.
The study authors caution that while these results are promising, continued research and validation in broader, more diverse populations will be vital to confirm efficacy and inform best practices for integrating digital therapeutics into comprehensive suicide prevention frameworks. Furthermore, while OTX-202 offers scalable mental health support, it is intended to supplement—not replace—high-quality psychiatric care and ongoing clinical monitoring.
The collaborative nature of this study, involving clinicians and researchers from multiple institutions, strengthens the generalizability and rigor of the findings. Yale contributors include Patricia Simon, PhD; Samuel T. Wilkinson, MD; Lauren Astorino, MSN, APRN; Alecia D. Dager, PhD; and Seth Feuerstein, MD, JD, while Ohio State authors include Craig Bryan, PsyD; Kristen M. Carpenter, PhD; Luke Misquitta, MD; Katherine Brownlowe, MD; Lauren R. Khazem, PhD; Jarred Hay; and Austin G. Starkey.
Funding for the study was provided in part by Oui Therapeutics Inc and supported by a grant from the National Institute of Mental Health (R42MH123357). The researchers assert that the content reflects their scientific findings independently and does not represent official NIH positions.
This pioneering research heralds a transformative moment in suicide prevention, demonstrating that digital therapeutic interventions can effectively combat one of the most challenging and devastating public health problems of our time. With technology-enabled solutions like OTX-202, the future of mental health care may become more accessible, personalized, and responsive to the acute needs of vulnerable populations.
Subject of Research: Suicide prevention through digital therapeutic intervention among high-risk psychiatric inpatients.
Article Title: A Digital Therapeutic Intervention for Inpatients With Elevated Suicide Risk.
News Publication Date: August 8, 2025.
Web References:
JAMA Network Open Article
DOI: 10.1001/jamanetworkopen.2025.25809
Oui Therapeutics
References: [Study funded by NIMH Grant R42MH123357; Full article available in JAMA Network Open]
Keywords: Digital therapeutics, suicide prevention, psychiatric inpatients, mobile health, cognitive behavioral therapy, suicide-specific therapy, mental health technology, randomized controlled trial, post-discharge suicide risk, clinical global impression, behavioral health intervention, scalable mental health solutions.
