A mobile phone application designed to deliver suicide-specific therapy has demonstrated significant efficacy in reducing suicidal behavior among high-risk psychiatric patients, according to a multi-site randomized controlled trial published in JAMA Network Open. The study, conducted by researchers at Yale School of Medicine and The Ohio State University Wexner Medical Center, found that OTX-202 reduced the recurrence of post-discharge suicide attempts by 58.3% among patients who had previously attempted suicide.
Clinical Trial Results
The double-blind randomized controlled trial involved 339 psychiatric inpatients from six diverse hospitals across the United States. Participants were randomly assigned to either the OTX-202 app or an active control app, both in addition to their usual treatment. The OTX-202 app delivered a suicide-specific therapy module while the control app included safety planning and psychoeducation.
Users of OTX-202 experienced sustained reductions in suicidal thoughts for up to 24 weeks after psychiatric hospitalization. In contrast, patients who used the active control app showed early improvement, but suicidal thoughts rebounded by week 24. Compared to the active control, patients using OTX-202 were significantly more likely to show clinical improvement, as measured by the Clinical Global Impression for Severity of Suicide-Change (CGI-SSC) scale.
Addressing Critical Treatment Gaps
"Although suicide-specific therapy is highly effective for reducing suicidal thoughts and urges, finding therapists who know how to do this life-saving therapy after leaving the hospital can be challenging. OTX-202 provides a possible solution to that problem," said study co-first author Craig Bryan, PsyD, professor in Ohio State's Department of Psychiatry and Behavioral Health and director of its Suicide Prevention Program.
The intervention addresses a significant healthcare challenge, as suicide remains among the top 10 causes of death in the U.S. It is the second leading cause of death among individuals aged 10–14 and 25–34, the third leading cause among those aged 15–24, and the fourth leading cause among those aged 35–44. Since 1999, suicide rates have risen by more than 33%.
Healthcare System Impact
Each year, more than 1 million adults engage in nonfatal suicidal behavior, and nearly 500,000 are hospitalized for suicide attempts. Suicide and suicide attempts cost the U.S. healthcare system and broader economy an estimated $500 billion annually, underscoring the urgent need for scalable, effective, and economically viable interventions. Notably, suicide is the only top killer without any prescription products for the vast majority of patients at risk.
"The weeks and months following a suicide crisis and discharge from a hospital are among the highest risk periods for suicide attempts and mortality, making it imperative to offer effective, suicide-specific interventions during this vulnerable window. OTX-202 addresses this critical need," said co-first author Patricia Simon, PhD, Assistant Professor Adjunct at Yale School of Medicine.
Technology Solution
OTX-202, developed by Oui Therapeutics, offers a scalable and cost-effective approach during the critical gap between hospital discharge and outpatient care access. "It can take weeks to months to see an outpatient provider after discharge; however, the weeks and months after discharge from psychiatric hospitalization are among the highest risk periods for suicide mortality," Simon noted.
Senior author Seth Feuerstein, MD, JD, assistant clinical professor of psychiatry at Yale, emphasized the broader implications: "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."
The research was supported in part by Oui Therapeutics Inc and by a grant from the National Institute of Mental Health (R42MH123357). The study represents a collaborative effort between Yale authors Patricia Simon, PhD; Samuel T. Wilkinson, MD; Lauren Astorino, MSN, APRN; Alecia D. Dager, PhD; and Seth Feuerstein, MD, JD, along with Ohio State authors Craig Bryan, PsyD; Kristen M. Carpenter, PhD; Luke Misquitta, MD; Katherine Brownlowe, MD; Lauren R. Khazem, PhD; Jarred Hay and Austin G. Starkey.
