Accepted for/Published in: JMIR Formative Research
Date Submitted: Dec 9, 2025
Date Accepted: Apr 16, 2026
OTX-202 smartphone app to reduce suicidal ideation among high-risk transition age youths: an open-label, single arm, phase 1 clinical trial
ABSTRACT
Background:
The transition from adolescence to adulthood (18-25 years) is associated with increased risk of suicidal ideation and behaviors. Suicide-focused cognitive behavioral therapies (CBTs) have been shown to significantly reduce suicidal ideation and behaviors but are not widely available to high-risk individuals. Digital therapeutics could improve access to these treatments.
Objective:
This study aimed to evaluate acceptability, safety, and potential for efficacy of OTX-202 among transition age youths (18-25 years) receiving mental healthcare outside an inpatient hospital setting.
Methods:
In this phase 1 single-arm clinical trial, 59 transition age youths with recent suicidal ideation or suicide attempts used OTX-202, a smartphone app designed to deliver suicide-focused CBT, concurrent with usual outpatient mental healthcare. After baseline, eligible patients completed 12 weekly assessments of suicidal ideation, depression, and anxiety.
Results:
From baseline to week 12, participants reported statistically significant and large reductions in suicidal ideation (∆M=-5.1, 95% CI=-3.7 to -6.5, d=0.95). Three (5.1%, 95% CI=0% to 11.2%) participants reported a suicide attempt. Reductions in suicidal ideation and suicide attempt rates were consistent with the results of previously published randomized clinical trials of suicide-focused CBTs. Participants rated OTX-202 in the 97th percentile of usability and completed a mean (SD) of 9.0 (3.5) of 12 app modules, supporting the app’s acceptability. There were no patient deaths, device-related events, or severe adverse events, supporting the app’s safety.
Conclusions:
Results support the safety, acceptability, and potential for efficacy of OTX-202 for reducing suicide risk among transition age youths. Clinical Trial: https://clinicaltrials.gov/study/NCT06008132
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