ArticleJMIR formative research2026
OTX-202 Smartphone App to Reduce Suicidal Ideation Among High-Risk Transition-Age Youth: Open-Label, Single-Arm, Phase 1 Clinical Trial.
Article in JMIR formative research, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06008132 ([Trial of device that is not approved or cleared by the U.S. FDA]), which is not on this map. Not yet cited in PubMed.
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[Trial of device that is not approved or cleared by the U.S. FDA]
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4 authors.
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Abstract
backgroundThe transition from adolescence to adulthood (18 to 25 years) is associated with an 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.
objectiveThis study aimed to evaluate the acceptability, safety, and potential efficacy of OTX-202 among transition-age youth (18 to 25 years) receiving mental health care outside an inpatient hospital setting.
methodsIn this phase 1 single-arm clinical trial, 59 transition-age youth with recent suicidal ideation or suicide attempts used OTX-202, a smartphone app designed to deliver suicide-focused CBT, concurrently with usual outpatient mental health care. After baseline, eligible patients completed 12 weekly assessments of suicidal ideation, depression, and anxiety.
resultsFrom baseline to week 12, participants reported statistically significant, large reductions in suicidal ideation (mean difference -5.1, 95% CI -6.5 to -3.7; d=0.95). In total, 3 (5.1%; 95% CI 0%-11.2%) participants reported suicide attempts. Reductions in suicidal ideation and suicide attempt rates were consistent with results from previously published randomized clinical trials of suicide-focused CBTs. Participants rated OTX-202 in the 97th percentile of usability and completed a mean of 9.0 (SD 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.
conclusionsResults support the safety, acceptability, and potential efficacy of OTX-202 for reducing suicide risk among transition-age youth.
trial registrationClinicalTrials.gov NCT06008132; https://clinicaltrials.gov/study/NCT06008132.
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