{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T19:17:39Z","timestamp":1790709459543,"version":"4.1.0"},"reference-count":36,"publisher":"JMIR Publications Inc.","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JMIR Form Res"],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>The 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objective<\/jats:title>\n                    <jats:p>This 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>From baseline to week 12, participants reported statistically significant, large reductions in suicidal ideation (mean difference \u20135.1, 95% CI \u20136.5 to \u20133.7; 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\u2019s acceptability. There were no patient deaths, device-related events, or severe adverse events, supporting the app\u2019s safety.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Results support the safety, acceptability, and potential efficacy of OTX-202 for reducing suicide risk among transition-age youth.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial Registration<\/jats:title>\n                    <jats:p>ClinicalTrials.gov NCT06008132; https:\/\/clinicaltrials.gov\/study\/NCT06008132<\/jats:p>\n                  <\/jats:sec>","DOI":"10.2196\/89248","type":"journal-article","created":{"date-parts":[[2026,5,1]],"date-time":"2026-05-01T19:25:07Z","timestamp":1777663507000},"page":"e89248","source":"Crossref","is-referenced-by-count":1,"title":["OTX-202 Smartphone App to Reduce Suicidal Ideation Among High-Risk Transition-Age Youth: Open-Label, Single-Arm, Phase 1 Clinical Trial"],"prefix":"10.2196","volume":"10","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9714-0733","authenticated-orcid":false,"given":"Craig J","family":"Bryan","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-9654-9684","authenticated-orcid":false,"given":"Jarrod","family":"Hay","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0004-3322-4155","authenticated-orcid":false,"given":"Noah","family":"Treangen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-0787-2368","authenticated-orcid":false,"given":"Lauren R","family":"Khazem","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1010","published-online":{"date-parts":[[2026,5,1]]},"reference":[{"key":"ref1","unstructured":"Suicide worldwide in 2021: global health estimatesWorld Health Organization20255232026-04-19https:\/\/www.who.int\/publications\/i\/item\/9789240110069"},{"key":"ref2","unstructured":"Suicide data and statisticsCenters for Disease Control and Prevention202503262026-04-19https:\/\/www.cdc.gov\/suicide\/facts\/data.html"},{"key":"ref3","doi-asserted-by":"publisher","DOI":"10.1037\/bul0000084"},{"key":"ref4","unstructured":"Key substance use and mental health indicators in the United States: results from the 2024 National Survey on Drug Use and Health (HHS Publication No. PEP25-07-007, NSDUH Series H-60)Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services 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