[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582833":3},{"organization":4,"outcomesModule":7,"designInfo":23,"detailedDescription":31,"studyPopulation":22,"armGroups":32,"interventions":45,"overallOfficials":60,"centralContacts":64,"locations":22,"responsibleParty":70,"collaborators":72,"id":79,"slug":22,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":22,"eligibilityCriteria":84,"healthyVolunteers":80,"sex":85,"minAge":86,"maxAge":22,"enrollmentInfo":87,"targetDuration":22,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":97,"overallStatus":98,"whyStopped":22,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":103,"completionDateStruct":105,"leadSponsor":107,"locationsCount":22},{"fullName":5,"class":6},"Oui Therapeutics, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":22},[9,13],{"measure":10,"description":11,"timeFrame":12},"PTSD Checklist for DSM-V (PCL-5)","Change in PTSD symptoms will be ascertained with the PTSD Checklist for DSM-V (PCL-5). The PCL-5 total score ranges from 0 to 80, with higher scores indicating more severe symptoms.","Baseline, week 1, week 2, week 3, and week 7",{"measure":14,"description":15,"timeFrame":16},"System Usability Scale (SUS)","App usability will be ascertained with the System Usability Scale (SUS). The SUS provides a score from 0 to 100. An average SUS score equal to or greater than 68 is considered usable.","week 1, week 2, and week 3",[18],{"measure":19,"description":20,"timeFrame":21},"Anxiety Sensitivity Index 3 (ASI-3)","Change in anxiety sensitivity level will be ascertained with the Anxiety Sensitivity Index 3 (ASI-3). The ASI-3 total score ranges from 0 to 72 with a higher score indicating greater anxiety sensitivity.","Baseline, week 1, week 2, week 3 and week 7",null,{"allocation":24,"interventionModel":25,"interventionModelDescription":22,"primaryPurpose":26,"observationalModel":22,"timePerspective":22,"maskingInfo":27},"RANDOMIZED","PARALLEL","DEVICE_FEASIBILITY",{"masking":28,"maskingDescription":22,"whoMasked":29},"SINGLE",[30],"PARTICIPANT","The purpose of this study is to conduct a randomized controlled trial to evaluate the usability and feasibility as well as the safety and effectiveness of OTX-601 (version 1) + TAU compared to OTX-601 (version 2) + TAU in reducing PTSD symptoms from baseline to 7 weeks.",[33,40],{"label":34,"type":35,"description":36,"interventionNames":37},"OTX-601 Version 1","EXPERIMENTAL","A prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD",[38,39],"Device: Digital Therapeutic (Version 1)","Behavioral: Treatment as Usual (TAU)",{"label":41,"type":35,"description":42,"interventionNames":43},"OTX-601 Version 2","Increased dose of a prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD",[44,39],"Device: Digital Therapeutic (Version 2)",[46,51,55],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":22},"DEVICE","Digital Therapeutic (Version 1)","Prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD",[34],{"type":47,"name":52,"description":53,"armGroupLabels":54,"otherNames":22},"Digital Therapeutic (Version 2)","Prescription digital therapeutic (increased dose) designed to overcome existing barriers and deliver evidence-based treatment for PTSD",[41],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":22},"BEHAVIORAL","Treatment as Usual (TAU)","Treatment as usual may include psychotherapy and\u002For pharmacological interventions.",[34,41],[61],{"name":62,"affiliation":5,"role":63},"Patricia Simon, PhD","PRINCIPAL_INVESTIGATOR",[65],{"name":66,"role":67,"phone":68,"phoneExt":22,"email":69},"Brian Keenaghan","CONTACT","(203) 200-0482","brian@ouitherapeutics.com",{"type":71,"investigatorFullName":22,"investigatorTitle":22,"investigatorAffiliation":22,"oldNameTitle":22,"oldOrganization":22},"SPONSOR",[73,76],{"name":74,"class":75},"National Institute of Mental Health (NIMH)","NIH",{"name":77,"class":78},"Florida State University","OTHER","100582833",false,"NCT06868446","Feasibility of a Digital Therapeutic for Adults With Posttraumatic Stress Disorder (PTSD)","Dosage, Feasibility, Acceptability and Usability of OTX-601","Inclusion Criteria:\n\n* Posttraumatic stress disorder (PTSD) diagnosis\n* Anxiety Sensitivity Index 3 (ASI-3) scores above 24\n* PTSD Checklist for DSM-V (PCL-5) scores above 30\n* Understands and speaks English\n* Access to a smartphone that is connected to the internet\n\nExclusion Criteria:\n\n* Score of 24 or lower on the ASI-3\n* Score of 30 and below on the PCL-5\n* No PTSD diagnosis\n* Active psychosis\n* Acute intoxication during study baseline\n* Enrolled in another treatment research study\n* Medical illness that would prevent the completion of interoceptive exposure exercises","ALL","18 Years",{"count":88,"type":89},40,"ESTIMATED","INTERVENTIONAL",[92],"PHASE1","This study is exploring the efficacy of a digital therapeutic app in reducing symptoms of posttraumatic stress disorder (PTSD) in adults.",[95,96],"PTSD","Post Traumatic Stress Disorder",[95],"NOT_YET_RECRUITING","2025-06-16",{"date":101,"type":102},"2025-06-19","ACTUAL",{"date":104,"type":89},"2025-06-30",{"date":106,"type":89},"2026-01-30",{"name":5,"class":6}]