[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582833":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":36,"centralContacts":40,"locations":26,"responsibleParty":46,"collaborators":48,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":26,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":26,"enrollmentInfo":64,"targetDuration":26,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":75,"whyStopped":26,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":26},{"fullName":5,"class":6},"Oui Therapeutics, Inc.","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"OTX-601 Version 1","EXPERIMENTAL","A prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD",[13,14],"Device: Digital Therapeutic (Version 1)","Behavioral: Treatment as Usual (TAU)",{"label":16,"type":10,"description":17,"interventionNames":18},"OTX-601 Version 2","Increased dose of a prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD",[19,14],"Device: Digital Therapeutic (Version 2)",[21,27,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","Digital Therapeutic (Version 1)","Prescription digital therapeutic designed to overcome existing barriers and deliver evidence-based treatment for PTSD",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Digital Therapeutic (Version 2)","Prescription digital therapeutic (increased dose) designed to overcome existing barriers and deliver evidence-based treatment for PTSD",[16],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":26},"BEHAVIORAL","Treatment as Usual (TAU)","Treatment as usual may include psychotherapy and\u002For pharmacological interventions.",[9,16],[37],{"name":38,"affiliation":5,"role":39},"Patricia Simon, PhD","PRINCIPAL_INVESTIGATOR",[41],{"name":42,"role":43,"phone":44,"phoneExt":26,"email":45},"Brian Keenaghan","CONTACT","(203) 200-0482","brian@ouitherapeutics.com",{"type":47,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[49,52],{"name":50,"class":51},"National Institute of Mental Health (NIMH)","NIH",{"name":53,"class":54},"Florida State University","OTHER","100582833","phase-1-feasibility-of-a-digital-therapeutic-for-adults-with-posttraumatic-stress-disorder-ptsd-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":65,"type":66},40,"ESTIMATED","INTERVENTIONAL",[69],"PHASE1","This study is exploring the efficacy of a digital therapeutic app in reducing symptoms of posttraumatic stress disorder (PTSD) in adults.",[72,73],"PTSD","Post Traumatic Stress Disorder",[72],"NOT_YET_RECRUITING","2025-06-16",{"date":78,"type":79},"2025-06-19","ACTUAL",{"date":81,"type":66},"2025-06-30",{"date":83,"type":66},"2026-01-30",{"name":5,"class":6}]