[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651110":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":38,"locations":45,"responsibleParty":57,"collaborators":43,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":43,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":69,"enrollmentInfo":70,"targetDuration":43,"studyType":73,"phases":74,"briefSummary":76,"conditions":77,"keywords":80,"overallStatus":47,"whyStopped":43,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Samsung Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Digital Therapeutic (AffectUs)","EXPERIMENTAL","Participants use the AffectUs digital therapeutic application, which provides structured social cognition training focused on emotion processing and social cue perception, five times per week for approximately 10-15 minutes per session over a 10-week period (total 50 sessions), in addition to standard psychiatric care.",[13],"Behavioral: Digital therapeutic (AffectUs)",{"label":15,"type":16,"description":17,"interventionNames":18},"Active Control (Psychoeducation)","ACTIVE_COMPARATOR","Participants receive standard psychiatric care in addition to weekly psychoeducational materials covering schizophrenia, medication adherence, stress management, sleep, self-care, and crisis coping strategies over a 10-week period.",[19],"Behavioral: Psychoeducational materials",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Digital therapeutic (AffectUs)","A smartphone-based digital therapeutic application (AffectUs) that provides structured social cognition training focused on emotion processing and social cue perception. Participants use the application five times per week for approximately 10-15 minutes per session over a 10-week period (total 50 sessions). The program is self-guided and delivered through a smartphone application.",[9],[27],"Digital therapeutic application for social cognition training",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Psychoeducational materials","Structured psychoeducational materials providing information about schizophrenia, medication adherence, stress management, and daily self-management. Participants receive one psychoeducational module per week over a 10-week period. The content is informational and does not include social cognition training components.",[15],[33],"Schizophrenia management education",[35],{"name":36,"affiliation":5,"role":37},"Jung-Seok Choi, M.D.","PRINCIPAL_INVESTIGATOR",[39],{"name":40,"role":41,"phone":42,"phoneExt":43,"email":44},"Eunyeong Jang, M.A.","CONTACT","82+10-8685-0502",null,"21yeong.j@gmail.com",[46],{"facility":5,"status":47,"city":48,"state":43,"zip":49,"country":50,"countryCode":43,"cosmosGeoPoint":51,"geoPoint":56,"contacts":43},"RECRUITING","Seoul","06351","South Korea",{"type":52,"coordinates":53},"Point",[54,55],126.9784,37.566,{"lat":55,"lon":54},{"type":37,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Jung-Seok Choi","M.D., Ph.D., Full Professor, Department of Psychiatry, Samsung Medical Center, Sungkyunkwan University School of Medicine","100651110","digital-therapeutics-for-social-cognitive-function-in-schizophrenia-spectrum-disorder-a-randomized-controlled-trial-100651110",false,"NCT07755605","Digital Therapeutics for Social Cognitive Function in Schizophrenia Spectrum Disorder","A Prospective, Randomized Parallel, Single Institution, Researcher-led Clinical Trial on the Effect of Improving Social Cognitive Function by Using Digital Therapy Devices in Patients With Schizophrenia Spectrum Disorder","A. Inclusion Criteria\n\nParticipants must meet all of the following criteria:\n\n1. Adults aged 19 to 60 years.\n2. Meet the diagnostic criteria for schizophrenia or schizoaffective disorder according to DSM-5 and ICD-11.\n3. Have completed at least a middle school education.\n4. Be able to read and write in Korean.\n5. Be able to use a smartphone application independently.\n6. Provide written informed consent before participation.\n7. Receiving stable antipsychotic treatment (dose variation ≤30%) for at least 3 months before enrollment.\n\nExclusion Criteria\n\n1. Current or past diagnosis of intellectual disability.\n2. Initiation of or current participation in structured psychosocial interventions (e.g., cognitive behavioral therapy or social cognition training) within the past 3 months.\n3. Considered by the investigator to be at significant risk of suicide. 4, Pregnant or having a positive pregnancy test at screening.\n\n5\\. Any condition that, in the opinion of the investigator, would make participation unsafe or interfere with study participation or data interpretation.","ALL","19 Years","60 Years",{"count":71,"type":72},60,"ESTIMATED","INTERVENTIONAL",[75],"NA","The purpose of this study is to evaluate the safety and preliminary effectiveness of a smartphone-based digital therapeutic application (AffectUs) for improving social cognition, particularly emotion processing and social cue perception, in individuals with schizophrenia spectrum disorders.\n\nIn this randomized controlled trial, participants will be assigned either to use AffectUs for 10 weeks in addition to treatment as usual or to receive psychoeducational materials and treatment as usual. Participants will complete assessments at baseline, week 5, week 10, and week 15 to evaluate social cognition, clinical outcomes, and safety.",[78,79],"Schizophrenia","Schizoaffecitve Disorder",[81,82,83,84,85,86,87,88,89],"Schizophrenia Spectrum Disorder","Social Cognition","Emotion Recognition","Digital Therapeutics","Psychosocial Rehabilitation","AffectUs","Social Cue Perception","Emotion Processing","Mobile Application","2026-08-19",{"date":92,"type":93},"2026-08-21","ACTUAL",{"date":95,"type":93},"2026-07-15",{"date":97,"type":72},"2027-03",{"name":5,"class":6},1]