[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623328":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":25,"locations":35,"responsibleParty":52,"collaborators":56,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":66,"eligibilityCriteria":67,"healthyVolunteers":62,"sex":68,"minAge":69,"maxAge":70,"enrollmentInfo":71,"targetDuration":18,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":85,"overallStatus":38,"whyStopped":18,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Charite University, Berlin, Germany","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Digital Intervention (Kiso Mind App) + TAU.","EXPERIMENTAL","The intervention comprises a 12-week digital intervention containing several psychoeducation modules as well as a broad variety of evidence-based psychotherapeutic modules based on CBTp principles. In addition, the digital intervention includes functions to assist with daily challenges, such as medication reminders, mood trackers and emergency contacts.",[13],"Behavioral: Digital: Kiso Mind App",{"label":15,"type":16,"description":17,"interventionNames":18},"Treatment as Usual","NO_INTERVENTION","with Schizophrenia or Schizoaffective Disorder in Germany consists of quarterly psychiatric appointments for psychopharmacological treatment. Psychotherapy is typically limited to one appointment a month, in very rare cases multiple appointments a month.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":18},"BEHAVIORAL","Digital: Kiso Mind App","See above.",[9],[26,31],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},"Pawel Weinstein, M.Sc.","CONTACT","0049 30 450 617 325","pawel.weinstein@charite.de",{"name":32,"role":28,"phone":33,"phoneExt":18,"email":34},"Eric Hahn, PD Dr.","0049 30 450 517 547","eric.hahn@charite.de",[36],{"facility":37,"status":38,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Charité - Universitätsmedizin Berlin","RECRUITING","Berlin","State of Berlin","10117","Germany","DE",{"type":45,"coordinates":46},"Point",[47,48],13.41053,52.52437,{"lat":48,"lon":47},[51],{"name":27,"role":28,"phone":29,"phoneExt":18,"email":30},{"type":53,"investigatorFullName":54,"investigatorTitle":55,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"PRINCIPAL_INVESTIGATOR","Kerem Böge","Prof. Dr. Dr.",[57],{"name":58,"class":59},"Kiso Health GmbH","UNKNOWN","100623328","acceptability-feasibility-and-preliminary-outcomes-of-the-kiso-mind-app-for-outpatients-with-schizophrenia-spectrum-disorders-100623328",false,"NCT07395206","Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Disorders","Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Disorders: A Randomized Controlled Pilot Trial","KISO","Inclusion Criteria:\n\n* ICD-10: F20 Schizophrenia, F25 Schizoaffective Disorder\n* Age: 18 - 65 years\n* Sufficient German Language Proficiency\n* Ability to Use a Smartphone\n\nExclusion Criteria:\n\n* Intensive Psychotherapy Protocols (more than one psychotherapy session a month)\n* CGI-Score \\\u003C 3; \\> 6\n* No smartphone\n* Neurological Disorders or Brain Damage\n* Acute Suicidality\n* Acute Heavy Substance Abuse or Addiction\n* Current Electroconvulsive Therapy","ALL","18 Years","65 Years",{"count":72,"type":73},60,"ESTIMATED","INTERVENTIONAL",[76],"NA","The Kiso pilot study is a randomized controlled trial to test the acceptability and feasibility of a novel digital intervention, namely the Kiso Mind smartphone app. A parallel-group design is utilized. Participants either receive access to the Kiso Mind intervention and treatment-as-usual (TAU) in the experimental condition or receive treatment as usual (TAU) in the control condition. The intervention is designed for participants diagnosed with either schizophrenia (F20.0) or schizoaffective disorder (F25.0) according to the ICD-10.\n\nTo examine acceptability, feasibility, and preliminary effectiveness, both self-report and rater-based assessments are administered at baseline (T0) and at the end of the 12-week intervention period (post-intervention T1). Lastly, a qualitative interview will be conducted with participants from the experimental condition. The primary outcome of the present study is the acceptability and feasibility of the Kiso Mind app. The secondary outcome consists of general psychopathology, and positive-, negative-, depressive symptoms, as well as social functioning and self-efficacy ratings.",[79,80,81,82,83,84],"Psychosis","Psychotic Disorders","Primary Psychotic Disorders","Schizophrenia Spectrum Disorders","Schizophrenia","Schizoaffective Disorder",[79,80,81,83,84,82,86,87],"Digital Intervention","E-Health","2026-02-28",{"date":90,"type":91},"2026-03-03","ACTUAL",{"date":93,"type":91},"2026-01-30",{"date":95,"type":73},"2026-06-30",{"name":5,"class":6},1]