[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100560318":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":39,"centralContacts":43,"locations":49,"responsibleParty":119,"collaborators":123,"id":128,"slug":129,"hasResults":130,"nctId":131,"briefTitle":132,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":130,"sex":135,"minAge":136,"maxAge":12,"enrollmentInfo":137,"targetDuration":12,"studyType":140,"phases":141,"briefSummary":143,"conditions":144,"keywords":149,"overallStatus":52,"whyStopped":12,"lastUpdateSubmitDate":155,"lastUpdatePostDateStruct":156,"startDateStruct":159,"completionDateStruct":161,"leadSponsor":163,"locationsCount":164},{"fullName":5,"class":6},"Medizinische Hochschule Brandenburg Theodor Fontane","OTHER",[8,13,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Exploratory preliminary study","NO_INTERVENTION","General practitioners (n = 10), outpatient psychiatrists and psychologists (n = 10) and their patients (n = 20) will be involved. First, partly structured interviews will be conducted with the general practitioners and the psychiatric\u002Fpsychological professionals as well as the patients they treat in order to record their perspectives on digital health services and the role of digital navigators. In parallel, focus groups will be organized with all three main groups to understand their opinions, concerns and expectations regarding the use of digital health applications and digital navigators. The data collection for the preliminary study extends over a period of 3 months (October - December 2024).",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Training","EXPERIMENTAL","Staff members (n = 6) of participating study cites will be trained to become Digital Navigators. The recruitment and training of the digital navigators will take place over a period of 4 months (October 2024 to January 2025).",[18],"Behavioral: Training for Digital Navigators",{"label":20,"type":15,"description":21,"interventionNames":22},"Treatment team and patient support","The Digital Navigators support the treatment teams in the study centers in the selection and integration of suitable apps and digital health applications (DiGAs). The selected patients (n = 48, 8 per center) are accompanied and supported by the trained navigators for 12 weeks to find a suitable app for them and integrate it into their treatment. A total period of 3 months is planned for both the recruitment of patients and the implementation off the intervention (December 2024 to February 2025).",[23,24],"Behavioral: Support from Digital Navigators to Treatment Team","Behavioral: Support from Digital Navigators to Patients",[26,31,35],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":12},"BEHAVIORAL","Support from Digital Navigators to Treatment Team","The trained professionals (the Digital Navigators) support the treatment teams in the study centers in the selection and integration of suitable apps and digital health applications (DiGAs).",[20],{"type":27,"name":32,"description":33,"armGroupLabels":34,"otherNames":12},"Support from Digital Navigators to Patients","The trained professionals (the Digital Navigators) accompany and support the selected patients to find a suitable app for them and integrate it into their treatment.",[20],{"type":27,"name":36,"description":37,"armGroupLabels":38,"otherNames":12},"Training for Digital Navigators","The training takes place in the six study centers and is preferably aimed at medical assistants.",[14],[40],{"name":41,"affiliation":5,"role":42},"Martin Heinze, Prof","STUDY_CHAIR",[44],{"name":45,"role":46,"phone":47,"phoneExt":12,"email":48},"Julian Schwarz, MD","CONTACT","+49 (0) 33638 83501","Julian.Schwarz@mhb-fontane.de",[50,67,78,89,97,108],{"facility":51,"status":52,"city":53,"state":54,"zip":55,"country":56,"countryCode":57,"cosmosGeoPoint":58,"geoPoint":63,"contacts":64},"Praxis Brandenburg an der Havel","RECRUITING","Brandenburg an der Havel","Brandenburg","14776","Germany","DE",{"type":59,"coordinates":60},"Point",[61,62],12.55,52.41667,{"lat":62,"lon":61},[65],{"name":45,"role":46,"phone":47,"phoneExt":12,"email":66},"julian.schwarz@mhb-fontane.de",{"facility":68,"status":52,"city":69,"state":54,"zip":70,"country":56,"countryCode":57,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Praxis Eberswalde","Eberswalde","16225",{"type":59,"coordinates":72},[73,74],13.81951,52.83492,{"lat":74,"lon":73},[77],{"name":45,"role":46,"phone":47,"phoneExt":12,"email":66},{"facility":79,"status":52,"city":80,"state":54,"zip":81,"country":56,"countryCode":57,"cosmosGeoPoint":82,"geoPoint":86,"contacts":87},"Psychiatrische Institutsambulanz (PIA) Fürstenwalde","Fürstenwalde","15517",{"type":59,"coordinates":83},[84,85],14.06185,52.36067,{"lat":85,"lon":84},[88],{"name":45,"role":46,"phone":47,"phoneExt":12,"email":66},{"facility":90,"status":52,"city":80,"state":54,"zip":91,"country":56,"countryCode":57,"cosmosGeoPoint":92,"geoPoint":94,"contacts":95},"Praxis Fürstenwalde","15518",{"type":59,"coordinates":93},[84,85],{"lat":85,"lon":84},[96],{"name":45,"role":46,"phone":47,"phoneExt":12,"email":66},{"facility":98,"status":52,"city":99,"state":54,"zip":100,"country":56,"countryCode":57,"cosmosGeoPoint":101,"geoPoint":105,"contacts":106},"Psychiatrische Institutsambulanz (PIA) Rüdersdorf","Rüdersdorf","15562",{"type":59,"coordinates":102},[103,104],13.78631,52.46927,{"lat":104,"lon":103},[107],{"name":45,"role":46,"phone":47,"phoneExt":12,"email":66},{"facility":109,"status":52,"city":110,"state":54,"zip":111,"country":56,"countryCode":57,"cosmosGeoPoint":112,"geoPoint":116,"contacts":117},"Psychiatrische Institutsambulanz (PIA) Strausberg","Strausberg","15344",{"type":59,"coordinates":113},[114,115],13.88741,52.57859,{"lat":115,"lon":114},[118],{"name":45,"role":46,"phone":47,"phoneExt":12,"email":66},{"type":120,"investigatorFullName":121,"investigatorTitle":122,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Laura Uchtmann","M.Sc. Laura Uchtmann",[124,126],{"name":125,"class":6},"Harvard Medical School (HMS and HSDM)",{"name":127,"class":6},"Hannover Medical School","100560318","digital-navigators-for-acceptance-and-competence-development-with-mental-health-apps-100560318",false,"NCT06575582","Digital Navigators for Acceptance and Competence Development with Mental Health Apps","DigiNavi","Inclusion Criteria:\n\n* Main diagnosis according to ICD 10 F00-F69, F80-F99\n* Capacity to consent is given\n* Sufficient language skills for an interview in German\n* Participants have access to modern digital hardware (smartphone)\n* Basic knowledge of how to operate a smartphone\n\nExclusion Criteria:\n\n* Acute danger to self or others\n* Patients have received prompt (\\\u003C= 3 weeks) qualified psychiatric or psychotherapeutic treatment\n* Severe organic brain diseases with cognitive deficits\n* Intellectual disability","ALL","18 Years",{"count":138,"type":139},116,"ESTIMATED","INTERVENTIONAL",[142],"NA","The goal of this clinical trial is to learn if and how so called \"Digital Navigators\" (DN) can help general practitioners, outpatient psychiatrists and psychologists as well as their treated patients to use digital mental health apps (DiGAs) and integrate it into their treatment. The main questions it aims to answer are:\n\n* What are the chances and implementation barriers of DN?\n* What are the acceptance and expectations towards DN?\n* Do DN affect the psychological health of patients?\n* Do DN affect the digital health literacy and technical competence of participants?\n\nEmployees of medical teams (e.g. medical assistants) receive training to become a DN. Afterwards patients are accompanied and supported by the DN for 12 weeks to select and use a suitable app for their mental disorder.",[145,146,147,148],"Acceptability of Health Care","Engagement, Patient","Nurse's Role","Mental Disorder",[150,151,152,153,154],"digital health","ehealth","mhealth","mental health","health literacy","2024-08-29",{"date":157,"type":158},"2024-09-03","ACTUAL",{"date":160,"type":158},"2024-07-15",{"date":162,"type":139},"2025-07-14",{"name":5,"class":6},6]