[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564843":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":40,"locations":50,"responsibleParty":68,"collaborators":34,"id":70,"slug":71,"hasResults":72,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":34,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":91,"overallStatus":53,"whyStopped":34,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"Centre Hospitalier St Anne","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental group","EXPERIMENTAL","the experimental group will use a mobile application for cognitive training for 3 months.",[13],"Device: a mobile application for cognitive training",{"label":15,"type":16,"description":17,"interventionNames":18},"comparative control group","ACTIVE_COMPARATOR","Patients in the control group will use video games with no prominent cognitive involvement",[19],"Device: video games",[21,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DEVICE","a mobile application for cognitive training","Personalized cognitive training (PCT) HappyNeuronwill be delivered via a tablet or mobile application for 24 hours within 12 weeks, with a weekly supervision-call to reinforce their motivation.\n\nHappyNeuron Pro is a digital therapy tool designed for clinicians to provide engaging cognitive therapy via a web-based platform. It is compatible with PC, Mac, iPad, and Android devices and is available in multiple languages. The tool features exercises from established cognitive remediation programs.\n\nFunctionality: The program offers 22 cognitive exercises targeting seven key functions outlined in the MATRICS framework: Processing Speed, Selective Attention, Reasoning and Working Memory, Verbal Memory, Visual Memory, and Auditory Memory. Exercises are customizable to meet individual patient needs, facilitating personalized cognitive training.\n\nUser Experience: Each session comprises brief, self-administered exercises, with the order and difficulty adjusted by clinicians.",[9],[27,28,29],"cognitive training","HappyNeuron Pro","Personalized cognitive training",{"type":22,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"video games","Patients in the control group will use video games with no prominent cognitive involvement no prominent cognitive involvement",[15],null,[36],{"name":37,"affiliation":38,"role":39},"Marie Odile MO KREBS, PROFESSEUR","GHU PARIS Saint-Anne","PRINCIPAL_INVESTIGATOR",[41,46],{"name":42,"role":43,"phone":44,"phoneExt":34,"email":45},"Marie Odile KREBS, PROFESSEUR","CONTACT","+331 456 586 46","MO.KREBS@ghu-paris.fr",{"name":47,"role":43,"phone":48,"phoneExt":34,"email":49},"Linda SCORIELS, PhD","+33140789269","scoriels@ghu-paris.fr",[51],{"facility":52,"status":53,"city":54,"state":34,"zip":34,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Groupe Hospitalier Universitaire Paris - Psychiatrie et Neurosciences, (GHU Paris)","RECRUITING","Paris","France","FR",{"type":58,"coordinates":59},"Point",[60,61],2.3488,48.85341,{"lat":61,"lon":60},[64],{"name":65,"role":43,"phone":66,"phoneExt":34,"email":67},"Khaoussou SYLLA, PhD","0031 45 65 81 66","info-recherche@ghu-paris.fr",{"type":69,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100564843","self-administered-cognitive-personalized-training-in-early-psychosis-100564843",false,"NCT06634446","Self-administered COgnitive Personalized Training in Early Psychosis","Self-administered COgnitive Personalized Training in Early Psychosis: a Randomized Controlled Trial in Adolescents and Young Adults to Assess Efficacy and Efficiency of an EHealth Application Providing Personalized Cognitive Training","SCOPe","Inclusion Criteria:\n\n* Adolescent and young adults, both genders, aged 16 to 35,\n* Seeking help in one of the recruiting centers,\n* Newly diagnosed as experiencing an Episode of Psychosis (reaching criteria as described in the Comprehensive Assessment of at Risk Mental States (CAARMS) within the year\n* Written informed consent signed (and from one legal guardian for minors).\n\nExclusion Criteria:\n\n* Severe and unstabilized medical conditions,\n* Insufficient level in reading and\u002For French language,\n* Absence of medical insurance,\n* Participation in another intervention trial,\n* Enforced hospitalization (ASPDT, ASPPI, ASPRE),\n* Intellectuel Deficiency (IQ\\<70), and \u002F or sensorimotor deficits incompatible with the cognitive training,",true,"ALL","16 Years","35 Years",{"count":83,"type":84},240,"ESTIMATED","INTERVENTIONAL",[87],"NA","The overall objective of SCOPe is to improve early intervention in psychosis by providing an innovative eHealth tool that will enable personalized cognitive training, adapted to the individual's cognitive abilities.\n\nCognitive remediation improves quality of life and functional outcome in patients with chronic psychosis. It would even be more efficacious in the early phase of psychosis by tackling the negative impact of psychosis on education achievement and employment. However, cognitive dysfunctions are often overlooked in FEP and cognitive remediation is not always accessible. New technologies can provide us with youth-friendly, non-stigmatizing tools, such as self administered, training applications so that all first-line clinical settings or professionals, and in fine all patients, can have access, wherever they live, to personalized cognitive training focusing on impaired functions.\n\nEarly psychosis can be associated with inflammation, metabolic deficiency, as well as early structural brain anomalies that reflect brain plasticity abilities and could influence the prognosis and response to cognitive training.\n\nOur background hypothesis is that promoting neuroplasticity by cognitive training could attenuate or reverse early cognitive deficits and improve the overall functional outcome in young patients experiencing FEP and that this effect is modulated by individual brain plasticity abilities.",[90],"First Episode Psychosis (FEP)",[92,93,94,95,96,97,98,99],"First Episode Psychosis (FEP),","schizophrenia","Cognitive Personalized training","adolescents and young adults FEP","personalized cognitive training","Chronic psychosis","Biological Testing","Metabolic Alterations","2024-10-08",{"date":102,"type":103},"2024-10-10","ACTUAL",{"date":105,"type":103},"2021-10-26",{"date":107,"type":84},"2027-12-30",{"name":5,"class":6},1]