[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100577566":3},{"organization":4,"armGroups":7,"interventions":29,"overallOfficials":47,"centralContacts":52,"locations":62,"responsibleParty":99,"collaborators":101,"id":111,"slug":112,"hasResults":113,"nctId":114,"briefTitle":115,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":119,"sex":120,"minAge":121,"maxAge":122,"enrollmentInfo":123,"targetDuration":34,"studyType":126,"phases":127,"briefSummary":129,"conditions":130,"keywords":134,"overallStatus":64,"whyStopped":34,"lastUpdateSubmitDate":140,"lastUpdatePostDateStruct":141,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},{"fullName":5,"class":6},"Istituto per la Ricerca e l'Innovazione Biomedica","OTHER",[8,14,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group for Anorexia Nervosa","EXPERIMENTAL","Participants diagnosed with Anorexia Nervosa will undergo treatment enhanced with Virtual Reality (VR) and Artificial Intelligence (AI) technologies, specifically the Enhanced Body-Swap system. The intervention targets body perception and emotional regulation to address symptoms and improve treatment outcomes.",[13],"Other: Enhanced Body-Swap for Anorexia Nervosa",{"label":15,"type":10,"description":16,"interventionNames":17},"Intervention Group for Bulimia Nervosa","Participants diagnosed with Bulimia Nervosa will receive treatment incorporating VR and AI technologies, specifically the Emotional Rescripting system. The intervention aims to modify emotional experiences and cognitive responses associated with binge-purge behaviors.",[18],"Other: Emotional Rescripting for Bulimia Nervosa",{"label":20,"type":6,"description":21,"interventionNames":22},"Control Group for Anorexia Nervosa","Participants diagnosed with Anorexia Nervosa will follow the same therapeutic protocol as ARM 1 but without the integration of VR and AI technologies. This group serves as a comparison to assess the added value of VR and AI in treatment.",[23],"Other: Standard Therapy for Anorexia Nervosa (Control)",{"label":25,"type":6,"description":26,"interventionNames":27},"Control Group for Bulimia Nervosa","Participants diagnosed with Bulimia Nervosa will follow the same therapeutic protocol as ARM 2 but without the inclusion of VR and AI technologies. This group serves as a baseline to evaluate the impact of VR and AI in treatment.",[28],"Other: Standard Therapy for Bulimia Nervosa (Control)",[30,35,39,43],{"type":6,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Enhanced Body-Swap for Anorexia Nervosa","The protocol begins with a baseline session, where participants familiarize themselves with their virtual body and provide anamnesis and therapeutic efficacy baseline data. The treatment phase includes 12 bi-weekly sessions where participants embody a virtual avatar in a VR environment. During each session, the Body Mass Index (BMI) of the virtual body is incrementally increased toward a target BMI approximating normal weight (18.5). Follow-ups are conducted at 4, 8, and 12 weeks to assess long-term effects.",[9],null,{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":34},"Emotional Rescripting for Bulimia Nervosa","The protocol starts with an assessment phase (1 session), gathering anamnesis and baseline therapeutic efficacy data. This is followed by an evaluation phase (2 sessions), where participants rate craving responses for virtual foods and environments in immersive VR, with physiological data collected via biosensors. Using this data, a personalized exposure hierarchy is created, combining the most craving-inducing foods and environments into 40 interactive 3D scenarios. The treatment phase involves 9 VR sessions focusing on emotional regulation and craving management. Follow-ups at 4, 8, and 12 weeks evaluate progress.",[15],{"type":6,"name":40,"description":41,"armGroupLabels":42,"otherNames":34},"Standard Therapy for Anorexia Nervosa (Control)","Participants follow a similar structure with a baseline session to collect anamnesis and baseline data, but without VR immersion. The treatment phase consists of 12 bi-weekly sessions of standard cognitive-behavioral therapy (CBT), focusing on addressing maladaptive thought patterns, promoting healthy eating behaviors, and reducing body image disturbances. Follow-ups are conducted at 4, 8, and 12 weeks to monitor progress. No VR or AI technologies are integrated.",[20],{"type":6,"name":44,"description":45,"armGroupLabels":46,"otherNames":34},"Standard Therapy for Bulimia Nervosa (Control)","Participants undergo an assessment phase (1 session) to collect baseline data and an evaluation phase (2 sessions) using standard craving questionnaires without VR immersion or biosensors. The treatment phase includes 9 sessions of traditional CBT targeting binge-purge cycles and emotional triggers. Follow-ups at 4, 8, and 12 weeks monitor progress without the integration of VR or AI technologies.",[25],[48],{"name":49,"affiliation":50,"role":51},"Flavia Marino","Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)","PRINCIPAL_INVESTIGATOR",[53,58],{"name":54,"role":55,"phone":56,"phoneExt":34,"email":57},"Flavia marino","CONTACT","+393395798263","flavia.marino@irib.cnr.it",{"name":59,"role":55,"phone":60,"phoneExt":34,"email":61},"Maria Valeria Maiorana","+393285856656","mariavaleria.maiorana@irib.cnr.it",[63],{"facility":50,"status":64,"city":65,"state":66,"zip":67,"country":66,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"RECRUITING","Messina","Italy","98164","IT",{"type":70,"coordinates":71},"Point",[72,73],15.55256,38.19394,{"lat":73,"lon":72},[76,77,78,81,83,85,87,89,91,93,95,97],{"name":49,"role":55,"phone":34,"phoneExt":56,"email":57},{"name":49,"role":51,"phone":34,"phoneExt":34,"email":34},{"name":79,"role":80,"phone":34,"phoneExt":34,"email":34},"Giovanni Pioggia","SUB_INVESTIGATOR",{"name":82,"role":80,"phone":34,"phoneExt":34,"email":34},"Chiara Failla",{"name":84,"role":80,"phone":34,"phoneExt":34,"email":34},"Franco Galasso",{"name":86,"role":80,"phone":34,"phoneExt":34,"email":34},"Renato Tino",{"name":88,"role":80,"phone":34,"phoneExt":34,"email":34},"Giuseppe Riva",{"name":90,"role":80,"phone":34,"phoneExt":34,"email":34},"Chiara Rossi",{"name":92,"role":80,"phone":34,"phoneExt":34,"email":34},"Fabio Frisone",{"name":94,"role":80,"phone":34,"phoneExt":34,"email":34},"Silvia Pizzoli",{"name":96,"role":80,"phone":34,"phoneExt":34,"email":34},"Giuseppe Farruggio",{"name":98,"role":80,"phone":34,"phoneExt":34,"email":34},"Gaia Roccaforte",{"type":51,"investigatorFullName":49,"investigatorTitle":100,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Head of Unit",[102,105,107,109],{"name":103,"class":104},"Madre Teresa s.r.l","UNKNOWN",{"name":106,"class":104},"Medilink s.r.l.",{"name":108,"class":104},"SB SETEC S.p.A",{"name":110,"class":6},"Catholic University of the Sacred Heart","100577566","ai-and-vr-devices-for-eating-behavior-rehabilitation-100577566",false,"NCT06799962","AI and VR Devices for Eating Behavior Rehabilitation","Assistance and Rehabilitation of Eating Behavior Through Devices Based on Artificial Intelligence and Virtual Reality","ARCADIA-VR","Inclusion Criteria:\n\n* Clinical diagnosis of Anorexia Nervosa or Bulimia Nervosa according to DSM-5-TR (APA, 2013) and ICD-11, confirmed by a public hospital setting\n* Body Mass Index (BMI) between 16 and 32\n* Disorder present for at least 6 months\n* No other concurrent psychotherapeutic interventions during the study\n* All participants with a previous diagnosis will be re-evaluated and confirmed through assessment and consent by expert professionals in the research team (i.e., a neuropsychiatrist and a clinical psychologist)",true,"ALL","15 Years","40 Years",{"count":124,"type":125},80,"ESTIMATED","INTERVENTIONAL",[128],"NA","Eating disorders (ED) affect the relationship with food and body image. Virtual reality (VR), combined with artificial intelligence (AI), offers new clinical solutions, overcoming traditional cognitive behavioral therapy (CBT). The ARCADIA VR project aims to develop devices to treat ED through personalized VR systems (e.g. Enhanced Body-Swap for anorexia, Emotional Rescripting for bulimia) and AI predictive algorithms to monitor severity, risk and efficacy of treatments. These approaches promise better and faster results, improving diagnosis and treatment.",[131,132,133],"Eating Disorders","Anorexia Nervosa","Bulimia Nervosa",[131,132,133,135,136,137,138,139],"Virtual Reality","Artificial Intelligence","Body Perception","Emotional Regulation","Cognitive Behavioral Therapy","2025-04-29",{"date":142,"type":143},"2025-04-30","ACTUAL",{"date":145,"type":143},"2025-01-30",{"date":147,"type":125},"2026-01-31",{"name":5,"class":6},1]