[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100599965":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":30,"responsibleParty":56,"collaborators":19,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":65,"eligibilityCriteria":66,"healthyVolunteers":61,"sex":67,"minAge":68,"maxAge":19,"enrollmentInfo":69,"targetDuration":19,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":33,"whyStopped":19,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Fundació Sant Joan de Déu","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"VR-Based Avatar Therapy with Cognitive and Metacognitive Assessments","EXPERIMENTAL","Participants will receive VR-based Avatar Therapy over a 12-week intervention period, consisting of 7 individual therapy sessions. This intervention is designed to externalize and reframe distressing auditory hallucinations using virtual reality.\n\nIn addition to the standard therapy, participants will undergo comprehensive assessments of cognition, metacognition, and social cognition at screening (week 0), baseline (week 12), during the intervention (weeks 12-24), and post-therapy (week 24). These measures will evaluate emotional recognition, attributional style, theory of mind, cognitive flexibility, and trauma history, aiming to explore their role in treatment outcomes.",[13],"Behavioral: VR-Based Avatar Therapy with Cognitive and Metacognitive Assessments",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"BEHAVIORAL","VR-Based Avatar Therapy is a 12-week intervention designed to help patients with psychosis manage distressing auditory hallucinations. The therapy consists of 7 individual sessions using virtual reality (VR) technology to externalize the auditory hallucinations, allowing patients to interact with a computer-generated avatar representing their dominant voice.\n\nIn addition to standard therapy, participants will undergo assessments of cognition, metacognition, and social cognition to explore their impact on treatment outcomes. These assessments include measures of emotion recognition, attributional style, theory of mind, cognitive flexibility, and trauma history. Sessions are conducted using VR headsets and noise-canceling headphones to enhance immersion, and patients receive ongoing therapeutic guidance throughout the process.",[9],null,[21,27],{"name":22,"role":23,"phone":24,"phoneExt":25,"email":26},"Susana Ochoa, PhD","CONTACT","+34936406350","1253","susana.ochoa@sjd.es",{"name":28,"role":23,"phone":24,"phoneExt":19,"email":29},"Luciana Díaz-Cutraro, PhD","luciana.diaz@sjd.es",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Fundació Sant Joan de Déu - Unitat de Recerca del Parc Sanitari Sant Joan de Déu","RECRUITING","Barcelona","Catalonia","08950","Spain","ES",{"type":40,"coordinates":41},"Point",[42,43],2.15899,41.38879,{"lat":43,"lon":42},[46,48,49,51,54],{"name":22,"role":23,"phone":47,"phoneExt":19,"email":26},"+34 93 600 97 51",{"name":28,"role":23,"phone":47,"phoneExt":19,"email":29},{"name":22,"role":50,"phone":19,"phoneExt":19,"email":19},"PRINCIPAL_INVESTIGATOR",{"name":52,"role":53,"phone":19,"phoneExt":19,"email":19},"Luciana Diaz-Cutraro, PhD","SUB_INVESTIGATOR",{"name":55,"role":53,"phone":19,"phoneExt":19,"email":19},"Marina Peniza-Soriano, Master degree",{"type":50,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":19,"oldOrganization":19},"Susana Ochoa","PhD, Research Unit Coordinator","100599965","cognitive-and-metacognitive-evaluation-in-vr-based-avatar-therapy-for-psychosis-100599965",false,"NCT07091344","Cognitive and Metacognitive Evaluation in VR-Based Avatar Therapy for Psychosis","Evaluation of Cognitive, Metacognitive, Social Cognition and Trauma Related-Variables in Patients With Psychosis Receiving VR-Based Avatar Therapy","Meta-VR-AVATAR","\\*\\*Inclusion Criteria:\\*\\*\n\n* Adults aged 18 years or older.\n* Diagnosis of schizophrenia spectrum disorder according to DSM-5 criteria.\n* Experience of persistent auditory hallucinations for at least 3 months (PANSS hallucination score ≥ 3).\n* Stable medication dosage for at least 4 weeks prior to recruitment.\n* Fluent in the spoken language of the study site (Spanish).\n* Able to provide informed consent.\n* Regular psychiatric follow-up care.\n\n\\*\\*Exclusion Criteria:\\*\\*\n\n* Inability to identify a dominant voice for Avatar Therapy intervention.\n* Intellectual disability based on medical history.\n* Active substance abuse.\n* Central nervous system injury or neurological disorders affecting cognitive performance.\n* Severe visual impairment that precludes the use of VR technology.\n* Aversion to virtual reality or prior experience of simulator sickness.\n* Current suicidal ideation or risk.\n* Lack of cooperation or inability to comply with study procedures.","ALL","18 Years",{"count":70,"type":71},30,"ESTIMATED","INTERVENTIONAL",[74],"NA","This study aims to evaluate the relationship between cognitive, metacognitive and social cognition variables in patients with psychosis undergoing VR-based Avatar Therapy for the treatment of auditory hallucinations. In addition to the primary intervention, participants will be assessed using validated tools for emotion recognition, attributional style, theory of mind, neurocognition, and metacognition. The study also explores the potential role of trauma as a predisposing factor. Assessments will be conducted at four time points: screening (week 0), baseline (week 12), intervention period (weeks 12-24), and post-therapy follow-up (week 24). By investigating these variables, this study seeks to better understand their impact on treatment outcomes and contribute to the development of personalized therapeutic approaches.",[77,78],"Schizophrenia Disorders","Treatment Resistant Hallucinations",[80,81,82,83,84,85,86,87,88,89],"VR-based Avatar Therapy","cognition","metacognition","social cognition","psychosis","schizophrenia spectrum disorders","auditory hallucinations","trauma and psychosis","emotion recognition","Personalized therapy","2025-08-22",{"date":92,"type":93},"2025-08-29","ACTUAL",{"date":95,"type":93},"2024-03-01",{"date":97,"type":71},"2026-12-30",{"name":5,"class":6},1]