[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100514719":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":30,"centralContacts":34,"locations":43,"responsibleParty":62,"collaborators":64,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":26,"enrollmentInfo":90,"targetDuration":26,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":101,"overallStatus":45,"whyStopped":26,"lastUpdateSubmitDate":109,"lastUpdatePostDateStruct":110,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":118},{"fullName":5,"class":6},"Swinburne University of Technology","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Cognitive Behavioural Therapy (CBT)","ACTIVE_COMPARATOR","The standard therapy arm will be based on a focused cognitive behavioural therapy (CBT) protocol for AVHs. Sessions will involve discussing the characteristics of participant's AVHs, before applying core CBT approaches, adapted to the AVH experience, to conduct a thorough cognitive behavioural assessment with a focus on coping strategy enhancement and cognitive restructuring.",[13],"Behavioral: Cognitive behavioural therapy (CBT)",{"label":15,"type":16,"description":17,"interventionNames":18},"Avatar Therapy","EXPERIMENTAL","The experimental arm will use avatar therapy. Sessions will involve generating an audio-visual avatar as a virtual representation of the primary 'voice' that the participant hears. This will be used to recreate AVHs experientially and allow participants to practice alternative ways of responding to the 'voice'. This innovative approach will be combined with the use of broader CBT methods.",[19],"Behavioral: Avatar therapy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"BEHAVIORAL","Avatar therapy","Seven 50-minute therapy sessions conducted by videoconferencing.",[15],null,{"type":22,"name":28,"description":24,"armGroupLabels":29,"otherNames":26},"Cognitive behavioural therapy (CBT)",[9],[31],{"name":32,"affiliation":5,"role":33},"Neil Thomas","PRINCIPAL_INVESTIGATOR",[35,39],{"name":32,"role":36,"phone":37,"phoneExt":26,"email":38},"CONTACT","+61 3 92148742","neilthomas@swin.edu.au",{"name":40,"role":36,"phone":41,"phoneExt":26,"email":42},"Leila Jameel, PhD, D Clin Psy","+61 03 9214 4365","ljameel@swin.edu.au",[44],{"facility":5,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Hawthorn","Victoria","3122","Australia","AU",{"type":52,"coordinates":53},"Point",[54,55],145.0358,-37.81992,{"lat":55,"lon":54},[58],{"name":59,"role":36,"phone":60,"phoneExt":26,"email":61},"Leila Jameel, PhD","61392144365","amethyst@swin.edu.au",{"type":63,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR",[65,67,69,71,73,76,78],{"name":66,"class":6},"University of Copenhagen",{"name":68,"class":6},"University of Manchester",{"name":70,"class":6},"University of Melbourne",{"name":72,"class":6},"Monash University",{"name":74,"class":75},"Perth Voices Clinic","UNKNOWN",{"name":77,"class":75},"University of the Sunshine Coast",{"name":79,"class":6},"University of Toronto","100514719","avatar-mediated-therapy-versus-cognitive-behavioural-therapy-for-persisting-experiences-of-hearing-voices-100514719",false,"NCT05982158","Avatar-mediated Therapy Versus Cognitive Behavioural Therapy for Persisting Experiences of Hearing Voices","Remotely Delivered Avatar-mediated Therapy Versus Cognitive Behavioural Therapy for Persisting Auditory Hallucinations: Randomised Controlled Superiority Trial","AMETHYST","Inclusion Criteria:\n\n* Schizophrenia-related disorder or a mood disorder with psychotic symptoms diagnosis confirmed using the Structured Clinical Interview for DSM (SCID)\n* Experiencing current auditory verbal hallucinations as measured by the Positive and Negative Syndrome Scale (PANSS) item P3 ≥ 4\n* Auditory verbal hallucinations present for at least one year\n* AVHs include significant negative content (PSYRATS item 6 ≥ 2) and\u002For AVHs are distressing (PSYRATS item item 9 ≥ 2)\n* Current treatment with antipsychotic medication, or has been treated with antipsychotic medication in the past, with at least two different antipsychotic compounds, and these have been discontinued due to insufficient treatment response and\u002For poor tolerability.\n* Access to the internet and a computer or other device on which videoconferencing software can be used\n* Sufficient fluency in English for meaningful participation\n* Age 18 or over\n* Ability to give informed consent\n\nExclusion Criteria:\n\n* Auditory verbal hallucinations attributable to a primary substance use disorder or organic disorder\n* Estimated full scale IQ \\\u003C 70 (using the Test of Premorbid Functioning, TOPF)\n* Within the last month or planned at the time of intake: a change of antipsychotic medication,\n* Current or within the past 3 months receipt of individual psychological therapy for hearing voices, or receipt of electro-convulsive therapy or other brain stimulation treatment;\n* AVHs in a language not spoken by the therapists.","ALL","18 Years",{"count":91,"type":92},212,"ESTIMATED","INTERVENTIONAL",[95],"NA","The aim of this study is to compare the effects of a new psychological therapy, Avatar Therapy, to the current standard therapy, Cognitive Behavioural Therapy (CBT), in improving outcomes in people living with psychotic disorders who have persisting experiences of hearing voices (auditory verbal hallucinations, AVHs).",[98,99,100],"Auditory Hallucination","Psychotic Disorders","Schizophrenia and Related Disorders",[102,103,104,105,106,23,107,108],"Auditory verbal hallucinations","Psychosis","Schizophrenia","Psychological therapy","Cognitive behavior therapy","Virtual reality","Telehealth","2024-11-19",{"date":111,"type":112},"2024-11-22","ACTUAL",{"date":114,"type":112},"2023-08-08",{"date":116,"type":92},"2027-06",{"name":5,"class":6},1]