[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100517146":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":73,"collaborators":75,"id":78,"slug":79,"hasResults":80,"nctId":81,"briefTitle":82,"officialTitle":82,"acronym":9,"eligibilityCriteria":83,"healthyVolunteers":80,"sex":84,"minAge":85,"maxAge":24,"enrollmentInfo":86,"targetDuration":24,"studyType":89,"phases":90,"briefSummary":92,"conditions":93,"keywords":95,"overallStatus":53,"whyStopped":24,"lastUpdateSubmitDate":100,"lastUpdatePostDateStruct":101,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":109},{"fullName":5,"class":6},"University Medical Center Groningen","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"VR-VOICES","EXPERIMENTAL","7-10 sessions of 45-60 minutes of individual VR assisted therapy and two booster sessions, in addition to TAU. Participants allocated to VR-VOICES create together with their therapist a VR digital representation (avatar with face, body and voice) of the voice that bothers them most. Patients have dialogues with the avatar, voiced by the therapist. As indicated in the treatment protocol, over the sessions the avatar will become less hostile and the participant will gain more power and resilience over the avatar.",[13],"Behavioral: VR-VOICES",{"label":15,"type":6,"description":16,"interventionNames":17},"Treatment as usual","TAU as described in the current Dutch treatment guidelines, which generally exists of pharmacological treatment, supportive counseling, and psychological interventions such as CBT and coping strategies. This will vary per individual.",[18],"Other: Treatment as usual",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"BEHAVIORAL","7-10 individual VR assisted therapy for voice-hearing session and two booster sessions, in addition to TAU.",[9],null,{"type":6,"name":15,"description":26,"armGroupLabels":27,"otherNames":24},"Treatment as usual as provided by the mental health centers",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Chris Geraets, dr","CONTACT","0031649231353","c.n.w.geraets@umcg.nl",[35,51,63],{"facility":36,"status":37,"city":38,"state":39,"zip":24,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Lentis","NOT_YET_RECRUITING","Groningen","Provincie Groningen","Netherlands","NL",{"type":43,"coordinates":44},"Point",[45,46],6.56667,53.21917,{"lat":46,"lon":45},[49],{"name":50,"role":31,"phone":24,"phoneExt":24,"email":24},"Stynke Castelein, Prof",{"facility":52,"status":53,"city":54,"state":24,"zip":24,"country":40,"countryCode":41,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"GGZ Drenthe","RECRUITING","Assen",{"type":43,"coordinates":56},[57,58],6.5625,52.99667,{"lat":58,"lon":57},[61],{"name":62,"role":31,"phone":24,"phoneExt":24,"email":24},"Gerard van Rijsbergen, dr",{"facility":5,"status":53,"city":38,"state":24,"zip":64,"country":40,"countryCode":41,"cosmosGeoPoint":65,"geoPoint":67,"contacts":68},"9712EW",{"type":43,"coordinates":66},[45,46],{"lat":46,"lon":45},[69,71],{"name":30,"role":31,"phone":70,"phoneExt":24,"email":33},"+31649231353",{"name":30,"role":72,"phone":24,"phoneExt":24,"email":24},"PRINCIPAL_INVESTIGATOR",{"type":74,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[76],{"name":77,"class":6},"ZonMw: The Netherlands Organisation for Health Research and Development","100517146","virtual-reality-therapy-for-voice-hearing-vr-voices-a-randomized-controlled-trial-100517146",false,"NCT06013748","Virtual Reality Therapy for Voice Hearing (VR-VOICES): a Randomized Controlled Trial","Inclusion Criteria:\n\n* Having a DSM-5 diagnosis of a psychiatric disorder\n* Distressing AVH for minimally 3 months.\n* Age 16 years or older\n\nExclusion Criteria:\n\n* Insufficient command of the Dutch language\n* Unable to provide informed consent\n* Primary diagnosis of a substance use disorder, or organic brain disease (such as dementia)\n* A degree of substance abuse that hinders treatment adherence\n* Auditory verbal hallucinations in a language not spoken by therapists\n* Patients cannot receive CBT specifically focused at gaining empowerment over voices during the study period or 6 months prior to enrolment.","ALL","16 Years",{"count":87,"type":88},112,"ESTIMATED","INTERVENTIONAL",[91],"NA","Rationale: Auditory verbal hallucinations (AVH) - hearing voices that others cannot hear - are common in mental illnesses. For many people AVH are distressing, disabling and persistent, despite medication. Current psychological interventions show low to medium effects. Preliminary studies suggest that an innovative empowering psychological therapy using computer simulations representing the AVH (avatars) can be effective for reducing AVH distress and frequency. Virtual reality (VR) has the potential to improve this treatment. Therefore, we developed a novel VR treatment for this problem. In this study, the effect of this treatment will be investigated.\n\nObjective: To test the effect of a novel VR treatment for AVH (VR-VOICES) on distress and frequency of AVH in patients with a psychiatric disorder. Furthermore, to investigate the effect of VR-VOICES on clinical symptoms, quality of life, and healthcare costs of the treatment.",[94],"Hallucinations, Verbal Auditory",[96,97,98,99],"Virtual reality","Auditory hallucination","Voice-hearing","Psychological intervention","2025-09-03",{"date":102,"type":103},"2025-09-10","ACTUAL",{"date":105,"type":103},"2022-10-31",{"date":107,"type":88},"2026-02-01",{"name":5,"class":6},3]