[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100545264":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":35,"centralContacts":39,"locations":49,"responsibleParty":77,"collaborators":80,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":85,"sex":91,"minAge":92,"maxAge":93,"enrollmentInfo":94,"targetDuration":24,"studyType":97,"phases":98,"briefSummary":100,"conditions":101,"keywords":103,"overallStatus":52,"whyStopped":24,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"KU Leuven","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Virtual reality exposure (VRE)","EXPERIMENTAL","Participants in the VRE condition will be exposed to various VR-based one-on-one and group social interactions which tend to elicit anxiety. That is, commonly feared situations and events (e.g., raising your hand in class, saying no to a friend, ordering food at a restaurant, calling a classmate to invite them to hang out) will be recreated in the virtual environments. Exercises will be tailored to the participant and provided by clinical psychologists under supervision of experienced CBT therapists (and supervisors). To deliver VRE we will utilize a dynamic and interactive VR-software called 'Social Worlds' developed by CleVR. It has various functions and capabilities (e.g., role-playing, walking around, change of perspective, alteration of dialogue style, number of avatars present in the virtual environment) which enables individualized exposure.",[13],"Behavioral: (Virtual reality) exposure",{"label":15,"type":16,"description":17,"interventionNames":18},"In vivo exposure (IVE)","ACTIVE_COMPARATOR","Similarly to VRE, participants in the IVE condition will be exposed to various one-on-one and group social interactions which tend to elicit anxiety, but they will do so in real-life. The exposure exercises here also will be determined in consultation with the participant. Depending on the given exposure exercise, exposure will either take place at the training location or in its neighborhood (e.g., nearby supermarkets, subway stations, cafes, buses). Exercises will be tailored to the participant and provided by clinical psychologists under supervision of experienced CBT therapists (and supervisors). Importantly, participants will undergo the same amount of exposure sessions as in the VRE condition (to keep exposure time constant).",[19],"Behavioral: In vivo exposure",{"label":21,"type":22,"description":23,"interventionNames":24},"Waitlist","NO_INTERVENTION","The participants in the WL condition will complete the assessments at the same time points as in the active conditions but will not receive any of the sessions until post-assessment has been completed. Then they will be randomly assigned to one of the two active conditions (VRE or IVE).",null,[26,31],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":24},"BEHAVIORAL","In vivo exposure","Exposure in vivo involves the confrontation with fear-evoking situations in real life.",[15],{"type":27,"name":32,"description":33,"armGroupLabels":34,"otherNames":24},"(Virtual reality) exposure","Exposure in virtual reality involves the confrontation with fear-evoking situations which are generated by a computer using VR technology.",[9],[36],{"name":37,"affiliation":5,"role":38},"Dirk Hermans, PhD","PRINCIPAL_INVESTIGATOR",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":24,"email":44},"Elizabeth S. Uduwa-vidanalage, MSc","CONTACT","+31 638727709","s.e.uduwavidanalage@uu.nl",{"name":46,"role":42,"phone":47,"phoneExt":24,"email":48},"Jella De Lee, MSc","+3216373075","jella.delee@kuleuven.be",[50],{"facility":51,"status":52,"city":53,"state":24,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Psychological Institute (PSI) of KU Leuven","RECRUITING","Leuven","3000 Leuven","Belgium","BE",{"type":58,"coordinates":59},"Point",[60,61],4.70093,50.87959,{"lat":61,"lon":60},[64,65,66,67,70,72,74,75],{"name":46,"role":42,"phone":47,"phoneExt":24,"email":48},{"name":41,"role":42,"phone":24,"phoneExt":24,"email":44},{"name":37,"role":38,"phone":24,"phoneExt":24,"email":24},{"name":68,"role":69,"phone":24,"phoneExt":24,"email":24},"Iris Engelhard, PhD","SUB_INVESTIGATOR",{"name":71,"role":69,"phone":24,"phoneExt":24,"email":24},"Katharina Meyerbröker, PhD",{"name":73,"role":69,"phone":24,"phoneExt":24,"email":24},"Sara Scheveneels, PhD",{"name":46,"role":69,"phone":24,"phoneExt":24,"email":24},{"name":76,"role":69,"phone":24,"phoneExt":24,"email":24},"Elizabeth S Uduwa-vidanalage, MSc",{"type":38,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"Dirk Hermans","Full professor, PhD",[81],{"name":82,"class":6},"Utrecht University","100545264","virtual-reality-exposure-for-socially-anxious-adolescents-100545264",false,"NCT06379633","Virtual Reality Exposure for Socially Anxious Adolescents","Virtual Reality Exposure for Socially Anxious Adolescents: A Randomized Controlled Trial (RCT)","VIRTUS","Inclusion:\n\n* Elevated levels of social anxiety (as per the Social Phobia Inventory; ≥ 19)\n* Fluent in Dutch\n* 12-16 years old\n\nExclusion\n\n* Severe social anxiety disorder\n* Severe depression\n* Psychotic symptoms\n* Severe suicidal thoughts and \u002F or severe self-harm\n* Severe substance use\n* Benzodiazepine use and \u002F or a change of psychoactive medication usage (dose, type)\n* Autism spectrum disorder (ASD) diagnosis\n* Current ongoing psychological treatment (or waitlisted) for anxiety disorders and or depression\n* Other urgent psychopathologies and\u002For mismatch between participants' clinical presentation and the offered training\n* Exposure therapy for social anxiety disorder in the past 2 years\n* Another person from the same household is participating in the study\n* Eligible for VR as per the following criteria:\n* History of extreme\u002Fsevere motion sickness (e.g., car sick, sea-sick) and \u002F or experiencing extreme\u002Fsevere symptoms of motion sickness during 3D movies\n* Stereoscopic vision problem or a balance problem that would hinder the VR experience;\n* History of seizures, seizure disorder or epilepsy","ALL","12 Years","16 Years",{"count":95,"type":96},120,"ESTIMATED","INTERVENTIONAL",[99],"NA","Overall in this project, the primary goal is to evaluate the efficacy of virtual reality exposure (VRE) for adolescents with elevated social anxiety using a three-arm randomized controlled trial: (1) virtual reality exposure (VRE); (2) in vivo exposure (IVE); and (3) waitlist (WL) - the control condition.\n\nIt is predicted that both VRE and IVE will be more successful in decreasing social anxiety symptoms than the WL condition at post-assessment and that VRE will be as effective as in vivo in reducing social anxiety symptoms. Furthermore, it is expected that there will be no difference between the two active conditions in the long term (at 3- months \\& 6-months follow up). Similar results are expected in the secondary outcome measures, intended to capture the participants' general well-being.\n\nMoreover, the study has the following (secondary) objectives:\n\n* To elucidate potential working mechanisms of VRE and IVE\n* To identify predictors of adolescents' response to VRE and IVE\n* To assess to what extent adolescents accept VRE and IVE and how they experience it",[102],"Social Anxiety",[104,105,106,107,108,109,110,111],"virtual reality exposure","social anxiety","adolescents","inhibitory learning theory","predictors","youth","mental health","mechanisms","2024-04-17",{"date":114,"type":115},"2024-04-23","ACTUAL",{"date":117,"type":115},"2024-03-27",{"date":119,"type":96},"2026-06",{"name":5,"class":6},1]