[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07437872":3,"trial-entities:NCT07437872":102,"trial-summary:NCT07437872":106},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":21,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":38,"secondary_outcomes":55,"sex":62,"minimum_age":63,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":64,"std_ages":77,"locations":80,"central_contacts":98,"overall_officials":99,"references":100,"see_also_links":101},"NCT07437872","2025-077-PAU","Testing Mechanisms of Virtual Reality Exposure Therapy for Social Anxiety","RECRUITING","2028-03-01","2026-03","2026-03-04","2026-02-24","Palo Alto University","OTHER",false,"The purpose of this study is to test mechanisms and processes of virtual reality and augmented reality exposure therapy for social anxiety. There is substantial evidence that virtual reality exposure therapy is an effective treatment for social anxiety. However, it can be difficult to access treatment that needs to be conducted in person. Tests of self-guided (without therapist assistance) virtual reality exposure therapy have had mixed efficacy and tests of augmentation offer an important method to optimize brief interventions. The study objectives are to test a wide range of possible mechanisms and approaches (ranging from single sessions in person to remotely conducted virtual reality exposure therapy) in order to advance the field. The broadness of the proposed research is to provide multiple avenues for inquiry per discussion with IRB chair Dr. Kuo. Depending on the specific line of inquiry some variations will be documented (e.g., multiple consent forms for answering different sub questions of the primary questions listed below).",null,[18,19,20],"no Interaction VRET","Scripted Interactions VRET","Fully Customized Interactions VRET",[],"INTERVENTIONAL","TREATMENT",[25],"NA",{"count":27,"type":28},45,"ESTIMATED",[30],{"type":31,"name":32,"description":33,"armGroupLabels":34},"BEHAVIORAL","ExpandXR","An Mixed Reality Exposure Therapy platform for the Apple Vision Pro",[35,36,37],"no interaction Virtual Reality Exposure Therapy","personalized interaction Virtual Reality Exposure Therapy","structured interaction Virtual Reality Exposure Therapy",[39,43,45,47,49,52,53,54],{"measure":40,"description":41,"timeFrame":42},"Liebowitz Social Anxiety Scale Self Report Version","The Liebowitz Social Anxiety Scale Self Report Version is a 48-item self-report measure of fear and avoidance concerning social interactions and performance situations (e.g., telephoning in public, talking to people in authority). The range of scores is 0-144; higher scores are worse.","Baseline",{"measure":40,"description":41,"timeFrame":44},"21 days",{"measure":40,"description":41,"timeFrame":46},"51 days",{"measure":40,"description":41,"timeFrame":48},"111 days",{"measure":50,"description":51,"timeFrame":42},"Personal Report of Communication Apprehension (PRCA)","The Personal Report of Communication Apprehension is a 24-item that assesses anxiety related to speaking in a variety of situation. The range of scores is 24-120; higher scores are worse.",{"measure":50,"description":51,"timeFrame":44},{"measure":50,"description":51,"timeFrame":46},{"measure":50,"description":51,"timeFrame":48},[56,59,60,61],{"measure":57,"description":58,"timeFrame":42},"Speech Anxiety Thoughts Inventory","The Speech Anxiety Thoughts Inventory is a 23-item self-report measure of assessing the intensity of belief in maladaptive, negative thoughts categorized into two main factors: prediction of poor performance and fear of negative evaluation by the audience. The range of scores is 23-115 with higher scores reflecting greater endorsement of maladaptive thoughts.",{"measure":57,"description":58,"timeFrame":44},{"measure":57,"description":58,"timeFrame":46},{"measure":57,"description":58,"timeFrame":48},"ALL","18 Years",{"inclusion":65,"exclusion":70,"raw_text":76},[66,67,68,69],"Individuals at least 18 years of age","Located in the U.S. with sufficient proximity to Mountain View Campus to attend in person visit(s).","Able to give consent","Social Anxiety Disorder based on Structured Clinical Interview AND\u002FOR self-report score cutoff (LSAS \\> 47).",[71,72,73,74,75],"Current Alcohol or Substance Use Disorder (based on self-report)","Current or prior psychotic related or bipolar disorder (based on self-report)","Unstable psychotropic medication (starting\u002Fstopping medication in past 6 weeks based on selfreport)","Current cognitive behavioral therapy for social anxiety","Impaired vision such that cannot see in VR headset without glasses (contacts okay)","Inclusion Criteria:\n\n* Individuals at least 18 years of age\n* Located in the U.S. with sufficient proximity to Mountain View Campus to attend in person visit(s).\n* Able to give consent\n* Social Anxiety Disorder based on Structured Clinical Interview AND\u002FOR self-report score cutoff (LSAS \\> 47).\n\nExclusion Criteria:\n\n* Current Alcohol or Substance Use Disorder (based on self-report)\n* Current or prior psychotic related or bipolar disorder (based on self-report)\n* Unstable psychotropic medication (starting\u002Fstopping medication in past 6 weeks based on selfreport)\n* Current cognitive behavioral therapy for social anxiety\n* Impaired vision such that cannot see in VR headset without glasses (contacts okay)",[78,79],"ADULT","OLDER_ADULT",[81],{"facility":82,"status":7,"city":83,"state":84,"zip":85,"country":86,"contacts":87,"geoPoint":95},"Palo Alto University Mountain View Campus","Palo Alto","California","94304","United States",[88,93],{"name":89,"role":90,"phone":91,"email":92},"Mikael Rubin, PhD","CONTACT","650-433-3805","mrubin@paloaltou.edu",{"name":89,"role":94},"PRINCIPAL_INVESTIGATOR",{"lat":96,"lon":97},37.44188,-122.14302,[],[],[],[],{"nct_id":4,"conditions":103,"biomarkers":105},[104],"Social Anxiety Disorder",[],{"nct_id":4,"found":107,"summary":108,"prompt_version":118},true,{"design":109,"status":110,"heading":111,"summary":112,"follow_up":113,"word_count":114,"commitments":115,"compensation":116,"drugs_mentioned":117},"This is an interventional study with a planned enrollment of 45 participants. It is testing different approaches to virtual reality exposure therapy for social anxiety.","completed","Virtual Reality Therapy for Social Anxiety Study","This study is testing different ways that virtual reality and augmented reality exposure therapy, using a platform called ExpandXR on the Apple Vision Pro, can help people with social anxiety. Researchers want to understand how these therapies work best, especially when they are self-guided (without a therapist) or done remotely. You might be able to join if you are at least 18 years old, live in the U.S. near Mountain View Campus, can give consent, and have been diagnosed with Social Anxiety Disorder or have a high score on a self-report test (LSAS > 47). The study will measure changes in your social anxiety using the Liebowitz Social Anxiety Scale at the beginning, after 21 days, and again after 51 days. The current status of this study is unclear.","Your social anxiety will be measured at 21 days and 51 days after the start of the study.",129,"You would need to attend in-person visit(s) at the Mountain View Campus. The study will measure your social anxiety at the start, after 21 days, and after 51 days.","Not stated in the trial record.",[32],"v2"]