[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584859":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":20,"responsibleParty":35,"collaborators":20,"id":38,"slug":39,"hasResults":40,"nctId":41,"briefTitle":42,"officialTitle":43,"acronym":20,"eligibilityCriteria":44,"healthyVolunteers":40,"sex":45,"minAge":46,"maxAge":47,"enrollmentInfo":48,"targetDuration":20,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":64,"whyStopped":20,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":20},{"fullName":5,"class":6},"Orygen","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL","Third wave VR intervention",[13],"Behavioral: Third wave VR therapy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"BEHAVIORAL","Third wave VR therapy","All participants in this trial will receive the VR intervention which is adapted from third wave CBT protocols (including mindfulness and Acceptance and Commitment Therapy) and focuses on decentering-the ability to step back and view thoughts and emotions as temporary, objective events rather than identifying with them. Decentering has been linked to improved emotional regulation, reduced rumination, and better psychological flexibility, which in turn can lead to improvements in depression and anxiety symptoms. The intervention is clinician-delivered in a clinical setting, one-on-one, over 4-5 sessions (60 min each) across 10-12 weeks. Each session includes psychoeducation, a 15-minute VR experience, and debriefing. Sessions cover three core techniques targeting improvement in decentering ability: 1) arousal reduction via controlled breathing, 2) sitting with discomfort without reacting, and 3) cognitive defusion by changing perception of negative thoughts.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"iMOGEN H Bell, PhD","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Imogen H Bell, PhD","CONTACT","+61430156222","imogen.bell@orygen.org.au",{"name":32,"role":28,"phone":33,"phoneExt":20,"email":34},"Jennifer Nicholas, PhD","+61 399 669 175","jennifer.nicholas@orygen.org.au",{"type":24,"investigatorFullName":36,"investigatorTitle":37,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Imogen Bell","Senior Research Fellow & Psychologist, Principal Investigator, PhD (Clin Psych)","100584859","phase-2-hybrid-type-2-implementation-effectiveness-trial-of-a-third-wave-virtual-reality-treatment-for-youth-depressionanxiety-100584859",false,"NCT06894836","Hybrid Type 2 Implementation-Effectiveness Trial of a Third Wave Virtual Reality Treatment for Youth Depression\u002FAnxiety","Hybrid Type 2 Implementation-Effectiveness Trial of a Third Wave Virtual Reality Treatment for Youth Depression and Anxiety","There are three populations recruited for this trial:\n\nINCLUSION CRITERIA\n\nYoung people\n\n1. Aged between 12-25 years (inclusive)\n2. Current client of a participating youth mental health service\n3. Seeking or receiving treatment for depression and\u002For anxiety\n4. Sufficient command of the English language\n\nClinicians Employed at a participating youth mental health service and involved in the delivery of psychological treatment of young people presenting with depression and anxiety\n\nService staff Work within a participating youth mental health service in a leadership (team lead or service manager) or administrative role.\n\nEXCLUSION CRITERIA:\n\nYoung people\n\n1. Moderate or severe audio or visual condition precluding engagement with the VR equipment (assessed on a case-by-case basis)\n2. Counter indication based on clinical judgement e.g., active suicidal risk or intellectual disability.\n\nClinicians Unable to commit to delivering the MIND intervention (5 sessions over 10-12 weeks).\n\nService staff Nil","ALL","12 Years","25 Years",{"count":49,"type":50},75,"ESTIMATED","INTERVENTIONAL",[53],"PHASE2","This research will evaluate a new virtual reality (VR) intervention to support youth with depression and anxiety. While VR has shown promise for adult mental health, little is known about its use in youth or routine clinical care. The VR intervention is based on Acceptance and Commitment Therapy (ACT) and immerses young people in fun, engaging environments to teach practical coping skills for managing distress. Clinicians within youth mental health services will use the VR intervention within their routine treatment of young people. The study will evaluate both the preliminary effectiveness of the VR intervention for improving youth mental health, as well as real-world implementation outcomes to understand how it can be successfully adopted in clinical settings. The trial will use a single-group, pre-post design, with treating clinicians delivering the intervention to up to 75 young people seeking treatment for depression and anxiety over a 12-week period. Assessments will be conducted at baseline, immediately after the intervention (12 weeks), and four weeks post-intervention (16 weeks).",[56],"Depression Anxiety Disorder",[58,59,60,61,62,63],"Virtual reality","Acceptance and commitment therapy","Youth mental health","Depression","Anxiety","Psychological intervention","NOT_YET_RECRUITING","2025-03-30",{"date":67,"type":68},"2025-04-03","ACTUAL",{"date":70,"type":50},"2025-04-01",{"date":72,"type":50},"2026-10-01",{"name":5,"class":6}]