protocolSection identificationModule nctId: NCT06379633, orgStudyIdInfo id: s67010, briefTitle: Virtual Reality Exposure for Socially Anxious Adolescents, acronym: VIRTUS, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-27, primaryCompletionDateStruct date: 2026-06, completionDateStruct date: 2026-06, studyFirstPostDateStruct date: 2024-04-23, lastUpdatePostDateStruct date: 2024-04-23, sponsorCollaboratorsModule leadSponsor name: KU Leuven, class: OTHER, collaborators name: Utrecht University, descriptionModule briefSummary: 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.It 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.Moreover, the study has the following (secondary) objectives:* To elucidate potential working mechanisms of VRE and IVE* To identify predictors of adolescents' response to VRE and IVE* To assess to what extent adolescents accept VRE and IVE and how they experience it, conditionsModule conditions: Social Anxiety, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Participants will be randomly assigned to one of the three conditions and will remain in that condition throughout the training sessions., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: All pre-assessments and post-assessment will be conducted by researchers who will be blind to the participants' allocated condition., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: In vivo exposure, interventions name: (Virtual reality) exposure, outcomesModule primaryOutcomes measure: Brief version of the Social Phobia and Anxiety Inventory (SPAI-18), primaryOutcomes measure: Liebowitz Social Anxiety Scale for Children and Adolescents (LSAS-CA) - Avoidance subscale, primaryOutcomes measure: Behavioral assessment task (BAT) - Peak anxiety, secondaryOutcomes measure: Brief Resilience Scale (BRS), secondaryOutcomes measure: Multidimensional Adolescent Functioning Scale (MAFS) - Peer and General functioning subscales, secondaryOutcomes measure: Revised Children's Anxiety and Depression Scale (RCADS), secondaryOutcomes measure: Self-Efficacy Questionnaire for Children (SEQ-C) - Social efficacy subscale, secondaryOutcomes measure: Social Phobia Weekly Summary Scale (SPWSS), secondaryOutcomes measure: Liebowitz Social Anxiety Scale for Children and Adolescents (LSAS-CA) - Fear subscale, secondaryOutcomes measure: Adolescent Social Cognitions Questionnaire (ASCQ), secondaryOutcomes measure: Behavioral assessment task (BAT) - Anticipatory anxiety, secondaryOutcomes measure: Behavioral assessment task (BAT) - Physiological assessment, secondaryOutcomes measure: Behavioral assessment task (BAT) - Physiological assessment, secondaryOutcomes measure: Behavioral assessment task (BAT) - Physiological assessment, secondaryOutcomes measure: Behavioral assessment task (BAT) - Task duration, secondaryOutcomes measure: Behavioral assessment task (BAT) - Confederate rating, otherOutcomes measure: Behavioral inhibition system / behavioral activation system scale (BIS/BAS), otherOutcomes measure: Experiences in Close Relationship Scale - Relationship Structures (ECR-RS), otherOutcomes measure: Immersive Tendency Questionnaire (ITQ) - Factor Involvement, otherOutcomes measure: Unified Theory of Acceptance and Use of Technology (UTAUT-A) - Attitudes subscale, otherOutcomes measure: Unified Theory of Acceptance and Use of Technology (UTAUT-EC) - Expectancy subscale, otherOutcomes measure: VR experience, motivation, need for connection/relatedness, openness to experiences, otherOutcomes measure: Preference for treatment question, otherOutcomes measure: Credibility and Expectancy Questionnaire (CEQ), otherOutcomes measure: Working Alliance Inventory-Short Form (WAI-S), otherOutcomes measure: Exposure log questions - expectancy violation & expectancy change, otherOutcomes measure: Exposure log open-ended questions - expectancy violation & expectancy change, otherOutcomes measure: Exposure log questions - within- & between- session habituation, otherOutcomes measure: Exposure log question- Self-efficacy, otherOutcomes measure: Exposure log question - Presence, otherOutcomes measure: Exposure log questions - Participant feedback, otherOutcomes measure: Acceptability interview, eligibilityModule sex: ALL, minimumAge: 12 Years, maximumAge: 16 Years, stdAges: CHILD, contactsLocationsModule locations facility: Psychological Institute (PSI) of KU Leuven, status: RECRUITING, city: Leuven, zip: 3000 Leuven, country: Belgium, contacts name: Jella De Lee, MSc, role: CONTACT, phone: +3216373075, email: jella.delee@kuleuven.be, contacts name: Elizabeth S. Uduwa-vidanalage, MSc, role: CONTACT, email: s.e.uduwavidanalage@uu.nl, contacts name: Dirk Hermans, PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Iris Engelhard, PhD, role: SUB_INVESTIGATOR, contacts name: Katharina Meyerbröker, PhD, role: SUB_INVESTIGATOR, contacts name: Sara Scheveneels, PhD, role: SUB_INVESTIGATOR, contacts name: Jella De Lee, MSc, role: SUB_INVESTIGATOR, contacts name: Elizabeth S Uduwa-vidanalage, MSc, role: SUB_INVESTIGATOR, geoPoint lat: 50.87959, lon: 4.70093, hasResults: False