Virtual Reality Exposure for Socially Anxious Adolescents

NCT06379633 | Recruiting

• 1 other identifier: s67010
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Social Anxiety

Keywords

virtual reality exposure; social anxiety; adolescents; inhibitory learning theory; predictors; youth; mental health; mechanisms

Outcome Measures

Primary Outcomes (3)

• Brief version of the Social Phobia and Anxiety Inventory (SPAI-18)

  General measure of social anxiety

  Pre-assessment, after 4 weeks, after 8 weeks, follow-up(after 20 weeks), follow up(after 32 weeks)* *Due to practical reasons (e.g., school vacation) the exact number of weeks may change. This applies for all the timepoints except pre-assessment.

• Liebowitz Social Anxiety Scale for Children and Adolescents (LSAS-CA) - Avoidance subscale

  Avoidance measure of social anxiety

  Pre-assessment, after 4 weeks, after 8 weeks, follow-up(after 20 weeks), follow up(after 32 weeks)*

• Behavioral assessment task (BAT) - Peak anxiety

  Subjective units of distress (SUD) measured on a visual analogue scale (VAS); administered immediately after the BAT

  Pre-assessment, after 8 weeks*

Secondary Outcomes (13)

• Brief Resilience Scale (BRS)

  Pre-assessment, after 4 weeks, after 8 weeks, follow-up(after 20 weeks), follow up(after 32 weeks)*

• Multidimensional Adolescent Functioning Scale (MAFS) - Peer and General functioning subscales

  Pre-assessment, after 4 weeks, after 8 weeks, follow-up(after 20 weeks), follow up(after 32 weeks)*

• Revised Children's Anxiety and Depression Scale (RCADS)

  Pre-assessment, after 4 weeks, after 8 weeks, follow-up(after 20 weeks), follow up(after 32 weeks)*

• Self-Efficacy Questionnaire for Children (SEQ-C) - Social efficacy subscale

  Pre-assessment, after 4 weeks, after 8 weeks, follow-up(after 20 weeks), follow up(after 32 weeks)*

• Social Phobia Weekly Summary Scale (SPWSS)

  Pre-assessment, every training week (up to 7 weeks after pre-assessment), after 8 weeks, follow-up(after 20 weeks), follow up(after 32 weeks)*

Other Outcomes (16)

• Behavioral inhibition system / behavioral activation system scale (BIS/BAS)

  Pre-assessment

• Experiences in Close Relationship Scale - Relationship Structures (ECR-RS)

  Pre-assessment

• Immersive Tendency Questionnaire (ITQ) - Factor Involvement

  Pre-assessment

Study Arms (3)

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.

Behavioral: (Virtual reality) exposure

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).

Behavioral: In vivo exposure

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).

Interventions

In vivo exposure BEHAVIORAL

Exposure in vivo involves the confrontation with fear-evoking situations in real life.

In vivo exposure (IVE)

(Virtual reality) exposure BEHAVIORAL

Exposure in virtual reality involves the confrontation with fear-evoking situations which are generated by a computer using VR technology.

Virtual reality exposure (VRE)

Eligibility Criteria

• Age: 12 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Elevated levels of social anxiety (as per the Social Phobia Inventory; ≥ 19)
• Fluent in Dutch
• years old

You may not qualify if:

• Severe social anxiety disorder
• Severe depression
• Psychotic symptoms
• Severe suicidal thoughts and / or severe self-harm
• Severe substance use
• Benzodiazepine use and / or a change of psychoactive medication usage (dose, type)
• Autism spectrum disorder (ASD) diagnosis
• Current ongoing psychological treatment (or waitlisted) for anxiety disorders and or depression
• Other urgent psychopathologies and/or mismatch between participants' clinical presentation and the offered training
• Exposure therapy for social anxiety disorder in the past 2 years
• Another person from the same household is participating in the study
• Eligible for VR as per the following criteria:
• History of extreme/severe motion sickness (e.g., car sick, sea-sick) and / or experiencing extreme/severe symptoms of motion sickness during 3D movies
• Stereoscopic vision problem or a balance problem that would hinder the VR experience;
• History of seizures, seizure disorder or epilepsy

Sponsors & Collaborators

• KU Leuven: lead
• Utrecht University: collaborator

Study Sites (1)

Psychological Institute (PSI) of KU Leuven

Leuven, 3000 Leuven, Belgium

RECRUITING

Related Publications (1)

• Uduwa Vidanalage ES, De Lee J, Hermans D, Engelhard IM, Scheveneels S, Meyerbroker K. VIRTUS: virtual reality exposure training for adolescents with social anxiety - a randomized controlled trial. BMC Psychiatry. 2025 Apr 18;25(1):401. doi: 10.1186/s12888-025-06756-w.

  PMID: 40251576 DERIVED

MeSH Terms

Conditions

Psychological Well-Being

Interventions

Virtual Reality Exposure Therapy

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Dirk Hermans, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth S. Uduwa-vidanalage, MSc

CONTACT

+31 638727709; s.e.uduwavidanalage@uu.nl

Jella De Lee, MSc

CONTACT

+3216373075; jella.delee@kuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: All pre-assessments and post-assessment will be conducted by researchers who will be blind to the participants' allocated condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor, PhD

Model Details: Participants will be randomly assigned to one of the three conditions and will remain in that condition throughout the training sessions.

Study Record Dates

• First Submitted: April 2, 2024
• First Posted: April 23, 2024
• Study Start: March 27, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: April 23, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)