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Social AnxietyVIRTUSNCT06379633

Virtual Reality Exposure for Socially Anxious Adolescents

A study testing In vivo exposure and (Virtual reality) exposure in people with Social Anxiety, run by KU Leuven at 1 site in Belgium.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 to 16 years
Conditions the study is for
Social Anxiety
What is being tested?
In vivo exposure and (Virtual reality) exposure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteBelgium
Study dates
27 Mar 2024to Jun 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 to 16 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Elevated levels of social anxiety (as per the Social Phobia Inventory; ≥ 19)
  • Fluent in Dutch
  • 12-16 years old

Who cannot join

  • 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)
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Elizabeth S. Uduwa-vidanalage, MSc contact

+31 638727709

s.e.uduwavidanalage@uu.nl

Jella De Lee, MSc contact

+3216373075

jella.delee@kuleuven.be

Belgium1 site, 1 recruiting
  • Psychological Institute (PSI) of KU Leuven

    Leuven, 3000 Leuven

    Jella De Lee, MSc, +3216373075, jella.delee@kuleuven.be

    Elizabeth S. Uduwa-vidanalage, MSc, s.e.uduwavidanalage@uu.nl

    Recruiting

Other trials in Belgium

About this study

Official title: Virtual Reality Exposure for Socially Anxious Adolescents: A Randomized Controlled Trial (RCT)

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.

Read more

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
Read the detailed description

This study is going to be a single-blinded, randomized controlled trial (RCT) with three arms: VRE, IVE, and a WL condition. It will follow a mixed-subjects design with condition as a between factor and measurement time-points as a within factor. Due to the study's goal to unravel the effects of VRE, the focus of the intervention will be on exposure in both active conditions (without explicitly including other treatment components like cognitive restructuring). The intervention will take place either at participants' schools or at KU Leuven (i.e., PraxisP - the outpatient treatment facility of the Faculty of Psychology and Educational Sciences, PSI - Psychological Institute) depending on the participants' preference and availability. In case this is not possible, neighboring healthcare practices will be explored as an alternative option. In any case, the training will be held in a separate, private room where the privacy of the participant can be guaranteed. Each active condition will comprise of 7 training sessions in total approximately 90 minutes each.

At pre-assessment, all primary and secondary outcome measures and most of the predictors will be assessed approximately one week prior to the first session. The outcome measures will be re-assessed during the post-assessment (one week after the last session) and the follow up assessments (3-months \& 6-months following the post assessment). During the training sessions, measurements of the mechanisms, remaining predictors, and participant feedback will be acquired and at mid-assessment an additional measurement of the primary outcome measures (e.g., social anxiety measures) will be obtained. Moreover, a brief social anxiety measure will also be conducted on a weekly basis to record symptom-related changes from session to session. Following the training, a qualitative interview will be conducted. This semi-structured interview will be conducted in a convenience sample of participants from both active conditions (e.g., 10-16 participants per condition due to pragmatic considerations and based on general recommendations as to when theoretical data saturation can be reached) to investigate VRE's acceptability and to compare it to IVE. To decrease demand effects, the (online) interview will be conducted by an independent interviewer (e.g., not the therapist) and will be audio-taped so that the interviewer can focus solely on the interaction.

Moreover, in line with good clinical practice and individualized treatment, the specific nature and content of the exposure exercises will be determined for each participant individually by presenting them with an extensive list of the possible exercises (e.g., ordering food in a restaurant, asking a question in class, engaging in a group conversation) in combination with a functional analysis. To ensure that the active conditions are comparable, the IVE condition will be matched to the VRE condition in terms of exposure duration and homework assignments will not be actively encouraged in both conditions. The crucial difference between the two active conditions is that in the IVE condition the exercises take place in real life, whereas in VRE the exercises take place in virtual reality. For the WL condition, the (primary and secondary) outcome measures will be administered before, during, and after the given waiting period (i.e., duration of training sessions) at the same instances as with the active conditions. After that time, participants in the WL condition will have the opportunity to be randomized into IVE and VRE.

Conditions
Social Anxiety
Being tested
In vivo exposure, (Virtual reality) exposure
Keywords
virtual reality exposure, social anxiety, adolescents, inhibitory learning theory, predictors, youth, mental health, mechanisms
Medical subject headings
Psychological Well-Being

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • In vivo exposureBehavioural

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

  • (Virtual reality) exposureBehavioural

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

Study groups in NCT06379633
Study groupRoleWhat they receive
Virtual reality exposure (VRE)ExperimentalParticipants 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.
Receives: Behavioral: (Virtual reality) exposure
In vivo exposure (IVE)Active comparatorSimilarly 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).
Receives: Behavioral: In vivo exposure
WaitlistNo interventionThe 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).

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    General measure of social anxiety

    Measured: 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.

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

    Avoidance measure of social anxiety

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

  3. Behavioral assessment task (BAT) - Peak anxiety

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

    Measured: Pre-assessment, after 8 weeks*

Secondary outcomes (13)
  1. Brief Resilience Scale (BRS)

    General measure of resilience

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

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

    General measure of psychosocial functioning

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

  3. Revised Children's Anxiety and Depression Scale (RCADS)

    General measure of depression and anxiety + Predictor

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

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

    General measure of social self efficacy and mechanism

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

  5. Social Phobia Weekly Summary Scale (SPWSS)

    Weekly measure of social anxiety

    Measured: 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)*

  6. Liebowitz Social Anxiety Scale for Children and Adolescents (LSAS-CA) - Fear subscale

    Secondary measure of fear regarding specific social situations

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

  7. Adolescent Social Cognitions Questionnaire (ASCQ)

    Secondary outcome and mechanism \& predictor

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

  8. Behavioral assessment task (BAT) - Anticipatory anxiety

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

    Measured: Pre-assessment, after 8 weeks*

  9. Behavioral assessment task (BAT) - Physiological assessment

    Mean heart rate measured during the BAT

    Measured: Pre-assessment, after 8 weeks*

  10. Behavioral assessment task (BAT) - Physiological assessment

    Heart-rate variability measured during the BAT

    Measured: Pre-assessment, after 8 weeks*

  11. Behavioral assessment task (BAT) - Physiological assessment

    Skin conductance response measured during the BAT

    Measured: Pre-assessment, after 8 weeks*

  12. Behavioral assessment task (BAT) - Task duration

    Duration of task in seconds

    Measured: Pre-assessment, after 8 weeks*

  13. Behavioral assessment task (BAT) - Confederate rating

    During the BAT, the confederate will rate the participants' social anxiety and performance on a 5-point Likert scale

    Measured: Pre-assessment, after 8 weeks*

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Apr 2024
  2. Study start27 Mar 2024
  3. Primary completionJun 2026 (estimated)
  4. Study completionJun 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned to one of the three conditions and will remain in that condition throughout the training sessions.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06379633
Sponsor's protocol ID
s67010
Acronym
VIRTUS
Status last verified
Apr 2024
First submitted
2 Apr 2024
Last updated
23 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There are no concrete plans to upload individual participant data on to any platforms. However, if other researchers request for the pseudo-anonymized data, then an agreement can be made to share the data.

Publications

  • 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.

    PubMed 40251576

Questions about this trial

What is this clinical trial studying?

A study testing In vivo exposure and (Virtual reality) exposure in people with Social Anxiety, run by KU Leuven at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Elizabeth S. Uduwa-vidanalage, MSc (+31 638727709, s.e.uduwavidanalage@uu.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Brief version of the Social Phobia and Anxiety Inventory (SPAI-18) (time frame: 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.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06379633, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.

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