Virtual Reality Exposure for Socially Anxious Adolescents

ConditionSocial Anxiety

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age12-16

SponsorKU Leuven

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Elevated levels of social anxiety (as per the Social Phobia Inventory; ≥ 19)

Fluent in Dutch

12-16 years old

Severe social anxiety disorder

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

In vivo exposure
Behavioral
Exposure in vivo involves the confrontation with fear-evoking situations in real life.
(Virtual reality) exposure
Behavioral
Exposure in virtual reality involves the confrontation with fear-evoking situations which are generated by a computer using VR technology.

Treatment groups

120 Participants

are divided into 3 treatment groups

Group A: Virtual reality exposure (VRE)Experimental treatment 1 intervention

Group B: In vivo exposure (IVE)Active comparator 1 intervention

Group C: WaitlistNo intervention 0 interventions

Trial outcomes

Primary outcomes

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

General measure of social anxiety

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.

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

Avoidance measure of social anxiety

Time frame

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

Time frame

Pre-assessment, after 8 weeks*

Secondary outcomes

Brief Resilience Scale (BRS)

General measure of resilience

Time frame

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

General measure of psychosocial functioning

Time frame

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)

General measure of depression and anxiety + Predictor

Time frame

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

General measure of social self efficacy and mechanism

Time frame

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

Other outcomes

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

Predictor

Time frame

Pre-assessment

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

Predictor

Time frame

Pre-assessment

Immersive Tendency Questionnaire (ITQ) - Factor Involvement

Predictor

Time frame

Pre-assessment

Unified Theory of Acceptance and Use of Technology (UTAUT-A) - Attitudes subscale

Predictor

Time frame

Pre-assessment

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

KU Leuven

Lead sponsor

Utrecht University

Collaborator

Source ClinicalTrials.gov

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