Virtual Reality Exposure for Socially Anxious Adolescents

Social Anxiety Clinical Trial

— VIRTUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06379633
• Other study ID #: s67010
• Status: Recruiting
• Phase: N/A
• Start date: March 27, 2024
• Est. completion date: June 2026

Study information

• Verified date: April 2024
• Source: KU Leuven
• Contact: Elizabeth S. Uduwa-vidanalage, MSc
• Phone: +31 638727709
• Email: s.e.uduwavidanalage[@]uu.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 16 Years

Eligibility

Inclusion:

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

• Fluent in Dutch

• 12-16 years old

Exclusion

• 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

Related Conditions & MeSH terms

• Social Anxiety

Intervention

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

Locations

Country	Name	City	State
Belgium	Psychological Institute (PSI) of KU Leuven	Leuven

Sponsors (2)

Lead Sponsor	Collaborator
KU Leuven	Utrecht University

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Behavioral inhibition system / behavioral activation system scale (BIS/BAS)	Predictor	Pre-assessment
Other	Experiences in Close Relationship Scale - Relationship Structures (ECR-RS)	Predictor	Pre-assessment
Other	Immersive Tendency Questionnaire (ITQ) - Factor Involvement	Predictor	Pre-assessment
Other	Unified Theory of Acceptance and Use of Technology (UTAUT-A) - Attitudes subscale	Predictor	Pre-assessment
Other	Unified Theory of Acceptance and Use of Technology (UTAUT-EC) - Expectancy subscale	Predictor	Pre-assessment
Other	VR experience, motivation, need for connection/relatedness, openness to experiences	Predictors - Each construct mentioned above will be measured on a single VAS	Pre-assessment
Other	Preference for treatment question	Predictor measured as a binary outcome	Pre-assessment
Other	Credibility and Expectancy Questionnaire (CEQ)	Predictor	1 week after pre-assessment*
Other	Working Alliance Inventory-Short Form (WAI-S)	Predictor	2 and 6 weeks after pre-assessment*
Other	Exposure log questions - expectancy violation & expectancy change	Mechanism - Measures related to threat expectancies (e.g., likelihood of threat expectancy, how bad it would be if it occurred) and threat occurrence (e.g., extent to which it occurred, surprise, relief, adjusted threat expectancy).; These variables will be collected prior to and after the exposure exercises and will be primarily assessed using visual analogue scales (VASs).	Weekly training sessions (up to 7 weeks after pre-assessment)*
Other	Exposure log open-ended questions - expectancy violation & expectancy change	Mechanism - open ended questions (e.g., what they learned, how they know that their threat expectancy did not occur) will also be asked to provide further context and to provide more insights into the participants' responses.	Weekly training sessions (up to 7 weeks after pre-assessment)*
Other	Exposure log questions - within- & between- session habituation	Mechanism - Subjective units of distress prior (anticipatory fear/anxiety) and after the exposure exercises (end fear/anxiety & peak fear/anxiety).; They will be measured using visual analogue scales (VASs)	Weekly training sessions (up to 7 weeks after pre-assessment)*
Other	Exposure log question- Self-efficacy	Mechanism - Visual analogue scale (VAS) measuring self-efficacy regarding handling social situations	Weekly training sessions (up to 7 weeks after pre-assessment)*
Other	Exposure log question - Presence	Mechanism - Only in the VRE condition a measure of presence (e.g., measuring how present they feel in the VR environment) will be collected for each exposure exercise.	Weekly training sessions (up to 7 weeks after pre-assessment)*
Other	Exposure log questions - Participant feedback	During each training session, visual analogue scales (VASs) will be administered to measure exercise difficulty, exercise usefulness/relevance, use of safety behaviors, and motivation to participate in the next session	Weekly training sessions (up to 7 weeks after pre-assessment)*
Other	Acceptability interview	A semi-structured interview will be conducted in a convenience sample of participants from both active conditions (e.g., 10 participants per condition) to investigate VRE's acceptability and to compare it to IVE.	Between post-assessment and first follow-up (between 8 and 20 weeks after pre-assessment)
Primary	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.
Primary	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)*
Primary	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	Brief Resilience Scale (BRS)	General measure of resilience	Pre-assessment, after 4 weeks, after 8 weeks, follow-up(after 20 weeks), follow up(after 32 weeks)*
Secondary	Multidimensional Adolescent Functioning Scale (MAFS) - Peer and General functioning subscales	General measure of psychosocial functioning	Pre-assessment, after 4 weeks, after 8 weeks, follow-up(after 20 weeks), follow up(after 32 weeks)*
Secondary	Revised Children's Anxiety and Depression Scale (RCADS)	General measure of depression and anxiety + Predictor	Pre-assessment, after 4 weeks, after 8 weeks, follow-up(after 20 weeks), follow up(after 32 weeks)*
Secondary	Self-Efficacy Questionnaire for Children (SEQ-C) - Social efficacy subscale	General measure of social self efficacy and mechanism	Pre-assessment, after 4 weeks, after 8 weeks, follow-up(after 20 weeks), follow up(after 32 weeks)*
Secondary	Social Phobia Weekly Summary Scale (SPWSS)	Weekly measure of social anxiety	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)*
Secondary	Liebowitz Social Anxiety Scale for Children and Adolescents (LSAS-CA) - Fear subscale	Secondary measure of fear regarding specific social situations	Pre-assessment, after 4 weeks, after 8 weeks, follow-up(after 20 weeks), follow up(after 32 weeks)*
Secondary	Adolescent Social Cognitions Questionnaire (ASCQ)	Secondary outcome and mechanism & predictor	Pre-assessment, after 8 weeks, follow-up(after 20 weeks), follow up(after 32 weeks)*
Secondary	Behavioral assessment task (BAT) - Anticipatory anxiety	Subjective units of distress (SUD) measured on a visual analogue scale (VAS) immediately before the BAT	Pre-assessment, after 8 weeks*
Secondary	Behavioral assessment task (BAT) - Physiological assessment	Mean heart rate measured during the BAT	Pre-assessment, after 8 weeks*
Secondary	Behavioral assessment task (BAT) - Physiological assessment	Heart-rate variability measured during the BAT	Pre-assessment, after 8 weeks*
Secondary	Behavioral assessment task (BAT) - Physiological assessment	Skin conductance response measured during the BAT	Pre-assessment, after 8 weeks*
Secondary	Behavioral assessment task (BAT) - Task duration	Duration of task in seconds	Pre-assessment, after 8 weeks*
Secondary	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	Pre-assessment, after 8 weeks*