Clinical trial NCT06379633: Virtual Reality Exposure for Socially Anxious Adolescents
Official title: Virtual Reality Exposure for Socially Anxious Adolescents: A Randomized Controlled Trial (RCT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Social Anxiety
Keywords: virtual reality exposure
social anxiety
adolescents
inhibitory learning theory
predictors
youth
mental health
mechanisms
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Utrecht University
First posted: 2024-04-23
Enrollment: 120
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of the three conditions and will remain in that condition throughout the training sessions.
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Brief version of the Social Phobia and Anxiety Inventory (SPAI-18)
timeFrame: 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.
measure: Liebowitz Social Anxiety Scale for Children and Adolescents (LSAS-CA) - Avoidance subscale
timeFrame: Pre-assessment, after 4 weeks, after 8 weeks, follow-up(after 20 weeks), follow up(after 32 weeks)*
measure: Behavioral assessment task (BAT) - Peak anxiety
timeFrame: Pre-assessment, after 8 weeks*
Secondary outcomes:
measure: Brief Resilience Scale (BRS)
timeFrame: Pre-assessment, after 4 weeks, after 8 weeks, follow-up(after 20 weeks), follow up(after 32 weeks)*
measure: Multidimensional Adolescent Functioning Scale (MAFS) - Peer and General functioning subscales
timeFrame: Pre-assessment, after 4 weeks, after 8 weeks, follow-up(after 20 weeks), follow up(after 32 weeks)*
measure: Revised Children's Anxiety and Depression Scale (RCADS)
timeFrame: Pre-assessment, after 4 weeks, after 8 weeks, follow-up(after 20 weeks), follow up(after 32 weeks)*
measure: Self-Efficacy Questionnaire for Children (SEQ-C) - Social efficacy subscale
timeFrame: Pre-assessment, after 4 weeks, after 8 weeks, follow-up(after 20 weeks), follow up(after 32 weeks)*
measure: Social Phobia Weekly Summary Scale (SPWSS)
timeFrame: 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)*
measure: Liebowitz Social Anxiety Scale for Children and Adolescents (LSAS-CA) - Fear subscale
timeFrame: Pre-assessment, after 4 weeks, after 8 weeks, follow-up(after 20 weeks), follow up(after 32 weeks)*
measure: Adolescent Social Cognitions Questionnaire (ASCQ)
timeFrame: Pre-assessment, after 8 weeks, follow-up(after 20 weeks), follow up(after 32 weeks)*
measure: Behavioral assessment task (BAT) - Anticipatory anxiety
timeFrame: Pre-assessment, after 8 weeks*
measure: Behavioral assessment task (BAT) - Physiological assessment
timeFrame: Pre-assessment, after 8 weeks*
measure: Behavioral assessment task (BAT) - Physiological assessment
timeFrame: Pre-assessment, after 8 weeks*
measure: Behavioral assessment task (BAT) - Physiological assessment
timeFrame: Pre-assessment, after 8 weeks*
measure: Behavioral assessment task (BAT) - Task duration
timeFrame: Pre-assessment, after 8 weeks*
measure: Behavioral assessment task (BAT) - Confederate rating
timeFrame: Pre-assessment, after 8 weeks*
Other outcomes:
measure: Behavioral inhibition system / behavioral activation system scale (BIS/BAS)
timeFrame: Pre-assessment
measure: Experiences in Close Relationship Scale - Relationship Structures (ECR-RS)
timeFrame: Pre-assessment
measure: Immersive Tendency Questionnaire (ITQ) - Factor Involvement
timeFrame: Pre-assessment
measure: Unified Theory of Acceptance and Use of Technology (UTAUT-A) - Attitudes subscale
timeFrame: Pre-assessment
measure: Unified Theory of Acceptance and Use of Technology (UTAUT-EC) - Expectancy subscale
timeFrame: Pre-assessment
measure: VR experience, motivation, need for connection/relatedness, openness to experiences
timeFrame: Pre-assessment
measure: Preference for treatment question
timeFrame: Pre-assessment
measure: Credibility and Expectancy Questionnaire (CEQ)
timeFrame: 1 week after pre-assessment*
measure: Working Alliance Inventory-Short Form (WAI-S)
timeFrame: 2 and 6 weeks after pre-assessment*
measure: Exposure log questions - expectancy violation & expectancy change
timeFrame: Weekly training sessions (up to 7 weeks after pre-assessment)*
measure: Exposure log open-ended questions - expectancy violation & expectancy change
timeFrame: Weekly training sessions (up to 7 weeks after pre-assessment)*
measure: Exposure log questions - within- & between- session habituation
timeFrame: Weekly training sessions (up to 7 weeks after pre-assessment)*
measure: Exposure log question- Self-efficacy
timeFrame: Weekly training sessions (up to 7 weeks after pre-assessment)*
measure: Exposure log question - Presence
timeFrame: Weekly training sessions (up to 7 weeks after pre-assessment)*
measure: Exposure log questions - Participant feedback
timeFrame: Weekly training sessions (up to 7 weeks after pre-assessment)*
measure: Acceptability interview
timeFrame: Between post-assessment and first follow-up (between 8 and 20 weeks after pre-assessment)
Locations:
city: Leuven
country: Belgium
facility: Psychological Institute (PSI) of KU Leuven
Study officials:
affiliation: KU Leuven
name: Dirk Hermans, PhD
role: PRINCIPAL_INVESTIGATOR
References: