Virtual Reality Exposure for Socially Anxious Adolescents
- Conditions
- Social Anxiety
- Interventions
- Behavioral: In vivo exposureBehavioral: (Virtual reality) exposure
- Registration Number
- NCT06379633
- Lead Sponsor
- KU Leuven
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description In vivo exposure (IVE) In vivo exposure 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). Virtual reality exposure (VRE) (Virtual reality) exposure 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.
- Primary Outcome Measures
Name Time Method Brief version of the Social Phobia and Anxiety Inventory (SPAI-18) 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. General measure of social anxiety
Liebowitz Social Anxiety Scale for Children and Adolescents (LSAS-CA) - Avoidance subscale Pre-assessment, after 4 weeks, after 8 weeks, follow-up(after 20 weeks), follow up(after 32 weeks)* Avoidance measure of social anxiety
Behavioral assessment task (BAT) - Peak anxiety Pre-assessment, after 8 weeks* Subjective units of distress (SUD) measured on a visual analogue scale (VAS); administered immediately after the BAT
- Secondary Outcome Measures
Name Time Method 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)* General measure of social self efficacy and mechanism
Behavioral assessment task (BAT) - Physiological assessment Pre-assessment, after 8 weeks* Skin conductance response measured during the BAT
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)* General measure of psychosocial functioning
Liebowitz Social Anxiety Scale for Children and Adolescents (LSAS-CA) - Fear subscale Pre-assessment, after 4 weeks, after 8 weeks, follow-up(after 20 weeks), follow up(after 32 weeks)* Secondary measure of fear regarding specific social situations
Adolescent Social Cognitions Questionnaire (ASCQ) Pre-assessment, after 8 weeks, follow-up(after 20 weeks), follow up(after 32 weeks)* Secondary outcome and mechanism \& predictor
Behavioral assessment task (BAT) - Anticipatory anxiety Pre-assessment, after 8 weeks* Subjective units of distress (SUD) measured on a visual analogue scale (VAS) immediately before the BAT
Brief Resilience Scale (BRS) Pre-assessment, after 4 weeks, after 8 weeks, follow-up(after 20 weeks), follow up(after 32 weeks)* General measure of resilience
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)* General measure of depression and anxiety + Predictor
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)* Weekly measure of social anxiety
Behavioral assessment task (BAT) - Task duration Pre-assessment, after 8 weeks* Duration of task in seconds
Behavioral assessment task (BAT) - Confederate rating Pre-assessment, after 8 weeks* During the BAT, the confederate will rate the participants' social anxiety and performance on a 5-point Likert scale
Trial Locations
- Locations (1)
Psychological Institute (PSI) of KU Leuven
🇧🇪Leuven, Belgium