Efficacy of Virtual Reality Exposure Therapy Scripts for Social Phobia

Study Overview
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Brief Summary
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The purpose of this study is to test the efficacy virtual reality videos to facilitate exposure therapy in social anxiety disorder (SAD). The exposure therapy videos are the focus of this experiment. Essentially, we are testing the efficacy of the Virtual Reality Exposure Therapy (VRET) scripts (i.e., virtual scenarios, people, and interactions that we expose socially anxious people to). To this end, the goal of the current study is to help people with social anxiety overcome their phobias. Individuals who experience a difficult time building social relationships, accomplishing everyday tasks, or pursuing job interviews can practice those same behaviors in a controlled environment. Specifically, we aim to test the following hypotheses: (1) Virtual reality exposure therapy intervention (vs. waitlist control condition) is effective for treating SAD symptoms. (2) Participants who received the VRET will experience maintenance of treatment gains following 3-month and 6-month post-termination of treatment. (3) Users of the virtual reality exposure therapy will demonstrate high amounts of acceptability of the treatment.

Official Title
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Efficacy of Using Real-Life Footage in Virtual Reality Exposure Therapy for Social Anxiety Disorder

Conditions
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Social Anxiety Disorder

Intervention / Treatment
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* Device: Pico Goblin VR headset


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presence of Social Anxiety Disorder based on the Social Phobia Diagnostic Questionnaire self-report or Mini International Neuropsychiatric Interview Current student at the Pennsylvania State University or a community-dwelling adult who expressed interest to participate through the PSU StudyFinder portal Expressed interest to seek treatment Currently not receiving treatment from a mental health professional Able to provide consent Proficient in English Exclusion Criteria: Below age 18 Failure to meet any of above inclusion criteria Presence of suicidality, mania, psychosis, or substance use disorders

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual reality exposure therapy<br>Participants were allowed to choose one of two themes. For both themes, each scene was developed to be more anxiety-provoking as the VRE progressed. Greater anxiety-inducing scenes had interviewers and other actors who displayed less compassionate, friendly, humorous, and pleasant verbal and non-verbal behaviors and demeanors to elicit elevated anxiety (Carless & Imber, 2007). Also, a virtual therapist was embedded within the VRE. It functioned to coach the participant through each distinct scene by orienting and prompting them to the exposure therapy task(s), continually conveying core principles of exposure therapy, and repeating the instructions if the participant was not responsive within five seconds. Each scene started with a paused video, during which participants were oriented by the virtual therapist to the context. | Device: Pico Goblin VR headset<br>* We worked with Limbix to tailor content on a Pico Goblin VR headset by creating two exposure therapy themes (general social skills training/dinner party or job interview) based on CBT principles and literature. The Pico Goblin VR headset projected a 5.5-inch diagonal screen size (depth: 139.7 mm; height: 122mm; width: 68mm) with 2560 x 1440-pixel resolution, 3 degrees of freedom, 92° field of view, a refresh rate of 70Hz, and 54-71mm interpupillary distance (Kyoto, 2017). It was chosen because displays of the pre-recorded VRE videos could be smoothly operated wirelessly with a tablet that showed the selected scenes in real-time. Further, the headset could be conveniently switched on and off, and dovetailed the participant's head motion. These scenes were filmed with a 360° stereoscopic camera, each lasting between 1.5 to 10 min.<br>|
| No Intervention: Waiting list<br>Participants started treatment 2-4 weeks post-randomization. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Social Anxiety Disorder at 2-8-week-post-randomization | Social Phobia Diagnostic Questionnaire-IV (SPDQ; Newman, Kachin, Zuellig, Constantino, & Cashman-McGrath, 2003) (21 of 21 items; self-report; possible range = 0-35). Social Interaction Anxiety Scale (SIAS; Mattick & Clarke, 1998) (20 of 20 items; self-report; possible range = 0-80). | Baseline, 2-8-week-post-randomization | 
| Change from Baseline Social Anxiety Disorder at 3-month post-randomization | Social Phobia Diagnostic Questionnaire-IV (SPDQ; Newman, Kachin, Zuellig, Constantino, & Cashman-McGrath, 2003) (21 of 21 items; self-report; possible range = 0-35). Social Interaction Anxiety Scale (SIAS; Mattick & Clarke, 1998) (20 of 20 items; self-report; possible range = 0-80). | Baseline, 3-month-post-randomization | 
| Change from Baseline Social Anxiety Disorder at 6-month post-randomization | Social Phobia Diagnostic Questionnaire-IV (SPDQ; Newman, Kachin, Zuellig, Constantino, & Cashman-McGrath, 2003) (21 of 21 items; self-report; possible range = 0-35). Social Interaction Anxiety Scale (SIAS; Mattick & Clarke, 1998) (20 of 20 items; self-report; possible range = 0-80). | Baseline, 6-month-post-randomization | 
| Change from Baseline Job Interview Anxiety at 2-8-week-post-randomization | Measure of Anxiety in Selection Interviews (MASI; McCarthy & Goffin, 2004) (30 of 30 items; self-report; possible range = 30-150) | Baseline, 2-8-week-post-randomization | 
| Change from Baseline Job Interview Anxiety at 3-month post-randomization | Measure of Anxiety in Selection Interviews (MASI; McCarthy & Goffin, 2004) (30 of 30 items; self-report; possible range = 30-150) | Baseline, 3-month post-randomization | 
| Change from Baseline Job Interview Anxiety at 6-month post-randomization | Measure of Anxiety in Selection Interviews (MASI; McCarthy & Goffin, 2004) (30 of 30 items; self-report; possible range = 30-150) | Baseline, 6-month post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Trait Worry Symptom Severity at 2-8-week-post-randomization | Penn State Worry Questionnaire (PSWQ; Meyer, Miller, Metzger, & Borkovec, 1990) (16 of 16 items; self-report; possible range = 16-80) | Baseline, 2-8-week-post-randomization | 
| Change from Baseline Trait Worry Symptom Severity at 3-month-post-randomization | Penn State Worry Questionnaire (PSWQ; Meyer, Miller, Metzger, & Borkovec, 1990) (16 of 16 items; self-report; possible range = 16-80) | Baseline, 3-month-post-randomization | 
| Change from Baseline Trait Worry Symptom Severity at 6-month-post-randomization | Penn State Worry Questionnaire (PSWQ; Meyer, Miller, Metzger, & Borkovec, 1990) (16 of 16 items; self-report; possible range = 16-80) | Baseline, 6-month-post-randomization | 
| Change from Baseline Depression Symptom Severity at 2-8-week-post-randomization | Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001) (9 of 9 items; self-report; possible range = 0-27) | Baseline, 2-8-week-post-randomization | 
| Change from Baseline Depression Symptom Severity at 3-month-post-randomization | Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001) (9 of 9 items; self-report; possible range = 0-27) | Baseline, 3-month-post-randomization | 
| Change from Baseline Depression Symptom Severity at 6-month-post-randomization | Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001) (9 of 9 items; self-report; possible range = 0-27) | Baseline, 6-month-post-randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual reality, Exposure therapy, Self-help