Efficacy of Virtual Reality Exposure Therapy Scripts for Social Phobia

NCT04850989 | Completed Results FDA Device

• 1 other identifier: STUDY00010344
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Social Anxiety Disorder

Keywords

Virtual reality; Exposure therapy; Self-help

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in the Social Phobia Diagnostic Questionnaire (SPDQ) at Post-treatment

  The 25-item Diagnostic and Statistical Manual-Fourth Edition-Text Revised (DSM-IV-TR)-aligned Social Phobia Diagnostic Questionnaire (SPDQ; Newman, Kachin, Zuellig, Constantino, \& Cashman-McGrath, 2003) is a self-report instrument designed to assess the degree of fear and avoidance associated with various social situations. Each item evaluates the severity of fear and the frequency of avoidance on a 5-point Likert scale, where 0 indicates "no fear" or "never avoid," and 4 signifies "very severe fear" or "always avoid" . The total score is derived by summing the responses across all items, yielding a range from 0 to 27, with higher scores reflecting greater social anxiety symptoms . In clinical trials, change scores are calculated by subtracting post-treatment scores from baseline scores, resulting in a possible range from -27 to 27; higher (less negative) change scores indicate better outcomes, signifying a reduction in social anxiety symptoms.

  Baseline and post-treatment, on average 2 weeks

• Change From Baseline in the Social Interaction Anxiety Scale (SIAS) at Post-treatment

  The 20-item Social Interaction Anxiety Scale (SIAS; Mattick \& Clarke, 1998) is a self-report instrument designed to assess the severity of social anxiety disorder (SAD) symptoms, particularly focusing on distress experienced during social interactions. Each item is rated on a 5-point Likert scale ranging from 0 ("not at all characteristic or true of me") to 4 ("extremely characteristic or true of me"), yielding a total score between 0 and 80. Notably, items 5, 9, and 11 are reverse-scored. Higher total scores indicate greater levels of social interaction anxiety. Clinically, a total score of 36 or above suggests probable social anxiety disorder, while a score of 43 or higher indicates SAD. Change scores are calculated by subtracting the post-treatment score from the pre-treatment score, resulting in a possible range from -80 to 80. Negative change scores (i.e., a decrease in total SIAS score) reflect a reduction in social anxiety symptoms, thus indicating better outcomes.

  Baseline and post-treatment, on average 2 weeks

Secondary Outcomes (3)

• Change From Baseline in the Measure of Anxiety in Selection Interviews (MASI) at Post-treatment

  Baseline and post-treatment, on average 2 weeks

• Change From Baseline in the Penn State Worry Questionnaire (PSWQ) at Post-treatment

  Baseline and post-treatment, on average 2 weeks

• Change From Baseline in the Patient Health Questionnaire (PHQ-9) at Post-treatment

  Baseline and post-treatment, on average 2 weeks

Study Arms (2)

Virtual reality exposure therapy

EXPERIMENTAL

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

Waiting list

NO INTERVENTION

Participants started treatment 2-4 weeks post-randomization.

Interventions

Pico Goblin VR headset DEVICE

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.

Virtual reality exposure therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Below age 18
• Presence of suicidality, mania, psychosis, or substance use disorders

Sponsors & Collaborators

• Penn State University: lead
• Limbix Health, Inc.: collaborator

Study Sites (1)

The Pennsylvania State University

University Park, Pennsylvania, 16802, United States

Location

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Results Point of Contact

• Title: Nur Hani Zainal
• Organization: National University of Singapore

hanizainal@nus.edu.sg

+65 6516 3749

Study Officials

• Michelle G. Newman, Ph.D.

  The Pennsylvania State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Model Details: Refer to published trial.

Study Record Dates

• First Submitted: April 9, 2021
• First Posted: April 20, 2021
• Study Start: December 18, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: May 13, 2025
• Results First Posted: May 13, 2025

Record last verified: 2025-05

Locations

US (1)