Efficacy of Virtual Reality Exposure Therapy Scripts for Social Phobia

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

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.

Study Overview

• Status: Recruiting
• Conditions: Social Anxiety Disorder
• Intervention / Treatment: Device: Pico Goblin VR headset

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nur Hani Zainal, M.S.; Phone Number: 917-767-7088; Email: nvz5057@psu.edu
• Study Contact Backup: Name: Michelle G. Newman, Ph.D.; Phone Number: 814-883-4572; Email: mgn1@psu.edu

Study Locations

• United States
  • Pennsylvania
    • University Park, Pennsylvania, United States, 16802
      • Recruiting
      • The Pennsylvania State University
      • Contact: Michelle G. Newman, Ph.D.; Phone Number: 814-883-4572; Email: mgn1@psu.edu
      • Principal Investigator: Michelle G. Newman, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual reality exposure therapy; 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; 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.
No Intervention: Waiting list; Participants started treatment 2-4 weeks post-randomization.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mental health disorder screening measures	Social anxiety disorder assessed using the Social Phobia Diagnostic Questionnaire (SPDQ; Newman, Kachin, Zuellig, Constantino, & Cashman-McGrath, 2003). Mental health disorders (generalized anxiety disorder, generalized anxiety disorder, major depressive disorder, manic and hypomanic episodes, agoraphobia, panic disorder, post-traumatic stress disorder, alcohol use disorder, substance use disorder, anorexia nervosa, bulimia nervosa, binge eating disorder), as well as rule out organic, drug, or medical causes of mental health problems were determined with the Mini International Neuropsychiatric Interview (MINI) (Sheehan et al., 1997) Version 7.0.0.	Baseline
Process measures	Acceptability was measured by asking participants if they would be willing to recommend the program to others who might have problems similar to theirs and for their feedback.	Baseline, 2-8-week-post-randomization
Treatment acceptability	Acceptability was measured by asking participants if they would be willing to recommend the program to others who might have problems similar to theirs and for their feedback.	2-8-week-post-randomization

Collaborators and Investigators

• Sponsor: Penn State University
• Collaborators: Limbix Health, Inc.
• Investigators: Principal Investigator: Michelle G. Newman, Ph.D., The Pennsylvania State University

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2018
• Primary Completion (Anticipated): December 31, 2025
• Study Completion (Anticipated): December 31, 2027

Study Registration Dates

• First Submitted: April 9, 2021
• First Submitted That Met QC Criteria: April 14, 2021
• First Posted (Actual): April 20, 2021

Study Record Updates

• Last Update Posted (Actual): April 25, 2022
• Last Update Submitted That Met QC Criteria: April 18, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: Self-help; Virtual reality; Exposure therapy
• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Anxiety Disorders; Phobia, Social
• Other Study ID Numbers: STUDY00010344

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes