Efficacy of Virtual Reality Exposure Therapy Scripts for Social Phobia

Social Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04850989
• Other study ID #: STUDY00010344
• Status: Recruiting
• Phase: N/A
• Start date: December 18, 2018
• Est. completion date: December 31, 2027

Study information

• Verified date: April 2022
• Source: Penn State University
• Contact: Nur Hani Zainal, M.S.
• Phone: 917-767-7088
• Email: nvz5057[@]psu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobia, Social
• Social Anxiety Disorder

Intervention

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.

Locations

Country	Name	City	State
United States	The Pennsylvania State University	University Park	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Penn State University	Limbix Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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