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Efficacy of Virtual Reality Exposure Therapy Scripts for Social Phobia

Primary Purpose

Social Anxiety Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pico Goblin VR headset
Sponsored by
Penn State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Social Anxiety Disorder focused on measuring Virtual reality, Exposure therapy, Self-help

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Pennsylvania State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Virtual reality exposure therapy

Waiting list

Arm Description

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.

Participants started treatment 2-4 weeks post-randomization.

Outcomes

Primary Outcome Measures

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).
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).
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).
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)
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)
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)

Secondary Outcome Measures

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)
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)
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)
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)
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)
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)

Full Information

First Posted
April 9, 2021
Last Updated
April 18, 2022
Sponsor
Penn State University
Collaborators
Limbix Health, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04850989
Brief Title
Efficacy of Virtual Reality Exposure Therapy Scripts for Social Phobia
Official Title
Efficacy of Using Real-Life Footage in Virtual Reality Exposure Therapy for Social Anxiety Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 18, 2018 (Actual)
Primary Completion Date
December 31, 2025 (Anticipated)
Study Completion Date
December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Penn State University
Collaborators
Limbix Health, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety Disorder
Keywords
Virtual reality, Exposure therapy, Self-help

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Virtual reality exposure therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Waiting list
Arm Type
No Intervention
Arm Description
Participants started treatment 2-4 weeks post-randomization.
Intervention Type
Device
Intervention Name(s)
Pico Goblin VR headset
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from Baseline Social Anxiety Disorder at 2-8-week-post-randomization
Description
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).
Time Frame
Baseline, 2-8-week-post-randomization
Title
Change from Baseline Social Anxiety Disorder at 3-month post-randomization
Description
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).
Time Frame
Baseline, 3-month-post-randomization
Title
Change from Baseline Social Anxiety Disorder at 6-month post-randomization
Description
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).
Time Frame
Baseline, 6-month-post-randomization
Title
Change from Baseline Job Interview Anxiety at 2-8-week-post-randomization
Description
Measure of Anxiety in Selection Interviews (MASI; McCarthy & Goffin, 2004) (30 of 30 items; self-report; possible range = 30-150)
Time Frame
Baseline, 2-8-week-post-randomization
Title
Change from Baseline Job Interview Anxiety at 3-month post-randomization
Description
Measure of Anxiety in Selection Interviews (MASI; McCarthy & Goffin, 2004) (30 of 30 items; self-report; possible range = 30-150)
Time Frame
Baseline, 3-month post-randomization
Title
Change from Baseline Job Interview Anxiety at 6-month post-randomization
Description
Measure of Anxiety in Selection Interviews (MASI; McCarthy & Goffin, 2004) (30 of 30 items; self-report; possible range = 30-150)
Time Frame
Baseline, 6-month post-randomization
Secondary Outcome Measure Information:
Title
Change from Baseline Trait Worry Symptom Severity at 2-8-week-post-randomization
Description
Penn State Worry Questionnaire (PSWQ; Meyer, Miller, Metzger, & Borkovec, 1990) (16 of 16 items; self-report; possible range = 16-80)
Time Frame
Baseline, 2-8-week-post-randomization
Title
Change from Baseline Trait Worry Symptom Severity at 3-month-post-randomization
Description
Penn State Worry Questionnaire (PSWQ; Meyer, Miller, Metzger, & Borkovec, 1990) (16 of 16 items; self-report; possible range = 16-80)
Time Frame
Baseline, 3-month-post-randomization
Title
Change from Baseline Trait Worry Symptom Severity at 6-month-post-randomization
Description
Penn State Worry Questionnaire (PSWQ; Meyer, Miller, Metzger, & Borkovec, 1990) (16 of 16 items; self-report; possible range = 16-80)
Time Frame
Baseline, 6-month-post-randomization
Title
Change from Baseline Depression Symptom Severity at 2-8-week-post-randomization
Description
Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001) (9 of 9 items; self-report; possible range = 0-27)
Time Frame
Baseline, 2-8-week-post-randomization
Title
Change from Baseline Depression Symptom Severity at 3-month-post-randomization
Description
Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001) (9 of 9 items; self-report; possible range = 0-27)
Time Frame
Baseline, 3-month-post-randomization
Title
Change from Baseline Depression Symptom Severity at 6-month-post-randomization
Description
Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, & Williams, 2001) (9 of 9 items; self-report; possible range = 0-27)
Time Frame
Baseline, 6-month-post-randomization
Other Pre-specified Outcome Measures:
Title
Mental health disorder screening measures
Description
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.
Time Frame
Baseline
Title
Process measures
Description
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.
Time Frame
Baseline, 2-8-week-post-randomization
Title
Treatment acceptability
Description
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.
Time Frame
2-8-week-post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nur Hani Zainal, M.S.
Phone
917-767-7088
Email
nvz5057@psu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle G. Newman, Ph.D.
Phone
814-883-4572
Email
mgn1@psu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle G. Newman, Ph.D.
Organizational Affiliation
The Pennsylvania State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Pennsylvania State University
City
University Park
State/Province
Pennsylvania
ZIP/Postal Code
16802
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle G. Newman, Ph.D.
Phone
814-883-4572
Email
mgn1@psu.edu
First Name & Middle Initial & Last Name & Degree
Michelle G. Newman, Ph.D.

12. IPD Sharing Statement

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Efficacy of Virtual Reality Exposure Therapy Scripts for Social Phobia

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