Trial Outcomes & Findings for Efficacy of Virtual Reality Exposure Therapy Scripts for Social Phobia (NCT NCT04850989)
NCT ID: NCT04850989
Last Updated: 2025-05-13
Results Overview
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.
COMPLETED
NA
44 participants
Baseline and post-treatment, on average 2 weeks
2025-05-13
Participant Flow
Participant milestones
| Measure |
Virtual Reality Exposure Therapy (VRE)
We collaborated with a VR company, Limbix (https://www.limbix.com; now associated with BehaVR), that develops and provides VR-based mental health treatments (Paul, Bullock, \& Bailenson, 2020; Summers, Schwartzberg, \& Wilhelm, 2021). Specifically, we worked with Limbix to script the VR actors' verbal and non-verbal behaviors, virtual therapist's instructions, task prompts, and treatment rationale content in all scenes shown on a Pico Goblin VR headset. Two exposure therapy themes were created (informal dinner party or formal job interview) based on CBT principles and the literature. The headset displayed 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). The VRE also contained cutting-edge 360° stereoscopic views allowing for an omnidirectional range of visual perspective as participants could look in all directions within the virtual environment. It also contained dynamic video technology driven by machine learning optimization algorithms, biometrics, and programming rules (Lindner et al., 2019b; Lister et al., 2010). With respect to biometrics, it had the ability to detect voice output (e.g., a person not speaking served as a precondition to virtual therapist prompts to speak with the avatar).
|
Waitlist
Participants on the waitlist received the VRE treatment 4 weeks after the initial study visit.
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
18
|
|
Overall Study
COMPLETED
|
21
|
14
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy of Virtual Reality Exposure Therapy Scripts for Social Phobia
Baseline characteristics by cohort
| Measure |
Virtual Reality Exposure Therapy
n=26 Participants
Self-Guided Virtual Reality Exposure Therapy
|
Waitlist Control
n=18 Participants
Participants received the Virtual Reality Exposure Therapy after 2 weeks from the initial study visit.
|
Total
n=44 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
23.35 years
STANDARD_DEVIATION 8.63 • n=5 Participants
|
23.22 years
STANDARD_DEVIATION 10.51 • n=7 Participants
|
23.30 years
STANDARD_DEVIATION 9.32 • n=5 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Non-White
|
13 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White Caucasian
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Social Phobia Diagnostic Questionnaire (SPDQ)
|
19.12 units on a scale
STANDARD_DEVIATION 3.50 • n=5 Participants
|
16.99 units on a scale
STANDARD_DEVIATION 4.42 • n=7 Participants
|
18.06 units on a scale
STANDARD_DEVIATION 3.96 • n=5 Participants
|
|
Social Interaction Anxiety Scale (SIAS)
|
53.48 units on a scale
STANDARD_DEVIATION 9.53 • n=5 Participants
|
46.45 units on a scale
STANDARD_DEVIATION 14.54 • n=7 Participants
|
49.97 units on a scale
STANDARD_DEVIATION 12.04 • n=5 Participants
|
|
Measure of Anxiety in Selection Interviews (MASI)
|
74.87 units on a scale
STANDARD_DEVIATION 15.80 • n=5 Participants
|
70.46 units on a scale
STANDARD_DEVIATION 16.27 • n=7 Participants
|
72.67 units on a scale
STANDARD_DEVIATION 16.04 • n=5 Participants
|
|
Penn State Worry Questionnaire (PSWQ)
|
67.60 units on a scale
STANDARD_DEVIATION 6.92 • n=5 Participants
|
60.19 units on a scale
STANDARD_DEVIATION 7.81 • n=7 Participants
|
63.90 units on a scale
STANDARD_DEVIATION 7.37 • n=5 Participants
|
|
Patient Health Questionnaire (PHQ-9)
|
13.20 units on a scale
STANDARD_DEVIATION 5.80 • n=5 Participants
|
11.20 units on a scale
STANDARD_DEVIATION 6.01 • n=7 Participants
|
12.20 units on a scale
STANDARD_DEVIATION 5.91 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and post-treatment, on average 2 weeksPopulation: Intention-to-treat analysis
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.
Outcome measures
| Measure |
Virtual Reality Exposure Therapy
n=26 Participants
Participants engaged with the virtual reality exposure therapy designed to last four sessions or more.
|
Waitlist Control
n=18 Participants
Participants on the waitlist received the virtual reality exposure therapy four weeks post-randomization.
|
|---|---|---|
|
Change From Baseline in the Social Phobia Diagnostic Questionnaire (SPDQ) at Post-treatment
|
-9.60 score on a scale
Standard Deviation 0.01
|
-4.46 score on a scale
Standard Deviation 0.50
|
PRIMARY outcome
Timeframe: Baseline and post-treatment, on average 2 weeksPopulation: Intention-to-treat analysis
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.
Outcome measures
| Measure |
Virtual Reality Exposure Therapy
n=26 Participants
Participants engaged with the virtual reality exposure therapy designed to last four sessions or more.
|
Waitlist Control
n=18 Participants
Participants on the waitlist received the virtual reality exposure therapy four weeks post-randomization.
|
|---|---|---|
|
Change From Baseline in the Social Interaction Anxiety Scale (SIAS) at Post-treatment
|
-28.19 score on a scale
Standard Deviation 0.03
|
-16.65 score on a scale
Standard Deviation 1.26
|
SECONDARY outcome
Timeframe: Baseline and post-treatment, on average 2 weeksPopulation: Intention-to-treat analysis
The 30-item Measure of Anxiety in Selection Interviews (MASI; McCarthy \& Goffin, 2004) is a self-report designed to assess the severity of job interview anxiety across five dimensions: communication anxiety, appearance anxiety, social anxiety, performance anxiety, and behavioral anxiety. Each item is rated on a 5-point Likert scale ranging from 1 ("strongly disagree") to 5 ("strongly agree"), resulting in a total score range from 30 to 150, with higher scores indicating greater levels of interview anxiety. Change scores are calculated by subtracting the post-treatment score from the pre-treatment score, yielding a possible range from -120 to 120; larger negative change scores reflect a reduction in interview anxiety symptoms, thus indicating better outcomes.
Outcome measures
| Measure |
Virtual Reality Exposure Therapy
n=26 Participants
Participants engaged with the virtual reality exposure therapy designed to last four sessions or more.
|
Waitlist Control
n=18 Participants
Participants on the waitlist received the virtual reality exposure therapy four weeks post-randomization.
|
|---|---|---|
|
Change From Baseline in the Measure of Anxiety in Selection Interviews (MASI) at Post-treatment
|
-36.52 score on a scale
Standard Deviation 1.08
|
-22.57 score on a scale
Standard Deviation 6.21
|
SECONDARY outcome
Timeframe: Baseline and post-treatment, on average 2 weeksPopulation: Intention-to-treat analysis
The 16-item Penn State Worry Questionnaire (PSWQ; Meyer, Miller, Metzger, \& Borkovec, 1990) is a self-report instrument designed to assess the trait of pathological worry, a core feature of generalized anxiety disorder (GAD). Each item is rated on a 5-point Likert scale ranging from 1 ("not at all typical of me") to 5 ("very typical of me"), yielding total scores between 16 and 80. Higher scores indicate greater severity of worry. The PSWQ includes 11 items that directly assess worry and 5 reverse-scored items that measure the absence of worry, which must be recoded before computing the total score . In clinical trials, change scores are calculated by subtracting the post-treatment score from the pre-treatment score, resulting in a possible range from -64 to 64; larger negative change scores reflect a reduction in worry symptoms, thus indicating better outcomes.
Outcome measures
| Measure |
Virtual Reality Exposure Therapy
n=26 Participants
Participants engaged with the virtual reality exposure therapy designed to last four sessions or more.
|
Waitlist Control
n=18 Participants
Participants on the waitlist received the virtual reality exposure therapy four weeks post-randomization.
|
|---|---|---|
|
Change From Baseline in the Penn State Worry Questionnaire (PSWQ) at Post-treatment
|
-21.18 score on a scale
Standard Deviation 1.81
|
-13.10 score on a scale
Standard Deviation 0.10
|
SECONDARY outcome
Timeframe: Baseline and post-treatment, on average 2 weeksPopulation: Intention-to-treat analysis
The 9-item Patient Health Questionnaire (PHQ-9; Kroenke, Spitzer, \& Williams, 2001) is a self-administered instrument designed to assess the severity of depressive symptoms over the past two weeks, based on the diagnostic criteria outlined in the DSM-IV. Each item is rated on a 4-point Likert scale ranging from 0 ("Not at all") to 3 ("Nearly every day"), resulting in a total score that can range from 0 to 27. Higher scores correspond to more severe depressive symptoms, with established cutpoints indicating depression severity as follows: 0-4 (none or minimal), 5-9 (mild), 10-14 (moderate), 15-19 (moderately severe), and 20-27 (severe) . In clinical trials, change scores are calculated by subtracting the post-treatment score from the pre-treatment score, yielding a possible range from -27 to 27; positive change scores reflect a reduction in depressive symptoms, indicating better outcomes.
Outcome measures
| Measure |
Virtual Reality Exposure Therapy
n=26 Participants
Participants engaged with the virtual reality exposure therapy designed to last four sessions or more.
|
Waitlist Control
n=18 Participants
Participants on the waitlist received the virtual reality exposure therapy four weeks post-randomization.
|
|---|---|---|
|
Change From Baseline in the Patient Health Questionnaire (PHQ-9) at Post-treatment
|
-6.74 score on a scale
Standard Deviation 2.69
|
-3.26 score on a scale
Standard Deviation 2.41
|
Adverse Events
Virtual Reality Exposure Therapy
Waiting List
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place