Trial Outcomes & Findings for A Randomized, Controlled Study of Two At-Home Self-Guided Virtual Reality Interventions for Adults With Social Anxiety Disorder. (NCT NCT06037668)
NCT ID: NCT06037668
Last Updated: 2025-03-12
Results Overview
The Credibility/Expectation Questionnaire (CEQ) asks about the improvements that subjects believe will be achieved as a result of treatment, and how believable, convincing,and logical the treatment seems.It contains six items rated on a 1-9 scale. The first three items load onto the credibility factor. Higher scores suggest better experience, lower scores suggest poor experience.Credibility score is calculated by taking the sum of score of the first 3 items of the CEQ scale ranging from 3 to 27.
COMPLETED
NA
56 participants
Baseline
2025-03-12
Participant Flow
Participant milestones
| Measure |
BVR-100
Experimental at-home VR intervention for the treatment of SAD
|
BES-100
Active at-home VR intervention comparator
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
28
|
|
Overall Study
COMPLETED
|
24
|
27
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
Reasons for withdrawal
| Measure |
BVR-100
Experimental at-home VR intervention for the treatment of SAD
|
BES-100
Active at-home VR intervention comparator
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Other Study Discontinuation Reason
|
1
|
0
|
Baseline Characteristics
ITT Population
Baseline characteristics by cohort
| Measure |
BVR-100
n=25 Participants
Experimental at-home VR intervention for the treatment of SAD
|
BES-100
n=27 Participants
Active at-home VR intervention comparator
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=25 Participants • ITT Population
|
0 Participants
n=27 Participants • ITT Population
|
0 Participants
n=52 Participants • ITT Population
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=25 Participants • ITT Population
|
25 Participants
n=27 Participants • ITT Population
|
50 Participants
n=52 Participants • ITT Population
|
|
Age, Categorical
>=65 years
|
0 Participants
n=25 Participants • ITT Population
|
2 Participants
n=27 Participants • ITT Population
|
2 Participants
n=52 Participants • ITT Population
|
|
Sex: Female, Male
Female
|
15 Participants
n=25 Participants • ITT Population
|
25 Participants
n=27 Participants • ITT Population
|
40 Participants
n=52 Participants • ITT Population
|
|
Sex: Female, Male
Male
|
10 Participants
n=25 Participants • ITT Population
|
2 Participants
n=27 Participants • ITT Population
|
12 Participants
n=52 Participants • ITT Population
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=25 Participants • ITT Population
|
3 Participants
n=27 Participants • ITT Population
|
5 Participants
n=52 Participants • ITT Population
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=25 Participants • ITT Population
|
22 Participants
n=27 Participants • ITT Population
|
44 Participants
n=52 Participants • ITT Population
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=25 Participants • ITT Population
|
2 Participants
n=27 Participants • ITT Population
|
3 Participants
n=52 Participants • ITT Population
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=25 Participants • ITT Population
|
0 Participants
n=27 Participants • ITT Population
|
1 Participants
n=52 Participants • ITT Population
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=25 Participants • ITT Population
|
0 Participants
n=27 Participants • ITT Population
|
2 Participants
n=52 Participants • ITT Population
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants • ITT Population
|
0 Participants
n=27 Participants • ITT Population
|
0 Participants
n=52 Participants • ITT Population
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=25 Participants • ITT Population
|
4 Participants
n=27 Participants • ITT Population
|
6 Participants
n=52 Participants • ITT Population
|
|
Race (NIH/OMB)
White
|
20 Participants
n=25 Participants • ITT Population
|
22 Participants
n=27 Participants • ITT Population
|
42 Participants
n=52 Participants • ITT Population
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=25 Participants • ITT Population
|
1 Participants
n=27 Participants • ITT Population
|
1 Participants
n=52 Participants • ITT Population
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=25 Participants • ITT Population
|
0 Participants
n=27 Participants • ITT Population
|
0 Participants
n=52 Participants • ITT Population
|
|
Region of Enrollment
United States
|
25 Participants
n=25 Participants • ITT Population
|
27 Participants
n=27 Participants • ITT Population
|
52 Participants
n=52 Participants • ITT Population
|
|
Baseline Credibility/Expectancy score
|
35.1 units on a scale
STANDARD_DEVIATION 8.13 • n=18 Participants • ITT Population
|
30.2 units on a scale
STANDARD_DEVIATION 6.58 • n=14 Participants • ITT Population
|
32.9 units on a scale
STANDARD_DEVIATION 7.77 • n=32 Participants • ITT Population
|
|
Baseline Credibility score
|
18 units on a scale
STANDARD_DEVIATION 4.31 • n=18 Participants • ITT Population
|
15.4 units on a scale
STANDARD_DEVIATION 4.57 • n=14 Participants • ITT Population
|
16.9 units on a scale
STANDARD_DEVIATION 4.54 • n=32 Participants • ITT Population
|
|
Baseline Expectancy score
|
17.1 units on a scale
STANDARD_DEVIATION 4.43 • n=18 Participants • ITT Population
|
14.8 units on a scale
STANDARD_DEVIATION 3.24 • n=14 Participants • ITT Population
|
16.1 units on a scale
STANDARD_DEVIATION 4.06 • n=32 Participants • ITT Population
|
PRIMARY outcome
Timeframe: BaselinePopulation: ITT Population who had measurement of Credibility / Expectancy Score completed at Baseline
The Credibility/Expectation Questionnaire (CEQ) asks about the improvements that subjects believe will be achieved as a result of treatment, and how believable, convincing,and logical the treatment seems.It contains six items rated on a 1-9 scale. The first three items load onto the credibility factor. Higher scores suggest better experience, lower scores suggest poor experience.Credibility score is calculated by taking the sum of score of the first 3 items of the CEQ scale ranging from 3 to 27.
Outcome measures
| Measure |
BVR-100
n=18 Participants
Experimental at-home VR intervention for the treatment of SAD
|
BES-100
n=14 Participants
Active at-home VR intervention comparator
|
|---|---|---|
|
Measurement of Intervention Credibility Assessed With the Credibility Score, at Baseline
|
18 units on a scale
Standard Deviation 4.31
|
15.4 units on a scale
Standard Deviation 4.57
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: ITT Population who had measurement of Credibility / Expectancy Score completed at Week 6
The Credibility/Expectation Questionnaire (CEQ) asks about the improvements that subjects believe will be achieved as a result of treatment, and how believable, convincing,and logical the treatment seems.It contains six items rated on a 1-9 scale. The first three items load onto the credibility factor. Higher scores suggest better experience, lower scores suggest poor experience.Credibility score is calculated by taking the sum of score of the first 3 items of the CEQ scale ranging from 3 to 27.
Outcome measures
| Measure |
BVR-100
n=17 Participants
Experimental at-home VR intervention for the treatment of SAD
|
BES-100
n=17 Participants
Active at-home VR intervention comparator
|
|---|---|---|
|
Measurement of Intervention Credibility Assessed With the Credibility Score, at Week 6
|
18.9 units on a scale
Standard Deviation 5.37
|
12.3 units on a scale
Standard Deviation 6.56
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: ITT Population who had measurement of Credibility / Expectancy Score completed at Week 8
The Credibility/Expectation Questionnaire (CEQ) asks about the improvements that subjects believe will be achieved as a result of treatment, and how believable, convincing,and logical the treatment seems.It contains six items rated on a 1-9 scale. The first three items load onto the credibility factor. Higher scores suggest better experience, lower scores suggest poor experience.Credibility score is calculated by taking the sum of score of the first 3 items of the CEQ scale ranging from 3 to 27.
Outcome measures
| Measure |
BVR-100
n=15 Participants
Experimental at-home VR intervention for the treatment of SAD
|
BES-100
n=19 Participants
Active at-home VR intervention comparator
|
|---|---|---|
|
Measurement of Intervention Credibility Assessed With the Credibility Score, at Week 8
|
18.7 units on a scale
Standard Deviation 6.31
|
13.7 units on a scale
Standard Deviation 7.68
|
PRIMARY outcome
Timeframe: BaselinePopulation: ITT Population who had measurement of Credibility / Expectancy Score completed at Baseline
The Credibility/Expectation Questionnaire (CEQ) asks about the improvements that subjects believe will be achieved as a result of treatment, and how believable, convincing,and logical the treatment seems.It contains six items rated on a 1-9 scale. The final three items load onto the expectancy factor. Higher scores suggest better experience, lower scores suggest poor experience.Expectancy score is calculated by taking the sum of score of the last 3 items of the CEQ scale ranging from 3 to 27.
Outcome measures
| Measure |
BVR-100
n=18 Participants
Experimental at-home VR intervention for the treatment of SAD
|
BES-100
n=14 Participants
Active at-home VR intervention comparator
|
|---|---|---|
|
Measurement of Intervention Credibility Assessed With Expectancy Score, at Baseline
|
17.1 units on a scale
Standard Deviation 4.43
|
14.8 units on a scale
Standard Deviation 3.24
|
PRIMARY outcome
Timeframe: 6 weeksPopulation: ITT Population who had measurement of Credibility / Expectancy Score completed at Week 6
The Credibility/Expectation Questionnaire (CEQ) asks about the improvements that subjects believe will be achieved as a result of treatment, and how believable, convincing,and logical the treatment seems.It contains six items rated on a 1-9 scale. The final three items load onto the expectancy factor. Higher scores suggest better experience, lower scores suggest poor experience.Expectancy score is calculated by taking the sum of score of the last 3 items of the CEQ scale ranging from 3 to 27.
Outcome measures
| Measure |
BVR-100
n=17 Participants
Experimental at-home VR intervention for the treatment of SAD
|
BES-100
n=17 Participants
Active at-home VR intervention comparator
|
|---|---|---|
|
Measurement of Intervention Credibility Assessed With the Expectancy Score, at Week 6
|
15.4 units on a scale
Standard Deviation 5.75
|
11.6 units on a scale
Standard Deviation 7.14
|
PRIMARY outcome
Timeframe: 8 weeksPopulation: ITT Population who had measurement of Credibility / Expectancy Score completed at Week 8
The Credibility/Expectation Questionnaire (CEQ) asks about the improvements that subjects believe will be achieved as a result of treatment, and how believable, convincing,and logical the treatment seems.It contains six items rated on a 1-9 scale. The final three items load onto the expectancy factor. Higher scores suggest better experience, lower scores suggest poor experience.Expectancy score is calculated by taking the sum of score of the last 3 items of the CEQ scale ranging from 3 to 27.
Outcome measures
| Measure |
BVR-100
n=15 Participants
Experimental at-home VR intervention for the treatment of SAD
|
BES-100
n=19 Participants
Active at-home VR intervention comparator
|
|---|---|---|
|
Measurement of Intervention Credibility Assessed With the ExpectancyScore, at Week 8
|
15.3 units on a scale
Standard Deviation 6.21
|
13.6 units on a scale
Standard Deviation 7.47
|
SECONDARY outcome
Timeframe: 6 weeksPopulation: ITT Population
Subject retention in each group were assessed by percentage of subjects who remain on the study at Week 6
Outcome measures
| Measure |
BVR-100
n=24 Participants
Experimental at-home VR intervention for the treatment of SAD
|
BES-100
n=27 Participants
Active at-home VR intervention comparator
|
|---|---|---|
|
Subject Retention Rate at Week 6
|
96 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: ITT Population
Subject retention in each group were assessed by percentage of subjects who remain on the study at Week 8
Outcome measures
| Measure |
BVR-100
n=24 Participants
Experimental at-home VR intervention for the treatment of SAD
|
BES-100
n=27 Participants
Active at-home VR intervention comparator
|
|---|---|---|
|
Subject Retention Rate at Week 8
|
96 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: 8 weeksPopulation: ITT Population
Time-on-task, averaged over all VR sessions from baseline to Week 8/EOS. Time on task will be automatically recorded by the VR system after each session.
Outcome measures
| Measure |
BVR-100
n=25 Participants
Experimental at-home VR intervention for the treatment of SAD
|
BES-100
n=27 Participants
Active at-home VR intervention comparator
|
|---|---|---|
|
Summary of Time-on-Task
|
4.97 minutes
Standard Deviation 1.886
|
6.59 minutes
Standard Deviation 0.359
|
Adverse Events
BVR-100
BES-100
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BVR-100
n=25 participants at risk
Experimental at-home VR intervention for the treatment of SAD
|
BES-100
n=27 participants at risk
Active at-home VR intervention comparator
|
|---|---|---|
|
Infections and infestations
COVID-19
|
8.0%
2/25 • Number of events 2 • Up to 8 Weeks
|
0.00%
0/27 • Up to 8 Weeks
|
|
Nervous system disorders
Dizziness
|
8.0%
2/25 • Number of events 2 • Up to 8 Weeks
|
0.00%
0/27 • Up to 8 Weeks
|
Additional Information
Director, Frontier Business Office
Sumitomo Pharma America
Results disclosure agreements
- Principal investigator is a sponsor employee In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.
- Publication restrictions are in place
Restriction type: OTHER