Trial Outcomes & Findings for Virtual Reality System for Anxiety and OCD (NCT NCT03636022)
NCT ID: NCT03636022
Last Updated: 2024-10-15
Results Overview
The SUDS - 0 to 10 ratings, where 0 indicates that participants feel no anxiety at all and 10 indicates that participants are experiencing maximum distress. The mean change in SUDS during the Session VR exposure versus mean change in SUDS during the conventional (control condition) verbal imaginal exposure.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
45 participants
Primary outcome timeframe
Baseline and End of Session I, 2 hours
Results posted on
2024-10-15
Participant Flow
Participant milestones
| Measure |
VR System
Participants will then be assigned one week of daily exposure homework. Patients randomized to the intervention condition will take home the VR system for homework.
VR System: Use of virtual reality to deliver exposure therapy
|
Control Condition
Participants will then be assigned one week of daily exposure homework. Participants assigned to control will be instructed to complete imaginal exposures.
Control: Use of conventional delivery of exposure therapy
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
20
|
|
Overall Study
COMPLETED
|
24
|
17
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
| Measure |
VR System
Participants will then be assigned one week of daily exposure homework. Patients randomized to the intervention condition will take home the VR system for homework.
VR System: Use of virtual reality to deliver exposure therapy
|
Control Condition
Participants will then be assigned one week of daily exposure homework. Participants assigned to control will be instructed to complete imaginal exposures.
Control: Use of conventional delivery of exposure therapy
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
Baseline Characteristics
Virtual Reality System for Anxiety and OCD
Baseline characteristics by cohort
| Measure |
VR System
n=25 Participants
Participants will then be assigned one week of daily exposure homework. Patients randomized to the intervention condition will take home the VR system for homework.
VR System: Use of virtual reality to deliver exposure therapy
|
Control Condition
n=20 Participants
Participants will then be assigned one week of daily exposure homework. Participants assigned to control will be instructed to complete imaginal exposures.
Control: Use of conventional delivery of exposure therapy
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
13.3 years
STANDARD_DEVIATION 2.6 • n=5 Participants
|
13.1 years
STANDARD_DEVIATION 3.0 • n=7 Participants
|
13.2 years
STANDARD_DEVIATION 2.8 • n=5 Participants
|
|
Sex/Gender, Customized
Gender at Birth · Female
|
21 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender at Birth · Male
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
22 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 participants
n=5 Participants
|
20 participants
n=7 Participants
|
45 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and End of Session I, 2 hoursThe SUDS - 0 to 10 ratings, where 0 indicates that participants feel no anxiety at all and 10 indicates that participants are experiencing maximum distress. The mean change in SUDS during the Session VR exposure versus mean change in SUDS during the conventional (control condition) verbal imaginal exposure.
Outcome measures
| Measure |
VR System
n=24 Participants
Participants will then be assigned one week of daily exposure homework. Patients randomized to the intervention condition will take home the VR system for homework.
VR System: Use of virtual reality to deliver exposure therapy
|
Control Condition
n=17 Participants
Participants will then be assigned one week of daily exposure homework. Participants assigned to control will be instructed to complete imaginal exposures.
Control: Use of conventional delivery of exposure therapy
|
|---|---|---|
|
Mean Change From Baseline in Subjective Units of Distress Scale (SUDS) at End of Session 1
|
-3.7 units on a scale
Standard Deviation 2.0
|
-3.6 units on a scale
Standard Deviation 1.9
|
PRIMARY outcome
Timeframe: 2 hoursCrossover exposure refers to the Session 2 virtual reality exposure for the control group and to the Session 2 imaginal exposure for the virtual reality group. The SUDs Rating Scale, or Subjective Units of Distress Scale (SUDs) is used to measure the intensity of distress or anxiety. The SUDs is a self-assessment tool rated on a scale from 0 to 10. Ten represents the highest level of distress and 0 represents no distress.
Outcome measures
| Measure |
VR System
n=24 Participants
Participants will then be assigned one week of daily exposure homework. Patients randomized to the intervention condition will take home the VR system for homework.
VR System: Use of virtual reality to deliver exposure therapy
|
Control Condition
n=17 Participants
Participants will then be assigned one week of daily exposure homework. Participants assigned to control will be instructed to complete imaginal exposures.
Control: Use of conventional delivery of exposure therapy
|
|---|---|---|
|
Maximum SUDS Rating During Crossover Exposure
|
2.1 units on a scale
Standard Deviation 2.3
|
2.5 units on a scale
Standard Deviation 1.8
|
SECONDARY outcome
Timeframe: 1 weekNumber of homework exposures completed.
Outcome measures
| Measure |
VR System
n=24 Participants
Participants will then be assigned one week of daily exposure homework. Patients randomized to the intervention condition will take home the VR system for homework.
VR System: Use of virtual reality to deliver exposure therapy
|
Control Condition
n=17 Participants
Participants will then be assigned one week of daily exposure homework. Participants assigned to control will be instructed to complete imaginal exposures.
Control: Use of conventional delivery of exposure therapy
|
|---|---|---|
|
Homework Engagement
|
5.4 homework exposures completed
Standard Deviation 1.5
|
5.9 homework exposures completed
Standard Deviation 1.3
|
Adverse Events
VR System
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Condition
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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