Trial Outcomes & Findings for Virtual Reality Training for Social Skills in Schizophrenia (NCT NCT03128099)
NCT ID: NCT03128099
Last Updated: 2020-03-19
Results Overview
Social Engagement Latency (SEL), defined as the time taken to select an avatar by fixating eye gaze at the chosen avatar's face to initiate a new social 'mission'. This is an ecologically valid index that corresponds to one's readiness to initiate a social interaction. To start a social 'mission', the participant must choose an avatar by fixating on a semi-transparent green patch that covers the avatar's face. When the participant fixates on the avatar's face, the green patch disappears to reveal the avatar's face, which starts the social mission game. The time takes to remove the green patch to reveal the avatar's face is the SEL, our primary social attention target and a useful index of pro-social attention engagement.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
47 participants
Primary outcome timeframe
5 weeks
Results posted on
2020-03-19
Participant Flow
Participant milestones
| Measure |
Low Dose VR Social Skills Training
In the low dose condition, participants play the video game for one hour per session. This is a behavioral intervention study. The intervention is playing the social skills virtual reality game to exercise social skills with avatar characters.
Virtual reality social skills training: Participants play a virtual reality video game involving social interactions with various characters ( avatars) at a bus stop, a cafeteria and a grocery store. The games become progressively more complex as the participant improves task performance. Eye tracking patterns are recorded throughout the game to observe the patterns of social attention. Social attention was indexed by a measure called Social Engagement latency (SEL).
|
High Dose VR Social Skills Training
In the high dose condition, participants play the same video game twice per session (it takes them two hours). This is a behavioral intervention study. The intervention is playing the social skills virtual reality game to exercise social skills with avatar characters.
Virtual reality social skills training: Participants play a virtual reality video game involving social interactions with various characters ( avatars) at a bus stop, a cafeteria and a grocery store. The games become progressively more complex as the participant improves task performance. Eye tracking patterns are recorded throughout the game to observe the patterns of social attention. Social attention was indexed by a measure called Social Engagement latency (SEL).
|
Healthy Control Participants
Control participants were recruited to obtain normative data
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
4
|
22
|
|
Overall Study
Hour 1 (Low Dose) Started
|
21
|
4
|
22
|
|
Overall Study
Hour 1 (Low Dose) Completed
|
19
|
4
|
21
|
|
Overall Study
Hour 2 (High Dose)Started
|
0
|
4
|
0
|
|
Overall Study
Hour 2 (High Dose) Completed
|
0
|
0
|
0
|
|
Overall Study
COMPLETED
|
19
|
0
|
21
|
|
Overall Study
NOT COMPLETED
|
2
|
4
|
1
|
Reasons for withdrawal
| Measure |
Low Dose VR Social Skills Training
In the low dose condition, participants play the video game for one hour per session. This is a behavioral intervention study. The intervention is playing the social skills virtual reality game to exercise social skills with avatar characters.
Virtual reality social skills training: Participants play a virtual reality video game involving social interactions with various characters ( avatars) at a bus stop, a cafeteria and a grocery store. The games become progressively more complex as the participant improves task performance. Eye tracking patterns are recorded throughout the game to observe the patterns of social attention. Social attention was indexed by a measure called Social Engagement latency (SEL).
|
High Dose VR Social Skills Training
In the high dose condition, participants play the same video game twice per session (it takes them two hours). This is a behavioral intervention study. The intervention is playing the social skills virtual reality game to exercise social skills with avatar characters.
Virtual reality social skills training: Participants play a virtual reality video game involving social interactions with various characters ( avatars) at a bus stop, a cafeteria and a grocery store. The games become progressively more complex as the participant improves task performance. Eye tracking patterns are recorded throughout the game to observe the patterns of social attention. Social attention was indexed by a measure called Social Engagement latency (SEL).
|
Healthy Control Participants
Control participants were recruited to obtain normative data
|
|---|---|---|---|
|
Overall Study
High dose task was too long
|
0
|
4
|
0
|
|
Overall Study
Participant got a full time job.
|
1
|
0
|
0
|
|
Overall Study
Became homeless and lost contact
|
1
|
0
|
0
|
|
Overall Study
Did not complete all the assessments
|
0
|
0
|
1
|
Baseline Characteristics
No participants completed the High dose VR social skills training. The control group did not receive any VR training
Baseline characteristics by cohort
| Measure |
Low Dose VR Social Skills Training
n=21 Participants
In the low dose condition, participants play the video game for one hour per session. This is a behavioral intervention study. The intervention is playing the social skills virtual reality game to exercise social skills with avatar characters.
Virtual reality social skills training: Participants play a virtual reality video game involving social interactions with various characters ( avatars) at a bus stop, a cafeteria and a grocery store. The games become progressively more complex as the participant improves task performance. Eye tracking patterns are recorded throughout the game to observe the patterns of social attention
|
High Dose VR Social Skills Training
n=4 Participants
In the high dose condition, participants play the same video game twice per session (it takes them two hours). This is a behavioral intervention study. The intervention is playing the social skills virtual reality game to exercise social skills with avatar characters.
Virtual reality social skills training: Participants play a virtual reality video game involving social interactions with various characters ( avatars) at a bus stop, a cafeteria and a grocery store. The games become progressively more complex as the participant improves task performance. Eye tracking patterns are recorded throughout the game to observe the patterns of social attention
|
Healthy Control Participants
n=22 Participants
Control participants were recruited to provide normative data
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
48.78 years
STANDARD_DEVIATION 7.42 • n=21 Participants
|
47.52 years
STANDARD_DEVIATION 10.08 • n=4 Participants
|
45.65 years
STANDARD_DEVIATION 8.17 • n=22 Participants
|
47.2 years
STANDARD_DEVIATION 7.8 • n=47 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=21 Participants
|
0 Participants
n=4 Participants
|
12 Participants
n=22 Participants
|
22 Participants
n=47 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=21 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=22 Participants
|
25 Participants
n=47 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=21 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=22 Participants
|
1 Participants
n=47 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=21 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=22 Participants
|
3 Participants
n=47 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=21 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=47 Participants
|
|
Race (NIH/OMB)
Black or African American
|
13 Participants
n=21 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=22 Participants
|
22 Participants
n=47 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=21 Participants
|
0 Participants
n=4 Participants
|
14 Participants
n=22 Participants
|
20 Participants
n=47 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=21 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=22 Participants
|
0 Participants
n=47 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=21 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=22 Participants
|
1 Participants
n=47 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=21 Participants
|
4 participants
n=4 Participants
|
22 participants
n=22 Participants
|
47 participants
n=47 Participants
|
|
Baseline Social Attention
|
32824 milliseconds
STANDARD_DEVIATION 11932 • n=21 Participants • No participants completed the High dose VR social skills training. The control group did not receive any VR training
|
—
|
—
|
32824 milliseconds
STANDARD_DEVIATION 11932 • n=21 Participants • No participants completed the High dose VR social skills training. The control group did not receive any VR training
|
PRIMARY outcome
Timeframe: 5 weeksPopulation: NB: We did not run high dose condition due to the feasibility problem. Control participants do not undergo training. Therefore only the results of the low dose condition are reported
Social Engagement Latency (SEL), defined as the time taken to select an avatar by fixating eye gaze at the chosen avatar's face to initiate a new social 'mission'. This is an ecologically valid index that corresponds to one's readiness to initiate a social interaction. To start a social 'mission', the participant must choose an avatar by fixating on a semi-transparent green patch that covers the avatar's face. When the participant fixates on the avatar's face, the green patch disappears to reveal the avatar's face, which starts the social mission game. The time takes to remove the green patch to reveal the avatar's face is the SEL, our primary social attention target and a useful index of pro-social attention engagement.
Outcome measures
| Measure |
Low Dose VR Social Skills Training
n=18 Participants
In the low dose condition, participants play the video game for one hour per session. This is a behavioral intervention study. The intervention is playing the social skills virtual reality game to exercise social skills with avatar characters.
Virtual reality social skills training: Participants play a virtual reality video game involving social interactions with various characters ( avatars) at a bus stop, a cafeteria and a grocery store. The games become progressively more complex as the participant improves task performance. Eye tracking patterns are recorded throughout the game to observe the patterns of social attention
|
|---|---|
|
Social Attention: Social Engagement Latency (SEL)
|
21618 msec
Standard Deviation 4134
|
Adverse Events
Low Dose VR Social Skills Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High Dose VR Social Skills Training
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Controls
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