An interventional study of Virtual reality social skills training in Schizophrenia, sponsored by Vanderbilt University. Completed at 1 site in United States. Open to participants aged 21 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-03-19.
Sponsored by Vanderbilt University · Not applicable, Interventional, and Basic science
Social impairments are core features of schizophrenia that lead to poor outcome. Social skills and competence improve quality of life and protect against stress-related exacerbation of symptoms, while supporting resilience, interpersonal interactions, and social affiliation. To improve outcome, we must remediate social deficits. Existing psychosocial interventions are moderately effective but the effort-intensive nature (high burden), low adherence, and weak transfer of skills to everyday life present significant hurdles toward recovery. Thus, there is a dire need to develop effective, engaging and low-burden social interventions for people with schizophrenia that will result in better compliance rates and functional outcome.
The investigators will test the effectiveness of a novel adaptive virtual reality (VR) intervention in improving targeted social cognitive function (social attention, as indexed by eye scanning patterns) in individuals with schizophrenia. VR technology offers a flexible alternative to conventional therapies, with several advantages, including a simplified and low-stress social interaction environment with targeted opportunities to simulate, exercise and reinforce basic elements of social skills in a very wide range of realistic scenarios, and to repeat exposure to naturalistic situations from multiple angles.
Social impairments present a major barrier toward good outcome in schizophrenia (SZ). Social skills and social competence protect against stress-related exacerbation of symptoms while supporting interpersonal interactions and social affiliation that help enhance the quality of life. Improving social functions could lead to better outcome and reduce healthcare costs and societal burden. Pharmacotherapy has shown to be inadequate in improving social impairments in schizophrenia, and although existing psychosocial interventions can be moderately effective, the time- and effort-intensive nature (high-burden), low adherence, and weak transfer of skills to real life present significant hurdles. Thus, there is a strong need to develop effective and low-burden social interventions that can be personalized to optimize learning and increase adherence.
Virtual reality (VR) technology offers a very promising alternative to conventional interventions, with several advantages. Controllable complexity of the VR world provides a simplified and low-stress social interaction environment with targeted opportunities to simulate, exercise and reinforce basic elements of social skills and to repeat exposure to naturalistic situations from multiple angles. Simulation of a wide variety of social situations that allows for targeted practice is crucial for learning and transfer of skills. In our proposed VR system, the capacity for personalized social skills training is achieved by automatic and adaptive feedback, based on the affective and attentional states of the participant in real-time, using closed-loop, emotion-sensing VR technology that integrates physiological signals, eye-tracking data and performance data from the participants to rapidly adjust the task parameters. This approach enables realistic, and adaptive interactions in VR games to provide scaffolded social skills exercises in an engaging and enjoyable manner.
The major aim of this proposal is to implement a personalized VR-based social skills training program with high efficacy for individuals with SZ by capitalizing on innovations in adaptive, emotion-sensing technology, designed to increase engagement and learning. This work will be conducted in two phases. The R21 phase will focus on implementing an adaptive social intervention VR game, optimizing the dose and measuring targeted social cognitive outcome. Upon meeting the milestones of the R21 (see 'Approach'), the R33 project will evaluate the feasibility of recruitment, and retention of SZ participants in a pilot randomized controlled trial (RCT) of VR training compared with an active control condition and assess long-term outcome.
The long-term goal of this proposal is to develop and implement a personalized social intervention method for individuals with schizophrenia that is efficacious, low-burden, enjoyable, and with generalizable and enduring benefits. Within the R21 phase, a physiology-based, closed-loop, adaptive VR task will be developed to determine the optimal dose for improving targeted social functions in individuals with SZ. If these goals are met for the R21 phase, a pilot RCT will be conducted in R33 to compare the social, cognitive, neural effects of adaptive social VR versus an active control condition. Furthermore, the physiological and eye tracking data and the outcome data from both R21 and R33 phases will be used to refine and improve this VR protocol and technology. It is hoped that the results of this study will lead to a large scale RCT in the future, and the implementation of a portable, low-cost and widely available intervention that can be personalized for optimal learning. In short, the investigators will implement an efficacious, engaging, low-burden, VR intervention to ameliorate social impairments of SZ and improve functional outcome.
3,539 studies on the registry are indexed under Schizophrenia; 473 are open to participants now.
This study's enrollment of 47 is below the median of 70 across 2,924 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →Vanderbilt University is the lead sponsor of 520 studies on the registry; 18 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 5 (63%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion and Exclusion Criteria:
Individuals with Schizophrenia:
Inclusion and exclusion criteria for the healthy control group:
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.
Behavioral: Virtual reality 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.
Behavioral: Virtual reality social skills training
23 healthy control participants were recruited and consented to yield baseline comparison data. These participants did not undergo VR training. Only baseline comparison data were collected.
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
Also known as: physiology based virtual reality social skills training
Social Attention: Social Engagement Latency (SEL)
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.
Time frame: 5 weeks
| Milestone | Low Dose VR Social Skills Training | High Dose VR Social Skills Training | Healthy Control Participants |
|---|---|---|---|
| Started | 21 | 4 | 22 |
| Hour 1 (low dose) started | 21 | 4 | 22 |
| Hour 1 (low dose) completed | 19 | 4 | 21 |
| Hour 2 (high dose)started | 0 | 4 | 0 |
| Hour 2 (high dose) completed | 0 | 0 | 0 |
| Completed | 19 | 0 | 21 |
| Not completed | 2 | 4 | 1 |
| Withdrew: High dose task was too long | 0 | 4 | 0 |
| Withdrew: Participant got a full time job. | 1 | 0 | 0 |
| Withdrew: Became homeless and lost contact | 1 | 0 | 0 |
| Withdrew: Did not complete all the assessments | 0 | 0 | 1 |
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.
| msec | Low Dose VR Social Skills Training |
|---|---|
| Social Attention: Social Engagement Latency (SEL) | 21618 ± 4134 |
Collected over The training took 5 weeks but the pre-training baseline data collection and post-training assessment were conducted before and after these 5-week training periods. Therefore potential adverse events were monitored for each participant for between 7 weeks and 10 weeks. There were no adverse events.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Low Dose VR Social Skills Training | 0/21 (0%) | 0/21 (0%) | 0/21 (0%) |
| High Dose VR Social Skills Training | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Healthy Controls | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Age, Continuous(years) | Low Dose VR Social Skills Training | High Dose VR Social Skills Training | Healthy Control Participants | Total |
|---|---|---|---|---|
| Mean | 48.78 ± 7.42 | 47.52 ± 10.08 | 45.65 ± 8.17 | 47.2 ± 7.8 |
| Sex: Female, Male(Participants) | Low Dose VR Social Skills Training | High Dose VR Social Skills Training | Healthy Control Participants | Total |
|---|---|---|---|---|
| Female | 10 | 0 | 12 | 22 |
| Male | 11 | 4 | 10 | 25 |
| Race (NIH/OMB)(Participants) | Low Dose VR Social Skills Training | High Dose VR Social Skills Training | Healthy Control Participants | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 1 | 1 |
| Asian | 1 | 0 | 2 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 13 | 4 | 5 | 22 |
| White | 6 | 0 | 14 | 20 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 0 | 1 |
| Region of Enrollment(participants) | Low Dose VR Social Skills Training | High Dose VR Social Skills Training | Healthy Control Participants | Total |
|---|---|---|---|---|
| United States | 21 | 4 | 22 | 47 |
| Baseline Social Attention(milliseconds) | Low Dose VR Social Skills Training | High Dose VR Social Skills Training | Healthy Control Participants | Total |
|---|---|---|---|---|
| Mean | 32824 ± 11932 | — | — | 32824 ± 11932 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Jun 2016 to primary completion in Jun 2018, 24 months.
Results were first posted in Mar 2020, 1 year 8 months after primary completion.
Of 755 non-industry interventional studies with no phase under Schizophrenia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 56. This study's 24 months is below that.
Counting every sponsor, half of 768 studies reached it within 32 months; a quarter within 16 and three quarters within 55.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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