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Virtual Reality Training for Social Skills in Schizophrenia

Physiology-based Virtual Reality Training for Social Skills in Schizophrenia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03128099
Acronym
VR-SS
Enrollment
47
Registered
2017-04-25
Start date
2016-06-30
Completion date
2018-06-30
Last updated
2020-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Social Skills, Social attention, Virtual reality, Eye tracking

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALVirtual 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

Sponsors

University of California, San Diego
CollaboratorOTHER
Vanderbilt University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Participants are assigned to low or high dose randomly. They do not know which condition they are in. The research staff who assess symptoms before and after training do not know which condition the participant is assigned to.

Intervention model description

Half the participants play the virtual reality video game for one hour per session (low dose). The other half play the virtual reality video game for 2 hours per session (high dose). Both groups visit the lab 10 times ( twice a week for 5 weeks)

Eligibility

Sex/Gender
ALL
Age
21 Years to 60 Years
Healthy volunteers
Yes

Inclusion criteria

Inclusion and

Exclusion criteria

Individuals with Schizophrenia: * DSM-5 Axis 1 Diagnosis of schizophrenia * No DSM 5 Axis 1 diagnosis other than schizophrenia * No diagnosed organic brain disease, brain lesions, history of head traumas, neurological disorders or other conditions that involve the degeneration of the central nervous system (e.g. multiple sclerosis) * No substance/alcohol abuse/dependence during the past 1 year * No tardive dyskinesia * WASI IQ\> 90 * Currently taking antipsychotic medication * No change in current psychotropic medications or housing within the past 30 days. Those patients whose medication or housing situation has changed within a month, we will wait list them until their situation stabilizes. Inclusion and

Design outcomes

Primary

MeasureTime frameDescription
Social Attention: Social Engagement Latency (SEL)5 weeksSocial 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
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
21
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
4
Healthy Control Participants
Control participants were recruited to provide normative data
22
Total47

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyBecame homeless and lost contact100
Overall StudyDid not complete all the assessments001
Overall StudyHigh dose task was too long040
Overall StudyParticipant got a full time job.100

Baseline characteristics

CharacteristicTotalLow Dose VR Social Skills TrainingHigh Dose VR Social Skills TrainingHealthy Control Participants
Age, Continuous47.2 years
STANDARD_DEVIATION 7.8
48.78 years
STANDARD_DEVIATION 7.42
47.52 years
STANDARD_DEVIATION 10.08
45.65 years
STANDARD_DEVIATION 8.17
Baseline Social Attention32824 milliseconds
STANDARD_DEVIATION 11932
32824 milliseconds
STANDARD_DEVIATION 11932
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants0 Participants0 Participants1 Participants
Race (NIH/OMB)
Asian
3 Participants1 Participants0 Participants2 Participants
Race (NIH/OMB)
Black or African American
22 Participants13 Participants4 Participants5 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants1 Participants0 Participants0 Participants
Race (NIH/OMB)
White
20 Participants6 Participants0 Participants14 Participants
Region of Enrollment
United States
47 participants21 participants4 participants22 participants
Sex: Female, Male
Female
22 Participants10 Participants0 Participants12 Participants
Sex: Female, Male
Male
25 Participants11 Participants4 Participants10 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
deaths
Total, all-cause mortality
0 / 210 / 40 / 22
other
Total, other adverse events
0 / 210 / 40 / 22
serious
Total, serious adverse events
0 / 210 / 40 / 22

Outcome results

Primary

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

Population: 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

ArmMeasureValue (MEAN)Dispersion
Low Dose VR Social Skills TrainingSocial Attention: Social Engagement Latency (SEL)21618 msecStandard Deviation 4134

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026