Virtual Reality Training for Social Skills in Schizophrenia (VR-SS)
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| ClinicalTrials.gov Identifier: NCT03128099 |
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Recruitment Status :
Completed
First Posted : April 25, 2017
Results First Posted : March 19, 2020
Last Update Posted : March 19, 2020
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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.
| Condition or disease | Intervention/treatment | Phase |
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| Schizophrenia | Behavioral: Virtual reality social skills training | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 47 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| 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) |
| Masking: | Double (Participant, 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. |
| Primary Purpose: | Basic Science |
| Official Title: | Physiology-based Virtual Reality Training for Social Skills in Schizophrenia |
| Actual Study Start Date : | June 2016 |
| Actual Primary Completion Date : | June 30, 2018 |
| Actual Study Completion Date : | June 30, 2018 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: 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.
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Behavioral: 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
Other Name: physiology based virtual reality social skills training |
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Experimental: High dose Low 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.
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Behavioral: 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
Other Name: physiology based virtual reality social skills training |
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No Intervention: Healthy Control Participants
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.
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- Social Attention: Social Engagement Latency (SEL) [ Time Frame: 5 weeks ]
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.
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| Ages Eligible for Study: | 21 Years to 60 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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 exclusion criteria for the healthy control group:
- No DSM-5 Axis 1 diagnosis of psychotic disorders in themselves or their families (e.g. schizophrenia, bipolar disorder).
- No antipsychotic medications
- 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
- WAIS IQ > 90.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03128099
| United States, Tennessee | |
| Vanderbilt University | |
| Nashville, Tennessee, United States, 37240 | |
| Principal Investigator: | Sohee Park, PhD | Vanderbilt University | |
| Principal Investigator: | Nilanjan Sarkar, PhD | Vanderbilt University |
Documents provided by Sohee Park, Vanderbilt University:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Sohee Park, Professor of Psychology, Vanderbilt University |
| ClinicalTrials.gov Identifier: | NCT03128099 |
| Other Study ID Numbers: |
MH106748 |
| First Posted: | April 25, 2017 Key Record Dates |
| Results First Posted: | March 19, 2020 |
| Last Update Posted: | March 19, 2020 |
| Last Verified: | March 2020 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Social Skills Social attention Virtual reality Eye tracking |
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Schizophrenia Schizophrenia Spectrum and Other Psychotic Disorders Mental Disorders |