Schizophrenia Clinical Trial
Official title:
Physiology-based Virtual Reality Training for Social Skills in Schizophrenia
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.
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