Clinical trial NCT03128099: Virtual Reality Training for Social Skills in Schizophrenia
Official title: Physiology-based Virtual Reality Training for Social Skills in Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Keywords: Social Skills
Social attention
Virtual reality
Eye tracking
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: University of California, San Diego
First posted: 2017-04-25
Enrollment: 47
Sex: ALL
Minimum age (years): 21
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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)
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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 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.

Primary outcomes:
measure: Social Attention: Social Engagement Latency (SEL)
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Sohee Park, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University
name: Nilanjan Sarkar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Adery LH, Ichinose M, Torregrossa LJ, Wade J, Nichols H, Bekele E, Bian D, Gizdic A, Granholm E, Sarkar N, Park S. The acceptability and feasibility of a novel virtual reality based social skills training game for schizophrenia: Preliminary findings. Psychiatry Res. 2018 Dec;270:496-502. doi: 10.1016/j.psychres.2018.10.014. Epub 2018 Oct 9.
citation: Torregrossa LJ, Bian D, Wade J, Adery LH, Ichinose M, Nichols H, Bekele E, Sarkar N, Park S. Decoupling of spontaneous facial mimicry from emotion recognition in schizophrenia. Psychiatry Res. 2019 May;275:169-176. doi: 10.1016/j.psychres.2019.03.035. Epub 2019 Mar 20.
citation: Wade J, Nichols HS, Ichinose M, Bian D, Bekele E, Snodgress M, Amat AZ, Granholm E, Park S, Sarkar N. Extraction of Emotional Information via Visual Scanning Patterns: A Feasibility Study of Participants with Schizophrenia and Neurotypical Individuals. ACM Trans Access Comput. 2018 Nov;11(4):23. doi: 10.1145/3282434.
citation: Roberts MT, Lloyd J, Valimaki M, Ho GW, Freemantle M, Bekefi AZ. Video games for people with schizophrenia. Cochrane Database Syst Rev. 2021 Feb 4;2(2):CD012844. doi: 10.1002/14651858.CD012844.pub2.