Virtual Reality Training for Social Skills in Schizophrenia - Comparison With Cognitive Training

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, it is necessary to 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.

In a previous pilot study, the investigators tested 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. 10 sessions of 1-hour VR intervention were sufficient to engage the target mechanism of social attention and improve negative symptoms. Acceptability and compliance were very high among the participants. In fact, improvements were seen at about 4-5 sessions. Therefore, we used 8 sessions for the R33 phase.

The next phase, supported by a R33 grant compares the VR social skills training with a control condition. This new protocol includes a control condition for the exposure to computerized training across the 8 sessions and incidental exposure to social interactions (i.e. interactions with experimenters twice a week for 4-5 weeks). The control condition consists of commercially available cognitive video games played on the same computer for the same duration as the social VR training condition. This control condition is called Cognitive training game condition.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Social Skills; Schizo Affective Disorder
• Intervention / Treatment: Behavioral: social VR (virtual reality) training; Behavioral: Cognitive training (control game)

Detailed Description

The effectiveness of the social skills VR training at an optimal dose will be compared with an active control condition (computerized cognitive training game) in improving social attention (Social Engagement Latency: SEL), symptoms and social cogitive functioning in a pilot randomized cross-over trial.

Participants with schizophrenia will undergo a baseline assessment of social cognitive functioning, and clinical symptoms. Potential changes after Social skills VR training compared with cognitive game training will be examined.

Individuals with schizophrenia will be randomized to either the social skills VR training or the cognitive training at baseline. They will then participate in 8 sessions of social skills VR training or cognitive training (1 hour per session, twice a week for 4-5 weeks). After completion of the 8 sessions per training condition, they will cross over and participate in the other condition.

Social engagement latency (SEL) will be used as a measure of social attention which is the primary target. The Social Functional Scale (Birchwood, 1991), the the Scale for the Assessment of Negative Symptoms (SANS) and the Scale for the Assessment of Positive Symptoms (SAPS) will be used to assess social functioning and symptoms. Emotion perception will be assesed by the Bell-Lysaker Emotion Recognition Task (BLERT-A).

Matched healthy control participants will be recruited to obtain comparison data for optimal performance levels but these healthy control participants will not undergo social skills training.

Lastly, at the end of the R33 project, if this VR social skills VR training shows that it can improve social attention, which may improve social outcome in schizophrenia, it will be possible to refine the protocol to make the method more accessible, less burdensome and widely available in the future by moving towards a mobile application.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37240
      • Vanderbilt University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

1. Inclusion and Exclusion Criteria for Individuals with Schizophrenia:

   Inclusion criteria for schizophrenia group:

   • Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) Axis 1 Diagnosis of schizophrenia
   • Wechsler Abbreviated Scale of Intelligence (WASI) intelligence quotient (IQ) > 85
   • 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.

   Exclusion criteria for schizophrenia group:

   • Diagnostic and Statistical Manual of Mental Disorders-5 (DSM 5) Axis 1 diagnosis other than schizophrenia
   • 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)
   • Substance/alcohol dependence during the past 1 year
   • Tardive dyskinesia

2. Inclusion and Exclusion Criteria for Healthy Control Participants:

   • Wechsler Abbreviated Scale of Intelligence (WAIS) IQ > 85
   • No Diagnostic and Statistical Manual of Mental Disorders-5 (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 dependence during the past 1 year

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Healthy Controls; Healthy controls are recruited to yield comparison data. They do not undergo training.
Experimental: Schizophrenia group; Participants undergo both social VR (virtual reality) training and a control game sequentially. They are randomly assigned at baseline to one training condition. After completing 8 sessions, they cross over to the other condition. There are two training conditions: social VR and cognitive training game.	Behavioral: social VR (virtual reality) training; Social skills game that we developed in the R21 phase will be used across 8 sessions of training in the lab. Each session is about 1 hour long. Participants come to the lab twice a week for 4-5 weeks.; Behavioral: Cognitive training (control game); Commercially available cognitive training program will be used to control for the time spent in the lab and associated social interactions as well as the total exposure to computerized games.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Social Attention: Social Engagement Latency (SEL)	Social engagement latency is defined as the time taken to select an avatar in the social skills training game. Social engagement latency is measured in milliseconds. We report the difference in SEL at post training from baseline for Sz group only	Baseline and social VR post-training (after 8 sessions)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Social Emotion Recognition: Bell-Lysaker Emotion Recognition Task Adult (BLERT-A)	Change in social cognition using the Bell-Lysaker Emotion Recognition Task Adult (BLERT-A). There are 21 videos shown to participants and are scored as either correct (1) or incorrect (0). A total score is provided and can range from 0 to 21, with higher scores indicating a higher social cognition ability, a better outcome.	Baseline and after 8 sessions of social VR training and after 8 sessions of cognitive training game
Change in Scale for the Assessment of Negative Symptoms (SANS)	SANS is a 25-item clinical symptom rating scale. It consists subscales of alogia, affective blunting, avolition-apathy, anhedonia-asociality, and attentional impairment. (Andreasen, 1983). Each item is scored on likert scale of 0 (none) to 5 (severe - worse outcome). Total score is summed (range 0-125) with higher scores being a worse outcome Andreasen NC: Scale for the Assessment of Negative Symptoms (SANS) . Iowa City, University of Iowa, 1983	Baseline and after 8 sessions of training for social VR and after 8 sessions of active control game for the schizophrenia group only. CO do not undergo clinical symptoms interview.
Change in Scale for the Assessment of Positive Symptoms (SAPS)	SAPS has 34-items that evaluate hallucinations, delusions, formal thought disorder and bizarre behavior (Andreasen, 1984). Each subscale has a single global score item to rate the overall severity of each symptom domain. Each item is rated for severity from least (0) to most severe (5). Total scores are summed and range from 0-170 with higher scores indicating a worse outcome. Andreasen NC: Scale for the Assessment of Positive Symptoms (SAPS) . Iowa City, University of Iowa, 1984. (NC Andreasen - The British Journal of Psychiatry, 1989)	Baseline and after 8 sessions of training for social VR and after 8 sessions of active control game
Change in Social Outcome: Social Functioning Scale.	Social Functioning Scale (SFS; Birchwood, 1990). SFS consists of 79 items (7 subscales). We use the full scale score. Minimum score is 0 (worst social functioning) and maximum score is 135 (best)	Baseline and after 8 sessions of training for social VR and after 8 sessions of active control game

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Investigators: Principal Investigator: Sohee Park, Ph.D., Vanderbilt University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2021
• Primary Completion (Actual): May 30, 2024
• Study Completion (Actual): May 30, 2024

Study Registration Dates

• First Submitted: June 26, 2019
• First Submitted That Met QC Criteria: July 1, 2019
• First Posted (Actual): July 2, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 18, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: schizophrenia; simulation; virtual reality; functional outcome; social skills training; social brain network
• Additional Relevant MeSH Terms: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia; Psychotic Disorders; Mood Disorders
• Other Study ID Numbers: MH106748-R33

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: We are comparing a social skills game in virtual reality with a cognitive training software. After the study is completed, we will make the protocol and the methods available to all those who request this information.
• IPD Sharing Time Frame: After the study has ended and we have been able to publish the outcome of the study. This is expected to be within 2 years of the completion of the study.
• IPD Sharing Access Criteria: Interested parties should contact the P.I. by email.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No