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

NCT04005794 | Completed Results

• 1 other identifier: MH106748-R33
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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, 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.

Conditions

Schizophrenia; Schizo Affective Disorder; Social Skills

Keywords

schizophrenia; social skills training; social brain network; virtual reality; simulation; functional outcome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in Social Emotion Recognition: Bell-Lysaker Emotion Recognition Task Adult (BLERT-A)

  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)

  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)

  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.

  Baseline and after 8 sessions of training for social VR and after 8 sessions of active control game

Study Arms (2)

Schizophrenia group

EXPERIMENTAL

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; Behavioral: Cognitive training (control game)

Healthy Controls

NO INTERVENTION

Healthy controls are recruited to yield comparison data. They do not undergo training.

Interventions

social VR (virtual reality) training BEHAVIORAL

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.

Schizophrenia group

Cognitive training (control game) BEHAVIORAL

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.

Schizophrenia group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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.
• 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
• 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

Sponsors & Collaborators

• Vanderbilt University: lead

Study Sites (1)

Vanderbilt University

Nashville, Tennessee, 37240, United States

Location

Related Publications (3)

• 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.

  PMID: 30326433 RESULT

• 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.

  PMID: 30921747 RESULT

• 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.

  PMID: 30627303 RESULT

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders; Social Skills

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Sohee Park, Professor of Psychology and the principal investigator
• Organization: Vanderbilt University

sohee.park@vanderbilt.edu

615 322 3435

Study Officials

• Sohee Park, Ph.D.

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blind to the training condition. Schizophrenia participants know which games they are playing so although we do not tell them whether they are being trained for social skills or not, it is not possible to make sure that they are unaware of the types of games that they are asked to play
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychology

Model Details: Two conditions are compared in individuals with schizophrenia in a cross over design: social skills Virtual Reality (VR) training and active control condition of cognitive training game (non-social, cognitive video game). Participants are assigned at random to either start with social VR (Virtual Reality) skills training and cross over to the cognitive game at baseline, or start with the cognitive game and cross over to the social VR (Virtual Reality) training. They are assessed at baseline for symptoms, social function, emotion perception. They participate in the assigned condition until completion. They then get post-training assessments after which they switch over to the other condition. This cross-over design was implemented due to the closure of the laboratory during the pandemic. Healthy controls are run on the baseline tasks to provide the comparison data for the patient groups but the controls do not undergo VR training nor they yield any clinical symptoms data.

Study Record Dates

• First Submitted: June 26, 2019
• First Posted: July 2, 2019
• Study Start: October 15, 2021
• Primary Completion: May 30, 2024
• Study Completion: May 30, 2024
• Last Updated: March 10, 2025
• Results First Posted: March 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• 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.
• Access Criteria: Interested parties should contact the P.I. by email.

Locations

US (1)