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

Schizophrenia Clinical Trial

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

Status Recruiting

Clinical Trial 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. '

The next phase, supported by a R33 grant will compare the VR social skills training with a control condition. This new protocol includes a control condition for the exposure to computerized training across the 10 sessions and incidental exposure to social interactions (i.e. interactions with experimenters twice a week for 5 weeks) by including a control condition, which involves computerized brain fitness training for 10 sessions.

Clinical Trial Description

The effectiveness of the social VR training (n=20) at an optimal dose will be compared with an active control condition (computerized cognitive training) (n=20) in improving social attention (Social Engagement Latency: SEL) and social brain network in a pilot randomized control trial (RCT).

Participants with schizophrenia will undergo a baseline assessment of cognition, social functioning, symptoms and social brain network functioning. These behavioral, clinical and functional neuroimaging (fMRI of social imitation task, and resting state connectivity analyses of the social brain network) methods will be used to assess changes.

Individuals with schizophrenia will be randomized to either the social skills training or the computerized cognitive training at baseline. They will then participate in 10 sessions of social skills VR training or computerized cognitive training (1 hour per session, twice a week for 5 weeks).

In addition, long-term social outcome will be assessed approximately 2 months after the end of training with 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). For the long-term outcome assessment, no neuroimaging or behavioral assessments will be conducted because the primary goal of the follow-up is to assess broad levels of social functioning in the real world and because there is not sufficient time within the R33 mechanism.

16 matched control participants will be recruited to obtain behavioral and neuroimaging 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 adaptive VR technology shows that it can improve social attention, which in turn improves 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. ;

Related Conditions & MeSH terms

• Mood Disorders
• Psychotic Disorders
• Schizo Affective Disorder
• Schizophrenia
• Social Skills

• NCT number: NCT04005794
• Study type: Interventional
• Source: Vanderbilt University
• Contact: Sohee Park, Ph.D.
• Phone: 6153220884
• Email: sohee.park@vanderbilt.edu
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2021
• Completion date: December 30, 2023