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N/A N=50 Randomized Single-blind Basic Science

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

Schizophrenia · Schizo Affective Disorder · Social Skills

Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Change in Social Attention: Social Engagement Latency (SEL) — -195 milliseconds — p=0.004

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
social VR (virtual reality) training (Behavioral); Cognitive training (control game) (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Vanderbilt University
Primary completion
May 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Change in Social Attention: Social Engagement Latency (SEL)
-195 0.004 sig
SECONDARY
Change in Social Emotion Recognition: Bell-Lysaker Emotion Recognition Task Adult (BLERT-A)
12.68; 12.68; 18; 13.00; 13.16 0.213
SECONDARY
Change in Scale for the Assessment of Negative Symptoms (SANS)
44.63636364; 44.63636364; 34.79; 43.67 0.01 sig
SECONDARY
Change in Scale for the Assessment of Positive Symptoms (SAPS)
37.86363636; 37.86363636; 28.32; 31.28 0.004 sig
SECONDARY
Change in Social Outcome: Social Functioning Scale.
96.63636364; 96.63636364; 107.25; 98.74; 97.56 >0.05

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.

Eligibility Criteria

  • 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
  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04005794). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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