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

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Vanderbilt University

Status

Completed

Conditions

Schizophrenia
Schizo Affective Disorder
Social Skills

Treatments

Behavioral: Cognitive training (control game)
Behavioral: social VR (virtual reality) training

Study type

Interventional

Funder types

Other

Identifiers

NCT04005794
MH106748-R33

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

  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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Single Blind

50 participants in 2 patient groups

Schizophrenia group
Experimental group
Description:
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.
Treatment:
Behavioral: social VR (virtual reality) training
Behavioral: Cognitive training (control game)
Healthy Controls
No Intervention group
Description:
Healthy controls are recruited to yield comparison data. They do not undergo training.

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Michael Sangimino, B.A.; Sohee Park, Ph.D.

Data sourced from clinicaltrials.gov

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