Schizophrenia Clinical Trial
Official title:
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. ' 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.
Status | Recruiting |
Enrollment | 56 |
Est. completion date | December 30, 2023 |
Est. primary completion date | December 30, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 1. Inclusion and Exclusion Criteria for Individuals with Schizophrenia: Inclusion criteria: - Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) Axis 1 Diagnosis of schizophrenia - Wechsler Abbreviated Scale of Intelligence (WASI) intelligence quotient (IQ) > 90 - 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: - 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: Inclusion Criteria: - WAIS IQ > 90. - No 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 |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University |
United States,
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. Psyc — View Citation
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. Epu — View Citation
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. AC — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Social Attention: Social Engagement Latency (SEL) | Social engagement latency is defined as the time taken to select an avatar to interact with. SE: is measured in milliseconds. This is the targeted mechanism identified in a previous R21 study. | Baseline and 5 weeks. | |
Primary | Change in Social Brain Network Activity | fMRI of social simulation task will identify the brain networks that are engaged during a social simulation task (see Thakkar, Peterman and Park. American Journal of Psychiatry. 2014) | Baseline and 5 weeks. | |
Secondary | Change in Social Emotion Recognition (BLERT) | BLERT (Bell-Lysaker Emotion Recognition Task; Bell et al, 1997). BLERT measures social cognition in people with schizophrenia and it has been reported to have the strongest psychometric properties for use in clinical trials. BLERT presents 21, 10-second video clips to measure the ability to identify seven emotional states: happiness, sadness, fear, disgust, surprise, anger, or no emotion. | Baseline and 5 weeks. | |
Secondary | 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 subscale has a single item global score for overall severity of each symptom domain. Each item is rated for severity from least (0) to most severe (5).
Andreasen NC: Scale for the Assessment of Negative Symptoms (SANS) . Iowa City, University of Iowa, 1983 |
Baseline and 5 weeks. In addition, it will also be used to assess long term outcome 2 months after the training has ended. | |
Secondary | 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 (rating=5) 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 5 weeks. In addition, it will also be used to assess long term outcome 2 months after the training has ended. | |
Secondary | Change in Social Outcome | Social Functioning Scale (SFS; Birchwood, 1990). This is a well validated measure used to assess social functioning. SFS consists of 76 items (7 subscales). Every subscale value is normalized to a Scaled Score (Mean = 100, SD = 15). The SFS full scale score is the mean of the 7 subscales scaled scores. The 7 subscales are: social engagement/withdrawal, interpersonal behavior, pro-social activities, recreation, independence-competence, independence-performance and employment. | Baseline and 5 weeks. In addition, it will also be used to assess long term outcome 2 months after the training has ended. |
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