Schizophrenia Clinical Trial
— VR-SSOfficial title:
Physiology-based Virtual Reality Training for Social Skills in Schizophrenia
NCT number | NCT03128099 |
Other study ID # | MH106748 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 2016 |
Est. completion date | June 30, 2018 |
Verified date | March 2020 |
Source | Vanderbilt University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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, we must 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.
The investigators will test 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. VR technology offers a flexible
alternative to conventional therapies, with several advantages, including a simplified and
low-stress social interaction environment with targeted opportunities to simulate, exercise
and reinforce basic elements of social skills in a very wide range of realistic scenarios,
and to repeat exposure to naturalistic situations from multiple angles.
Status | Completed |
Enrollment | 47 |
Est. completion date | June 30, 2018 |
Est. primary completion date | June 30, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 21 Years to 60 Years |
Eligibility |
Inclusion and Exclusion Criteria: Individuals with Schizophrenia: - DSM-5 Axis 1 Diagnosis of schizophrenia - No DSM 5 Axis 1 diagnosis other than schizophrenia - 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 abuse/dependence during the past 1 year - No tardive dyskinesia - WASI 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. Inclusion and exclusion criteria for the healthy control group: - 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 abuse/dependence during the past 1 year - WAIS IQ > 90. |
Country | Name | City | State |
---|---|---|---|
United States | Vanderbilt University | Nashville | Tennessee |
Lead Sponsor | Collaborator |
---|---|
Vanderbilt University | University of California, San Diego |
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 | Social Attention: Social Engagement Latency (SEL) | Social Engagement Latency (SEL), defined as the time taken to select an avatar by fixating eye gaze at the chosen avatar's face to initiate a new social 'mission'. This is an ecologically valid index that corresponds to one's readiness to initiate a social interaction. To start a social 'mission', the participant must choose an avatar by fixating on a semi-transparent green patch that covers the avatar's face. When the participant fixates on the avatar's face, the green patch disappears to reveal the avatar's face, which starts the social mission game. The time takes to remove the green patch to reveal the avatar's face is the SEL, our primary social attention target and a useful index of pro-social attention engagement. |
5 weeks |
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