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NCT04005794 · ClinicalTrials.gov registry record · NA
Virtual Reality Training for Social Skills in Schizophrenia - Comparison With Cognitive Training
A NA study, sponsored by Vanderbilt University.
- Completed
- Registry status
- NA
- Development phase
- 50
- Enrollment target
NCT04005794 is a NA study that has completed, run by Vanderbilt University. The registered enrollment target is 50 participants.
The verdict
NCT04005794, a NA study, has completed, sponsored by Vanderbilt University.
- COMPLETED
- Registry status
- NA
- Development phase
- 50 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL social VR (virtual reality) training
- BEHAVIORAL Cognitive training (control game)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2021-10-15 |
| Est. Completion | 2024-05-30 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04005794
The ClinicalTrials.gov registry entry for NCT04005794 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 50 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Vanderbilt University, which has 430 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which social VR (virtual reality) training is the first listed.
NCT04005794 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04005794 about?
NCT04005794 is a clinical study titled "Virtual Reality Training for Social Skills in Schizophrenia - Comparison With Cognitive Training". 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 i...
What is the current status of trial NCT04005794?
This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2021-10-15. Estimated completion is 2024-05-30.
What interventions are being tested in trial NCT04005794?
The interventions under investigation include: social VR (virtual reality) training (BEHAVIORAL), Cognitive training (control game) (BEHAVIORAL).
Who is sponsoring clinical trial NCT04005794?
This trial is sponsored by Vanderbilt University, which has 430 total clinical trials registered on ClinicalTrials.gov.
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