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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: Completed NA study, sponsored by Vanderbilt University.
NCT04005794 is a NA study that has completed, run by Vanderbilt University. The registered enrollment target is 50 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Social engagement latency is defined as the time taken to select an avatar in the social skills training game. Social engagement latency is measured in milliseconds. We report the difference in SEL at post training from baseline for Sz group only
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 |
What the finished NCT04005794 record still lists
NCT04005794 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).
The record links to 0 conditions, and to 2 interventions - of which social VR (virtual reality) training is the first listed.
NCT04005794 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04005794's enrollment target sits among peer trials
50 1279th of 2000 higher than 622 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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