Cognitive Rehabilitation With Immersive Virtual Reality (IVR) in Schizophrenia: a Pilot Randomize… (NCT07427485) | Clinical Trial Compass
CompletedNot Applicable
Cognitive Rehabilitation With Immersive Virtual Reality (IVR) in Schizophrenia: a Pilot Randomized Waiting List Controlled Feasibility Study
Italy40 participantsStarted 2025-03-11
Plain-language summary
Virtual reality-based rehabilitation has recently gained increasing attention in the field of cognitive rehabilitation, allowing patients to engage in simulated real-life scenarios within a safe and controlled setting. The feasibility and safety of immersive VR-based cognitive rehabilitation in individuals with schizophrenia is currently insufficiently explored. This study seeks to evaluate whether immersive immersive virtual reality-based rehabilitation can be safely and practically implemented in a community psychiatric setting. The study also aims to explore preliminary effects on negative symptoms, cognitive performance, and global functioning compared with treatment as usual in a waiting-list control group.
Who can participate
Age range
18 Years – 67 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Individuals with Schizophrenia/Schizoaffective Disorder (DSM-5-TR)
* Age 18-67 years
* Chronic phase of illness
* Able to provide a valid informed consent
Exclusion Criteria:
* Recent substance use (less than six months)
* Concomitant intellectual disability or neurological disorders (e.g., neurodegenerative disorders, Parkison's disease, brain cancer) that may impair the ability to undergo cognitive rehabilitation
* With a recent (less than six weeks from the enrolling date) symptom exacerbation, hospitalization or change in pharmacotherapy
* Acute phase of illness
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial used immersive virtual reality for cognitive rehabilitation in schizophrenia and schizoaffective disorder — how does VR-based cognitive rehab compare to the standard cognitive therapies you might already recommend for my situation?
2Since this was a pilot feasibility study, meaning it was designed to test whether the approach was practical rather than to definitively prove it works, what do the results actually tell us about whether it's safe and effective enough to consider?
3The trial measured symptoms using the PANSS scale — did the results show any meaningful change in positive symptoms like hallucinations or negative symptoms like motivation and social withdrawal, and would those findings be relevant to what I'm experiencing?
4This trial is now completed — is the full data published yet, and if so, would you be willing to review it with me to discuss whether this kind of intervention might be worth pursuing through another program or future study?
5Given that this was a waiting list controlled design rather than a comparison against an active treatment, how confident can we be that any improvements seen were actually due to the VR rehabilitation and not just the passage of time?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Positive and Negative Syndrome Scale (PANSS)
Timeframe: From enrollment to the end of treatment at 12 weeks
Trial details
NCT IDNCT07427485
SponsorAzienda Sanitaria Locale Napoli 3 Sud, UOCSM Torre del Greco