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Cognitive Rehabilitation With Immersive Virtual Reality (IVR) in Schizophrenia: a Pilot Randomized Waiting List Controlled Feasibility Study

NCT07427485 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-06-15

No results posted yet for this study

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.

Conditions

  • SCHIZOPHRENIA 1 (Disorder)
  • Schizoaffective Disorder

Interventions

DEVICE

CEREBRUM VR

The Oculus Quest 3 Virtual Reality Headset, two joysticks, and the CEREBRUM - Virtual Cognitive Rehabilitation add-on tool are employed for the immersive virtual reality cognitive rehabilitation. The headset allows for an IVR 360° experience with spatial tracking and ability to free-roam in the virtual reality space. The aforementioned tool simulates real-life everyday scenarios, engaging different domains including memory and learning, cognitive estimates, metacognition and social interaction, attention and working memory, and planning. The Cerebrum protocol also allows for a personalized and adaptive difficulty based on each individual's abilities. Each session consists in a welcoming and 4-5 exercises from different domains. Each session is supervised by a Psychiatric Rehabilitation Professional.

OTHER

Waiting List

Participants will to not receive the IVR-based rehabilitation, but rather will be offered after the study ends. They will continue with their therapy as usual.

Sponsors & Collaborators

  • Azienda Sanitaria Locale Napoli 3 Sud, UOCSM Torre del Greco

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
67 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-11
Primary Completion
2026-03-11
Completion
2026-03-11

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07427485 on ClinicalTrials.gov