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

NCT07427485 | Active Not Recruiting

• 1 other identifier: 29475 - 02/03/2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

rehabilitation; cognitive remediation; community mental health

Outcome Measures

Primary Outcomes (1)

• Positive and Negative Syndrome Scale (PANSS)

  Total score, positive and negative symptoms, general psychopathology

  From enrollment to the end of treatment at 12 weeks

Secondary Outcomes (6)

• Digital Symbol Substitution Test (DSST)

  From enrollment to the end of treatment at 12 weeks

• Animal Naming Test (ANT)

  From enrollment to the end of treatment at 12 weeks

• Trial Making Test - A (TMT)

  From enrollment to the end of treatment at 12 weeks

• Simple Reaction Time (SRT)

  From enrollment to the end of treatment at 12 weeks

• Choice Reaction Time (CRT)

  From enrollment to the end of treatment at 12 weeks

Study Arms (2)

Immersive Virtual Reality-Based Cognitive Rehabilitation

EXPERIMENTAL

patients will undergo IVR-based cognitive rehabilitation sessions (about 45minutes) for 12 weeks as an adjunct to the Therapy as Usual (TAU)

Device: CEREBRUM VR

Waiting List

OTHER

The patients randomized to the waiting list arm will not undergo IVR rehabilitation, but rather continue with TAU

Other: Waiting List

Interventions

CEREBRUM VR DEVICE

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.

Immersive Virtual Reality-Based Cognitive Rehabilitation

Waiting List OTHER

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.

Waiting List

Eligibility Criteria

• Age: 18 Years - 67 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals with Schizophrenia/Schizoaffective Disorder (DSM-5-TR)
• Age 18-67 years
• Chronic phase of illness
• Able to provide a valid informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Azienda Sanitaria Locale Napoli 3 Sud Unità Operativa Complessa Salute Mentale Torre del Greco/Ercolano

Torre del Greco, Naples, 80059, Italy

Location

Related Publications (2)

• Angelov V, Petkov E, Shipkovenski G, Kalushkov T, editors. Modern virtual reality headsets. 2020 International congress on human-computer interaction, optimization and robotic applications (HORA); 2020: IEEE.

  BACKGROUND

• Primavera D, Migliaccio GM, Garau V, Orru G, Scano A, Perra A, Pinna S, Tusconi M, Carta MG, Sancassiani F. Improving Quality of Life in Bipolar Disorders with an Immersive Virtual Reality Remediation Training Randomized Controlled Trial (RCT). J Clin Med. 2024 Jul 2;13(13):3886. doi: 10.3390/jcm13133886.

  PMID: 38999451 BACKGROUND

MeSH Terms

Conditions

Psychotic Disorders

Interventions

Waiting Lists

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2026
• First Posted: February 23, 2026
• Study Start: March 11, 2025
• Primary Completion: February 1, 2026
• Study Completion: March 1, 2026
• Last Updated: February 23, 2026

Record last verified: 2026-02

Locations

IT (1)