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OpenTrials
Completed

NCT Number: NCT07427485

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

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.

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Key information

Conditions

SCHIZOPHRENIA 1 (Disorder) Mental Disorders Psychotic Disorders Schizoaffective Disorder Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Torre del Greco, Naples, 80059, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Positive and Negative Syndrome Scale (PANSS)

    Time frame: From enrollment to the end of treatment at 12 weeks

    Total score, positive and negative symptoms, general psychopathology. 30-item clinician-rated tool used to measure symptom severity in schizophrenia that ranges from 30pts. to 210pts (Total score). Higher values indicate higher severity. It includes three subscales: Positive, Negative (both range 7-49pts), and General Psychopathology (range 16-112pts.)

Secondary outcomes

  1. Digit Symbol Substitution Test (DSST)

    Time frame: From enrollment to the end of treatment at 12 weeks

    It measures processing speed. The score reflects the total number of correctly substituted symbols for corresponding single digit numbers during a 90-second timeframe. The score ranges from 0 upwards, with no theoretical limit. Higher score indicate better performance.

  2. Animal Naming Test (ANT)

    Time frame: From enrollment to the end of treatment at 12 weeks

    1-minute verbal fluency assessment requiring participants to name as many animals as possible in a 60 sec timeframe. Score can range from 0 to a theoretically unlimited maximum. Greater scores indicate better performance.

  3. Trail Making Test - A (TMT)

    Time frame: From enrollment to the end of treatment at 12 weeks

    Neuropsychological test to measure cognitive processing speed, visual scanning, and attention. It involves connecting 25 numbered circles in the least amount of time, evaluated in seconds. Score can range from 0 to a theoretically unlimited maximum. Lower time scores indicate better performance.

  4. Simple Reaction Time (SRT)

    Time frame: From enrollment to the end of treatment at 12 weeks

    It measures the psychomotor speed and is the minimal time required for an individual to detect a predictable sensory stimulus (an X on the screen) and initiate a motor response (i.e., pressing a button on the keyboard). Scores range from 0 to a theoretically unlimited maximum. It is evaluated in milliseconds (ms) and lower scores indicate a better performance.

  5. Choice Reaction Time (CRT)

    Time frame: From enrollment to the end of treatment at 12 weeks

    It is the interval between the presentation of one of several different stimuli and the initiation of a specific response (i.e., pressing the correct corresponding button on the keyboard). It measures cognitive processing speed, and score ranges from 0 to a theoretically unlimited maximum. Lower scores indicate better performance.

  6. Global Assessment of Functioning (GAF)

    Time frame: From enrollment to the end of treatment at 12 weeks

    It is a numeric scale (0-100) used to rate a person's overall psychological, social, and occupational functioning. Higher scores indicate a better performance.

Sponsors and collaborators

Lead sponsor

Azienda Sanitaria Locale Napoli 3 Sud, UOCSM Torre del Greco

Other

Registry information

Acronym: IVR SCZ

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 23, 2026
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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