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

A

Azienda Sanitaria Locale Napoli 3 Sud, UOCSM Torre del Greco

Status

Active, not recruiting

Conditions

Schizoaffective Disorder
SCHIZOPHRENIA 1 (Disorder)

Treatments

Other: Waiting List
Device: CEREBRUM VR

Study type

Interventional

Funder types

Other

Identifiers

NCT07427485
29475 - 02/03/2025

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18 to 67 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

Immersive Virtual Reality-Based Cognitive Rehabilitation
Experimental group
Description:
patients will undergo IVR-based cognitive rehabilitation sessions (about 45minutes) for 12 weeks as an adjunct to the Therapy as Usual (TAU)
Treatment:
Device: CEREBRUM VR
Waiting List
Other group
Description:
The patients randomized to the waiting list arm will not undergo IVR rehabilitation, but rather continue with TAU
Treatment:
Other: Waiting List

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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