Cognitive Rehabilitation With Immersive Virtual Reality (IVR) in Schizophrenia: a Pilot Randomized Waiting List Controlled Feasibility Study
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Azienda Sanitaria Locale Napoli 3 Sud, UOCSM Torre del Greco
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Positive and Negative Syndrome Scale (PANSS)
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 67 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Immersive Virtual Reality-Based Cognitive Rehabilitation
patients will undergo IVR-based cognitive rehabilitation sessions (about 45minutes) for 12 weeks as an adjunct to the Therapy as Usual (TAU)
Intervention: CEREBRUM VR (Device)
Waiting List
The patients randomized to the waiting list arm will not undergo IVR rehabilitation, but rather continue with TAU
Intervention: Waiting List (Other)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Global Assessment of Functioning (GAF)(From enrollment to the end of treatment at 12 weeks)
- 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)