Schizoaffective Disorder, SCHIZOPHRENIA 1 (Disorder)
Conditions
Keywords
rehabilitation, cognitive remediation, community mental health
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.
Interventions
DEVICECEREBRUM 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.
OTHERWaiting 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
Azienda Sanitaria Locale Napoli 3 Sud, UOCSM Torre del Greco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 67 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Positive and Negative Syndrome Scale (PANSS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Digit Symbol Substitution Test (DSST) | 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. |
| Animal Naming Test (ANT) | 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. |
| Trail Making Test - A (TMT) | 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. |
| Simple Reaction Time (SRT) | 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. |
| Choice Reaction Time (CRT) | 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. |
| Global Assessment of Functioning (GAF) | 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. |
Countries
Italy
Outcome results
None listed