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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
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| Waiting List | Other | The patients randomized to the waiting list arm will not undergo IVR rehabilitation, but rather continue with TAU |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Positive and Negative Syndrome Scale (PANSS) | 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.) | From enrollment to the end of treatment at 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Digit Symbol Substitution Test (DSST) | 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. | From enrollment to the end of treatment at 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Azienda Sanitaria Locale Napoli 3 Sud Unità Operativa Complessa Salute Mentale Torre del Greco/Ercolano | Torre del Greco | Naples | 80059 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | 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. | ||
| 38999451 | 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. |
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The decision regarding the possibility of sharing of individual participant data (IPD) will be made in accordance with institutional policies, applicable data protection regulations (including GDPR), and ethical approvals governing the study. Given the pilot nature of the trial and the collection of sensitive health-related data, any potential data sharing will require careful evaluation to ensure adequate anonymization and protection of participant confidentiality.
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|
| 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. |
|
| Animal Naming Test (ANT) | 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. | From enrollment to the end of treatment at 12 weeks |
| Trail Making Test - A (TMT) | 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. | From enrollment to the end of treatment at 12 weeks |
| Simple Reaction Time (SRT) | 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. | From enrollment to the end of treatment at 12 weeks |
| Choice Reaction Time (CRT) | 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. | From enrollment to the end of treatment at 12 weeks |
| Global Assessment of Functioning (GAF) | 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. | From enrollment to the end of treatment at 12 weeks |
| ID | Term |
|---|---|
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D014850 | Waiting Lists |
| ID | Term |
|---|---|
| D001071 | Appointments and Schedules |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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