Virtual Reality-Based Cognitive Remediation in Schizophrenia and Bipolar Disorder
FULL-MINDSET- Fully Immersive Virtual Reality-based Cognitive Training in Schizophrenia and Bipolar Disorder: a Single Blind Randomized Controlled Trial in a Real-world Setting
This randomized controlled trial aims to evaluate the effectiveness of a virtual reality-based cognitive remediation (VRCR) intervention in improving cognitive performance and psychosocial functioning in individuals with schizophrenia spectrum disorders (SSD) and bipolar disorder (BD).
A total of 80 participants (40 with SSD and 40 with BD) will be randomly assigned in a 1:1 ratio to receive either VRCR or treatment as usual (TAU). The VRCR intervention will be delivered using the CEREBRUM platform and will consist of 45-minute sessions administered twice weekly for 12 weeks under the supervision of trained therapists.
The primary outcomes are changes in cognitive performance and psychosocial functioning, assessed using the MATRICS Consensus Cognitive Battery (MCCB) and the Personal and Social Performance (PSP) scale, respectively. Secondary outcomes include clinical symptom severity, assessed with validated rating scales, and neurobiological correlates, including functional magnetic resonance imaging (fMRI) and genetic biomarkers.
Assessments will be conducted at baseline, at 3 months (post-intervention), and at 6 months (follow-up). fMRI assessments will be conducted at baseline in patients with schizophrenia spectrum disorders, whereas peripheral blood samples for genetic marker analyses will be collected at baseline and at the 3-month follow-up in patients with SSD and BD. This study is expected to provide evidence on the feasibility, acceptability, and effectiveness of VR-based cognitive remediation in SSD and BD, as well as insights into the neurobiological mechanisms underlying cognitive and functional improvements.
Descripción general del estudio
Estado
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Lombardy
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Brescia, Lombardy, Italia, 25123
- ASST Spedali Civili di Brescia - Department of Mental Health and Addiction Services
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Age ≥ 18 years
- Diagnosis of schizophrenia spectrum disorder or bipolar disorder (DSM-5)
- Clinical stability for at least 3 months
- Ability to provide informed consent
Exclusion Criteria:
- neurological disorders
- intellectual disability
- inability to participate in VR-based interventions due to medical or sensory limitations.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Participants with diagnosis of schizophrenia receiving VRCR
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Participants in the VRCR group will receive individualized cognitive training using the CEREBRUM platform (IDEGO, Rome, Italy). CEREBRUM is an immersive virtual reality software where the user wearing the viewer sees a virtual environment that can be explored at 360°; it consists of 52 ecologically valid exercises of varying difficulty: 22 belonging to the Memory, and Learning Module, 10 to the Cognitive Estimates Module and 20 to the Attention and Working Memory Module. The difficulty of exercises is adaptable to provide adequately implement scaffolding and errorless learning principles, and the exercises require active interaction with the therapist. The software is compatible with the Oculus Go virtual reality viewer, a device with CE obligation. The program consists of 12 weeks of individual training, delivered twice weekly in 45-minute sessions in a controlled setting, from T0 (baseline) to T1 (3 months after T0). |
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Comparador activo: Participants with diagnosis of schizophrenia receiving standard clinical care
Participants receiving standard clinical care, including pharmacological treatment and case management
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Standard clinical care including pharmacological treatment and case management according to routine clinical practice.
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Experimental: Participants with diagnosis of bipolar disorder receiving VRCR
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Participants in the VRCR group will receive individualized cognitive training using the CEREBRUM platform (IDEGO, Rome, Italy). CEREBRUM is an immersive virtual reality software where the user wearing the viewer sees a virtual environment that can be explored at 360°; it consists of 52 ecologically valid exercises of varying difficulty: 22 belonging to the Memory, and Learning Module, 10 to the Cognitive Estimates Module and 20 to the Attention and Working Memory Module. The difficulty of exercises is adaptable to provide adequately implement scaffolding and errorless learning principles, and the exercises require active interaction with the therapist. The software is compatible with the Oculus Go virtual reality viewer, a device with CE obligation. The program consists of 12 weeks of individual training, delivered twice weekly in 45-minute sessions in a controlled setting, from T0 (baseline) to T1 (3 months after T0). |
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Comparador activo: Participants with diagnosis of bipolar disorder receiving standard clinical care
Participants receiving standard clinical care, including pharmacological treatment and case management
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Standard clinical care including pharmacological treatment and case management according to routine clinical practice.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in cognitive performance measured by MATRICS Consensus Cognitive Battery (MCCB) total score
Periodo de tiempo: Baseline, 3 months (end of the intervention), and 6 months
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Cognitive performance will be assessed using the MATRICS Consensus Cognitive Battery (MCCB), a standardized neuropsychological battery evaluating processing speed, attention/vigilance, working memory, verbal learning, visual learning, reasoning/problem solving, and social cognition.
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Baseline, 3 months (end of the intervention), and 6 months
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Change in psychosocial functioning measured by Personal and Social Performance (PSP) scale
Periodo de tiempo: Baseline, 3 months (end of the intervention), and 6 months
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Psychosocial functioning will be assessed using the Personal and Social Performance (PSP) scale, which evaluates socially useful activities, personal and social relationships, self-care, and disturbing or aggressive behaviors.
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Baseline, 3 months (end of the intervention), and 6 months
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change in Clinical Global Impression (CGI) severity score
Periodo de tiempo: Baseline, 3 months (end of the intervention), and 6 months
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Baseline, 3 months (end of the intervention), and 6 months
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Change in Positive and Negative Syndrome Scale (PANSS) total score in participants with schizophrenia spectrum disorders
Periodo de tiempo: Baseline, 3 months (end of the intervention), and 6 months
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Baseline, 3 months (end of the intervention), and 6 months
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Change in Brief Negative Symptom Scale (BNSS) total score in participants with schizophrenia spectrum disorders
Periodo de tiempo: Baseline, 3 months (end of the intervention), and 6 months
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Baseline, 3 months (end of the intervention), and 6 months
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Change in Hamilton Depression Rating Scale (HAM-D) total score in participants with bipolar disorder
Periodo de tiempo: Baseline, 3 months (end of the intervention), and 6 months
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Baseline, 3 months (end of the intervention), and 6 months
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Change in Young Mania Rating Scale (YMRS) total score in participants with bipolar disorder
Periodo de tiempo: Baseline, 3 months (end of the intervention), and 6 months
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Baseline, 3 months (end of the intervention), and 6 months
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Neurobiological correlates assessed by functional magnetic resonance imaging (fMRI) in patients with a diagnosis of SSD
Periodo de tiempo: Baseline
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Baseline
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Changes in neuroplasticity-related biomarkers (BDNF, VEGF, DYRK1A)
Periodo de tiempo: Baseline to 3 months (end of the intervention)
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Blood samples will be analyzed to assess biomarkers associated with neuroplasticity and cognitive functioning in patients with SSD and BD.
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Baseline to 3 months (end of the intervention)
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Antonio Vita, MD, PhD, Università degli Studi di Brescia
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- FULL-MINDSET
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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