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.
A tanulmány áttekintése
Állapot
Beavatkozás / kezelés
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
-
-
Lombardy
-
Brescia, Lombardy, Olaszország, 25123
- ASST Spedali Civili di Brescia - Department of Mental Health and Addiction Services
-
-
Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
- Felnőtt
- Idősebb felnőtt
Egészséges önkénteseket fogad
Leírás
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.
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Kezelés
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Kettős
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: Participants with diagnosis of schizophrenia receiving VRCR
|
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). |
|
Aktív összehasonlító: Participants with diagnosis of schizophrenia receiving standard clinical care
Participants receiving standard clinical care, including pharmacological treatment and case management
|
Standard clinical care including pharmacological treatment and case management according to routine clinical practice.
|
|
Kísérleti: Participants with diagnosis of bipolar disorder receiving VRCR
|
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). |
|
Aktív összehasonlító: Participants with diagnosis of bipolar disorder receiving standard clinical care
Participants receiving standard clinical care, including pharmacological treatment and case management
|
Standard clinical care including pharmacological treatment and case management according to routine clinical practice.
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Change in cognitive performance measured by MATRICS Consensus Cognitive Battery (MCCB) total score
Időkeret: Baseline, 3 months (end of the intervention), and 6 months
|
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.
|
Baseline, 3 months (end of the intervention), and 6 months
|
|
Change in psychosocial functioning measured by Personal and Social Performance (PSP) scale
Időkeret: Baseline, 3 months (end of the intervention), and 6 months
|
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.
|
Baseline, 3 months (end of the intervention), and 6 months
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Change in Clinical Global Impression (CGI) severity score
Időkeret: Baseline, 3 months (end of the intervention), and 6 months
|
Baseline, 3 months (end of the intervention), and 6 months
|
|
|
Change in Positive and Negative Syndrome Scale (PANSS) total score in participants with schizophrenia spectrum disorders
Időkeret: Baseline, 3 months (end of the intervention), and 6 months
|
Baseline, 3 months (end of the intervention), and 6 months
|
|
|
Change in Brief Negative Symptom Scale (BNSS) total score in participants with schizophrenia spectrum disorders
Időkeret: Baseline, 3 months (end of the intervention), and 6 months
|
Baseline, 3 months (end of the intervention), and 6 months
|
|
|
Change in Hamilton Depression Rating Scale (HAM-D) total score in participants with bipolar disorder
Időkeret: Baseline, 3 months (end of the intervention), and 6 months
|
Baseline, 3 months (end of the intervention), and 6 months
|
|
|
Change in Young Mania Rating Scale (YMRS) total score in participants with bipolar disorder
Időkeret: Baseline, 3 months (end of the intervention), and 6 months
|
Baseline, 3 months (end of the intervention), and 6 months
|
|
|
Neurobiological correlates assessed by functional magnetic resonance imaging (fMRI) in patients with a diagnosis of SSD
Időkeret: Baseline
|
Baseline
|
|
|
Changes in neuroplasticity-related biomarkers (BDNF, VEGF, DYRK1A)
Időkeret: Baseline to 3 months (end of the intervention)
|
Blood samples will be analyzed to assess biomarkers associated with neuroplasticity and cognitive functioning in patients with SSD and BD.
|
Baseline to 3 months (end of the intervention)
|
Együttműködők és nyomozók
Szponzor
Nyomozók
- Tanulmányi szék: Antonio Vita, MD, PhD, Università degli Studi di Brescia
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete (Tényleges)
Elsődleges befejezés (Becsült)
A tanulmány befejezése (Becsült)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- FULL-MINDSET
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
Gyógyszer- és eszközinformációk, tanulmányi dokumentumok
Egy amerikai FDA által szabályozott gyógyszerkészítményt tanulmányoz
Egy amerikai FDA által szabályozott eszközterméket tanulmányoz
Ezt az információt közvetlenül a clinicaltrials.gov webhelyről szereztük be, változtatás nélkül. Ha bármilyen kérése van vizsgálati adatainak módosítására, eltávolítására vagy frissítésére, kérjük, írjon a következő címre: register@clinicaltrials.gov. Amint a változás bevezetésre kerül a clinicaltrials.gov oldalon, ez a webhelyünkön is automatikusan frissül. .