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Virtual Reality-Based Cognitive Remediation in Schizophrenia and Bipolar Disorder

2 juni 2026 bijgewerkt door: Gabriele Nibbio, Università degli Studi di Brescia

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.

Studie Overzicht

Toestand

Actief, niet wervend

Conditie

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Werkelijk)

80

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Italië
    • Lombardy
      • Brescia, Lombardy, Italië, 25123
        • ASST Spedali Civili di Brescia - Department of Mental Health and Addiction Services

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Participants with diagnosis of schizophrenia receiving VRCR
Gedragsmatig: Virtual Reality Cognitive Remediation (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).
Actieve vergelijker: Participants with diagnosis of schizophrenia receiving standard clinical care
Participants receiving standard clinical care, including pharmacological treatment and case management
Ander: Treatment as Usual (TAU)
Standard clinical care including pharmacological treatment and case management according to routine clinical practice.
Experimenteel: Participants with diagnosis of bipolar disorder receiving VRCR
Gedragsmatig: Virtual Reality Cognitive Remediation (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).
Actieve vergelijker: Participants with diagnosis of bipolar disorder receiving standard clinical care
Participants receiving standard clinical care, including pharmacological treatment and case management
Ander: Treatment as Usual (TAU)
Standard clinical care including pharmacological treatment and case management according to routine clinical practice.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in cognitive performance measured by MATRICS Consensus Cognitive Battery (MCCB) total score
Tijdsspanne: 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
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in Clinical Global Impression (CGI) severity score
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: Baseline
Baseline
Changes in neuroplasticity-related biomarkers (BDNF, VEGF, DYRK1A)
Tijdsspanne: 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)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Università degli Studi di Brescia

Onderzoekers

  • Studie stoel: Antonio Vita, MD, PhD, Università degli Studi di Brescia

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 september 2025

Primaire voltooiing (Geschat)

1 juni 2026

Studie voltooiing (Geschat)

1 juni 2026

Studieregistratiedata

Eerst ingediend

2 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

2 juni 2026

Eerst geplaatst (Werkelijk)

8 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

8 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

2 juni 2026

Laatst geverifieerd

1 augustus 2025

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • FULL-MINDSET

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Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

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