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Virtual Reality-Based Cognitive Remediation in Schizophrenia and Bipolar Disorder

2. juni 2026 opdateret af: 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.

Studieoversigt

Status

Aktiv, ikke rekrutterende

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Participants with diagnosis of schizophrenia receiving VRCR
Adfærdsmæssigt: 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).
Aktiv komparator: Participants with diagnosis of schizophrenia receiving standard clinical care
Participants receiving standard clinical care, including pharmacological treatment and case management
Andet: Treatment as Usual (TAU)
Standard clinical care including pharmacological treatment and case management according to routine clinical practice.
Eksperimentel: Participants with diagnosis of bipolar disorder receiving VRCR
Adfærdsmæssigt: 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).
Aktiv komparator: Participants with diagnosis of bipolar disorder receiving standard clinical care
Participants receiving standard clinical care, including pharmacological treatment and case management
Andet: Treatment as Usual (TAU)
Standard clinical care including pharmacological treatment and case management according to routine clinical practice.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in cognitive performance measured by MATRICS Consensus Cognitive Battery (MCCB) total score
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in Clinical Global Impression (CGI) severity score
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline
Baseline
Changes in neuroplasticity-related biomarkers (BDNF, VEGF, DYRK1A)
Tidsramme: 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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Università degli Studi di Brescia

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. september 2025

Primær færdiggørelse (Anslået)

1. juni 2026

Studieafslutning (Anslået)

1. juni 2026

Datoer for studieregistrering

Først indsendt

2. juni 2026

Først indsendt, der opfyldte QC-kriterier

2. juni 2026

Først opslået (Faktiske)

8. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juni 2026

Sidst verificeret

1. august 2025

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • FULL-MINDSET

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Kliniske forsøg med Bipolar lidelse (BD)

Kliniske forsøg med Virtual Reality Cognitive Remediation (VRCR)

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