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NCT07632989Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 8 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
80 (actual)
First submitted
2 Jun 2026
Start date
1 Sept 2025
Primary completion date
1 Jun 2026
Lead sponsor
Università degli Studi di Brescia
NCT number
NCT07632989

What you commit to

  • Study type: Interventional
  • Participants enrolled: 80
  • From 1 Sept 2025 to the primary completion date, 1 Jun 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • neurological disorders

Other

  • intellectual disability
  • inability to participate in VR-based interventions due to medical or sensory limitations.

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
ASST Spedali Civili di Brescia - Department of Mental Health and Addiction Services
Coordinator of this site? Confirm its status
BresciaItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.