Virtual Reality-Based Cognitive Remediation in Schizophrenia and Bipolar Disorder

NCT07632989 | Active Not Recruiting DMC

• 1 other identifier: FULL-MINDSET
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bipolar Disorder (BD); Schizophrenia Spectrum Disorders (SSD)

Outcome Measures

Primary Outcomes (2)

• Change in cognitive performance measured by MATRICS Consensus Cognitive Battery (MCCB) total score

  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

  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

Secondary Outcomes (7)

• Change in Clinical Global Impression (CGI) severity score

  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

  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

  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

  Baseline, 3 months (end of the intervention), and 6 months

• Change in Young Mania Rating Scale (YMRS) total score in participants with bipolar disorder

  Baseline, 3 months (end of the intervention), and 6 months

Study Arms (4)

Participants with diagnosis of schizophrenia receiving VRCR

EXPERIMENTAL

Behavioral: Virtual Reality Cognitive Remediation (VRCR)

Participants with diagnosis of schizophrenia receiving standard clinical care

ACTIVE COMPARATOR

Participants receiving standard clinical care, including pharmacological treatment and case management

Other: Treatment as Usual (TAU)

Participants with diagnosis of bipolar disorder receiving VRCR

EXPERIMENTAL

Behavioral: Virtual Reality Cognitive Remediation (VRCR)

Participants with diagnosis of bipolar disorder receiving standard clinical care

ACTIVE COMPARATOR

Participants receiving standard clinical care, including pharmacological treatment and case management

Other: Treatment as Usual (TAU)

Interventions

Virtual Reality Cognitive Remediation (VRCR) BEHAVIORAL

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).

Participants with diagnosis of bipolar disorder receiving VRCR; Participants with diagnosis of schizophrenia receiving VRCR

Treatment as Usual (TAU) OTHER

Standard clinical care including pharmacological treatment and case management according to routine clinical practice.

Participants with diagnosis of bipolar disorder receiving standard clinical care; Participants with diagnosis of schizophrenia receiving standard clinical care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Università degli Studi di Brescia: lead

Study Sites (1)

ASST Spedali Civili di Brescia - Department of Mental Health and Addiction Services

Brescia, Lombardy, 25123, Italy

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Antonio Vita, MD, PhD

  Università degli Studi di Brescia

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co - Principal Investigator

Model Details: This study is designed as a single-blind, randomized controlled trial. A total of 80 participants will be recruited, comprising 40 individuals diagnosed with SSD and 40 with BD, according to DSM-5 criteria Participant recruitment and assessment will be performed in the Department of Mental Health and Addiction Services of the Spedali Civili Hospital, Brescia, Italy. Participants will be randomized in a 1:1 ratio to either the VRCR intervention group or a treatment as usual (TAU) control group using a computer-generated randomization sequence. The study will include neuropsychological, clinical, genetic and daily life functioning assessments at three timepoints: baseline (T0), post-intervention at 3 months (T1), and at a follow-up at 6 months (T2); additionally, functional Magnetic Resonance Imaging (fMRI) scans will be conducted at T0 in patients with SSD and peripheral blood samples for genetic marker analyses will be collected at baseline and at T1 in patients with SSD and BD.

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 8, 2026
• Study Start: September 1, 2025
• Primary Completion: June 1, 2026
• Study Completion: June 1, 2026
• Last Updated: June 8, 2026

Record last verified: 2025-08

Locations

IT (1)