Bipolar Disorder (BD), Schizophrenia Spectrum Disorders (SSD)
Conditions
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.
Interventions
BEHAVIORALVirtual 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).
OTHERTreatment as Usual (TAU)
Standard clinical care including pharmacological treatment and case management according to routine clinical practice.
Sponsors
Università degli Studi di Brescia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in cognitive performance measured by MATRICS Consensus Cognitive Battery (MCCB) total score | 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. |
| Change in psychosocial functioning measured by Personal and Social Performance (PSP) scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Neurobiological correlates assessed by functional magnetic resonance imaging (fMRI) in patients with a diagnosis of SSD | Baseline | — |
| Changes in neuroplasticity-related biomarkers (BDNF, VEGF, DYRK1A) | 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. |
Countries
Italy
Contacts
STUDY_CHAIRAntonio Vita, MD, PhD
Università degli Studi di Brescia
Outcome results
None listed