Bipolar Disorder (BD)NCT07632989

Virtual Reality-Based Cognitive Remediation in Schizophrenia and Bipolar Disorder

A study testing Virtual Reality Cognitive Remediation (VRCR) and Treatment as Usual (TAU) in people with Bipolar Disorder (BD) and Schizophrenia Spectrum Disorders (SSD), run by Università degli Studi di Brescia at 1 site in Italy.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial 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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Bipolar Disorder (BD), Schizophrenia Spectrum Disorders (SSD)
What is being tested?: Virtual Reality Cognitive Remediation (VRCR) and Treatment as Usual (TAU)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 80 participants
Where: 1 siteItaly
Study dates: 1 Sep 2025to 1 Jun 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Italy1 site

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

Other trials in Italy

About this study

Official title: 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

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)
Being tested: Virtual Reality Cognitive Remediation (VRCR), Treatment as Usual (TAU)
Medical subject headings: Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Virtual Reality Cognitive Remediation (VRCR)Behavioural
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).
Treatment as Usual (TAU)Other
Standard clinical care including pharmacological treatment and case management according to routine clinical practice.

Study groups in NCT07632989
Study group	Role	What they receive
Participants with diagnosis of schizophrenia receiving VRCR	Experimental	Not described Receives: 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 Receives: Other: Treatment as Usual (TAU)
Participants with diagnosis of bipolar disorder receiving VRCR	Experimental	Not described Receives: 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 Receives: Other: Treatment as Usual (TAU)

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (7)

Change in Clinical Global Impression (CGI) severity score
Measured: 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
Measured: 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
Measured: 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
Measured: Baseline, 3 months (end of the intervention), and 6 months
Change in Young Mania Rating Scale (YMRS) total score in participants with bipolar disorder
Measured: 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
Measured: Baseline
Changes in neuroplasticity-related biomarkers (BDNF, VEGF, DYRK1A)
Blood samples will be analyzed to assess biomarkers associated with neuroplasticity and cognitive functioning in patients with SSD and BD.
Measured: Baseline to 3 months (end of the intervention)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Sep 20251 Jun 2026

First posted8 Jun 2026
Study start1 Sep 2025
Primary completion1 Jun 2026 (estimated)
Study completion1 Jun 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Bipolar Disorder (BD)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 80 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07632989
Sponsor's protocol ID: FULL-MINDSET
Status last verified: Aug 2025
First submitted: 2 Jun 2026
Last updated: 8 Jun 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
RecruitingObservational study
A Prospective Study of Anxiety, Depression, and Bipolar Disorder in People
Anxiety Disorders, Depressive Disorder
Active, not recruiting
Functional Remediation for Older Adults With Bipolar Disorder
Bipolar Disorder
Enrolling by invitation
Incentives and Long-Acting Injectable Adherence After Involuntary Hospitalization
Schizophrenia Disorder, Schizoaffective Disorder

All Bipolar Disorder (BD) trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT07632989
Acronym / sponsor ID: FULL-MINDSET
Conditions: Bipolar Disorder (BD), Schizophrenia Spectrum Disorders (SSD)
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 80 participants (actual)
Lead sponsor: Università degli Studi di BresciaUniversity, hospital or other
Study start: 1 Sep 2025 (actual)
Primary completion: 1 Jun 2026 (estimated)
Study completion: 1 Jun 2026 (estimated)
First posted: 8 Jun 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 4
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.

Arm	Type	Receives
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	Other: Treatment as Usual (TAU)Participants receiving standard clinical care, including pharmacological treatment and case management
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	Other: Treatment as Usual (TAU)Participants receiving standard clinical care, including pharmacological treatment and case management

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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).	Behavioural	Participants with diagnosis of bipolar disorder receiving VRCR, Participants with diagnosis of schizophrenia receiving VRCR
Treatment as Usual (TAU)Standard clinical care including pharmacological treatment and case management according to routine clinical practice.	Other	Participants with diagnosis of bipolar disorder receiving standard clinical care, Participants with diagnosis of schizophrenia receiving standard clinical care

Primary outcome

Change in cognitive performance measured by MATRICS Consensus Cognitive Battery (MCCB) total score
Time frame: 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
Time frame: 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.

7 secondary outcomes

Change in Clinical Global Impression (CGI) severity score
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline, 3 months (end of the intervention), and 6 months
Change in Young Mania Rating Scale (YMRS) total score in participants with bipolar disorder
Time frame: 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
Time frame: Baseline
Changes in neuroplasticity-related biomarkers (BDNF, VEGF, DYRK1A)
Time frame: Baseline to 3 months (end of the intervention)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
Individual participant dataSharing planned: Undecided

Related trials for Bipolar Disorder (BD)

Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Recruiting
Affective Cognitive Training in Mood Disorders and High-risk Relatives
Major Depressive Disorder (MDD), Bipolar Disorder (BD)
RecruitingObservational study
A Prospective Study of Anxiety, Depression, and Bipolar Disorder in People
Anxiety Disorders, Depressive Disorder
Active, not recruiting
Functional Remediation for Older Adults With Bipolar Disorder
Bipolar Disorder
Enrolling by invitation
Incentives and Long-Acting Injectable Adherence After Involuntary Hospitalization
Schizophrenia Disorder, Schizoaffective Disorder

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Antonio Vita, MD, PhD study chair

Università degli Studi di Brescia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in cognitive performance measured by MATRICS Consensus Cognitive Battery (MCCB) total score (time frame: Baseline, 3 months (end of the intervention), and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07632989.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.