Mood DisordersNCT05070065

Virtual Reality VAlidation Tool for Cognitive Rehabilitation, Oriented Project for People With Psychosocial Disabilieties

A study testing Cognitive remedy intervention with virtual reality (CEREBRUM) in people with Mood Disorders, run by University of Cagliari at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Mood Disorders
What is being tested?: Cognitive remedy intervention with virtual reality (CEREBRUM)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteItaly
Study dates: 10 Nov 2021to 10 Feb 2022
Phase: Interventional
Are there results?: None posted in the registry

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 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age from 18 to 75;
Diagnosis of psychosis and / or mood disorder according to DSM-IV (American Psychiatric Association, 2000).
both sexes;
users who sign the informed consent;
users under protection for which the informed consent is signed by the guardian

Who cannot join

The non-satisfaction of the inclusion criteria;
The diagnosis of epilepsy or serious eye diseases, due to the risk associated with the excessive stimulation of virtual reality

Trial locations and contacts

1 site in 1 country.

Italy1 site

P.O. San Giovanni di Dio, AOU Cagliari
Cagliari, 09100

Other trials in Italy

About this study

Official title: VIVA-CORE! Virtual Reality VAlidation Tool for Cognitive Rehabilitation, a REcovery Oriented Project for People With Psychosocial Disabilieties: Protocol of Randomize Clinical Trial

Randomized controlled open-label cross-over clinical feasibility study with waiting list, 60 people will be recruited from the Consultation and Psychosomatic Psychiatry Center of the University Hospital of Cagliari (San Giovanni di Dio Civil Hospital) with a diagnosis of mental disorder. The investigators propose a VR intervention of 3 months with 2 weekly session of CEREBRUM (cognitive remedy intervention with virtual reality) first to the group A and then to the group B.

Read the detailed description

Background: Cognitive remedial interventions have been found to be effective in the treatment of various psycho-social disorders. The use of Virtual reality as a rehabilitation tool has been showing various scientific evidences in recent years like in cardiovascular, neurological and musculoskeletal rehabilitation. In mental health evidence they seem to be concentrated in the rehabilitation of social cognition in people with schizophrenia diagnosis and psychotherapy. The aim of this study is to evaluate the feasibility and the effectiveness of the first Cognitive Remedial toll in Virtual Reality (CEREBRUM) for people that has experienced in mental health.

Methods: Randomized controlled open-label cross-over clinical feasibility study with waiting list, 60 people will be recruited from the Consultation and Psychosomatic Psychiatry Center of the University Hospital of Cagliari (San Giovanni di Dio Civil Hospital) with a diagnosis of mental disorder. The investigators propose a intervention of 3 months with 2 weekly session of CEREBRUM first to the group A and then to the group B

Conditions: Mood Disorders
Being tested: Cognitive remedy intervention with virtual reality (CEREBRUM)
Keywords: Virtual Reality, Remediation, Mental Health, Recovery
Medical subject headings: Mood Disorders, Psychological Well-Being

What participants receive

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

Cognitive remedy intervention with virtual reality (CEREBRUM)Device
Cognitive Remedial method Virtual Reality (CEREBRUM)

Study groups in NCT05070065
Study group	Role	What they receive
virtual reality	Experimental	The experimental group A receives the cognitive remedy intervention with virtual reality (CEREBRUM) Receives: Device: Cognitive remedy intervention with virtual reality (CEREBRUM)
waiting list	Other	waiting list Receives: Device: Cognitive remedy intervention with virtual reality (CEREBRUM)

What is being measured

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

Memory
Rey's Figure Test Word's Figure Test Digit Span Forward and Backward Test Test of the Tale
Measured: All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)
Monitoring Side effects of Virtual Reality
Questionnaire (Qualitative)
Measured: During the first VR session - At 1 month (after 8 sessions) - T1 (at 3 months from baseline)
Attention
Matrix Test Digit Symbol Substitution Test
Measured: All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)
Executive functions
Trial Making Test Verbal Phonological and Semantic Fluency Test Cognitive Estimation Test - CET Stroop Test Frontal Assessment Battery - FAB
Measured: All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)

Secondary outcomes (6)

Quality of Life
Short Form Healthy Survey Questionnaire - SF-12
Measured: All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)
Alexithymia
Toronto Alexithymia Scale - TAS-20
Measured: All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)
Anxiety
Self Anxiety Rating Scale - SAS
Measured: All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)
Depression
The Patient Health Questionnaire - PHQ-9
Measured: All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)
Biological Rythms
Biological Rythms Interview of Assesment in Neuropsychiatry - BRIAN
Measured: All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)
General and social functioning
Health of the Nation Outcome Scales - HoNOS
Measured: All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)

Timeline

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

10 Nov 202110 Feb 2022

First posted6 Oct 2021
Study start10 Nov 2021
Primary completion10 Feb 2022
Study completion10 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Mood DisordersStudies 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: Crossover
Model description: Randomized controlled open-label cross-over clinical feasibility study with waiting list
Masking: Single blind
Who is masked: Participant
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05070065
Sponsor's protocol ID: Prot. PG/2020/7577
Status last verified: Mar 2023
First submitted: 21 Jul 2021
Last updated: 20 Mar 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Sancassiani F, Perra A, Galetti A, Di Natale L, De Lorenzo V, Lorrai S, Kalcev G, Pintus E, Cantone E, Nonnis M, Nardi AE, Montisci R, Primavera D. Alexithymia and Bipolar Disorder: Virtual Reality Could Be a Useful Tool for the Treatment and Prevention of These Conditions in People with a Physical Comorbidity. J Clin Med. 2024 Oct 18;13(20):6206. doi: 10.3390/jcm13206206.
PubMed 39458156
Perra A, De Lorenzo V, Zaccheddu R, Locci A, Piludu F, Preti A, Di Natale L, Galetti A, Nardi AE, Cossu G, Sancassiani F, Barbato S, Cesaretti O, Kurotshka PK, Carta MG. Cognitive Remediation Virtual Reality Tool a Recovery-Oriented Project for People with Bipolar Disorder: Protocol of a Feasibility Randomized Clinical Trial. Clin Pract Epidemiol Ment Health. 2022 Oct 6;18:e174501792208220. doi: 10.2174/17450179-v18-e2208220. eCollection 2022.
PubMed 37274852
Perra A, Galetti A, Zaccheddu R, Locci A, Piludu F, Preti A, Primavera D, Di Natale L, Nardi AE, Kurotshka PK, Cossu G, Sancassiani F, Stella G, De Lorenzo V, Zreik T, Carta MG. A Recovery-Oriented Program for People with Bipolar Disorder through Virtual Reality-Based Cognitive Remediation: Results of a Feasibility Randomized Clinical Trial. J Clin Med. 2023 Mar 9;12(6):2142. doi: 10.3390/jcm12062142.
PubMed 36983145

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

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All Mood Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: VIVA-CORE! Virtual Reality VAlidation Tool for Cognitive Rehabilitation, a REcovery Oriented Project for People With Psychosocial Disabilieties: Protocol of Randomize Clinical Trial
ClinicalTrials.gov ID: NCT05070065
Acronym / sponsor ID: Prot. PG/2020/7577
Conditions: Mood Disorders
Keywords: Virtual Reality, Remediation, Mental Health, Recovery
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: University of CagliariUniversity, hospital or other
Study start: 10 Nov 2021 (actual)
Primary completion: 10 Feb 2022 (actual)
Study completion: 10 Feb 2022 (actual)
First posted: 6 Oct 2021 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2
Model description: Randomized controlled open-label cross-over clinical feasibility study with waiting list

Arm	Type	Receives
virtual reality	Experimental	Device: Cognitive remedy intervention with virtual reality (CEREBRUM)The experimental group A receives the cognitive remedy intervention with virtual reality (CEREBRUM)
waiting list	Other	Device: Cognitive remedy intervention with virtual reality (CEREBRUM)waiting list

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age from 18 to 75;
Diagnosis of psychosis and / or mood disorder according to DSM-IV (American Psychiatric Association, 2000).
both sexes;
users who sign the informed consent;
users under protection for which the informed consent is signed by the guardian

Key exclusion criteria (2 listed)

The non-satisfaction of the inclusion criteria;
The diagnosis of epilepsy or serious eye diseases, due to the risk associated with the excessive stimulation of virtual reality

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
Cognitive remedy intervention with virtual reality (CEREBRUM)Cognitive Remedial method Virtual Reality (CEREBRUM)	Device	virtual reality, waiting list

Primary outcome

Memory
Time frame: All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)
Rey's Figure Test Word's Figure Test Digit Span Forward and Backward Test Test of the Tale
Monitoring Side effects of Virtual Reality
Time frame: During the first VR session - At 1 month (after 8 sessions) - T1 (at 3 months from baseline)
Questionnaire (Qualitative)
Attention
Time frame: All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)
Matrix Test Digit Symbol Substitution Test
Executive functions
Time frame: All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)
Trial Making Test Verbal Phonological and Semantic Fluency Test Cognitive Estimation Test - CET Stroop Test Frontal Assessment Battery - FAB

6 secondary outcomes

Quality of Life
Time frame: All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)
Alexithymia
Time frame: All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)
Anxiety
Time frame: All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)
Depression
Time frame: All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)
Biological Rythms
Time frame: All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)
General and social functioning
Time frame: All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
Derived from this study: PubMed 39458156Sancassiani F, Perra A, Galetti A, Di Natale L, De Lorenzo V, Lorrai S, Kalcev G, Pintus E, Cantone E, Nonnis M, Nardi AE, Montisci R, Primavera D. Alexithymia and Bipolar Disorder: Virtual Reality Could Be a Useful Tool for the Treatment and Prevention of These Conditions in People with a Physical Comorbidity. J Clin Med. 2024 Oct 18;13(20):6206. doi: 10.3390/jcm13206206.
Derived from this study: PubMed 37274852Perra A, De Lorenzo V, Zaccheddu R, Locci A, Piludu F, Preti A, Di Natale L, Galetti A, Nardi AE, Cossu G, Sancassiani F, Barbato S, Cesaretti O, Kurotshka PK, Carta MG. Cognitive Remediation Virtual Reality Tool a Recovery-Oriented Project for People with Bipolar Disorder: Protocol of a Feasibility Randomized Clinical Trial. Clin Pract Epidemiol Ment Health. 2022 Oct 6;18:e174501792208220. doi: 10.2174/17450179-v18-e2208220. eCollection 2022.
Derived from this study: PubMed 36983145Perra A, Galetti A, Zaccheddu R, Locci A, Piludu F, Preti A, Primavera D, Di Natale L, Nardi AE, Kurotshka PK, Cossu G, Sancassiani F, Stella G, De Lorenzo V, Zreik T, Carta MG. A Recovery-Oriented Program for People with Bipolar Disorder through Virtual Reality-Based Cognitive Remediation: Results of a Feasibility Randomized Clinical Trial. J Clin Med. 2023 Mar 9;12(6):2142. doi: 10.3390/jcm12062142.
Individual participant dataSharing planned: No

Related trials for Mood Disorders

RecruitingPhase 3
A Study of Brenipatide (LY3537031) in Adult Participants With Major Depressive Disorder
Depressive Disorder, Major
Recruiting
EEG-Guided Transcranial Magnetic Stimulation for Adults With Depression
Major Depressive Disorder (MDD), Treatment Resistant Depression
Recruiting
Defining Neurobiological Links Between Substance Use and Mental Illness
Major Depressive Disorder, Substance Use Disorder
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine
Mania, Bipolar Disorder
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Esketamine for Reduction of Symptoms of Major Depressive Disorder
Depressive Disorder, Major

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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive remedy intervention with virtual reality (CEREBRUM) in people with Mood Disorders, run by University of Cagliari at 1 site in Italy.

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 5 inclusion and 2 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: finished, as of the sponsor's last update on 20 Mar 2023. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Memory (time frame: All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)). The study lists 4 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 NCT05070065, which also lists 3 linked publications.

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 20 Mar 2023.