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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| virtual reality | Experimental | The experimental group A receives the cognitive remedy intervention with virtual reality (CEREBRUM) |
|
| waiting list | Other | waiting list |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive remedy intervention with virtual reality (CEREBRUM) | Device | Cognitive Remedial method Virtual Reality (CEREBRUM) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Memory | Rey's Figure Test Word's Figure Test Digit Span Forward and Backward Test Test of the Tale | 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) | During the first VR session - At 1 month (after 8 sessions) - T1 (at 3 months from baseline) |
| Attention | Matrix Test Digit Symbol Substitution Test | 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 | All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life | Short Form Healthy Survey Questionnaire - SF-12 | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| P.O. San Giovanni di Dio, AOU Cagliari | Cagliari | 09100 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39458156 | Derived | 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. | |
| 37274852 |
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| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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Randomized controlled open-label cross-over clinical feasibility study with waiting list
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people with psychosocial disabilities
Toronto Alexithymia Scale - TAS-20
| 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 | 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 | 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 | 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 | All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline) |
| Derived |
| 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. |
| 36983145 | Derived | 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. |