Virtual Reality VAlidation Tool for Cognitive Rehabilitation, Oriented Project for People With Psychosocial Disabilieties
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: virtual reality The experimental group A receives the cognitive remedy intervention with virtual reality (CEREBRUM) |
Device: Cognitive remedy intervention with virtual reality (CEREBRUM)
Cognitive Remedial method Virtual Reality (CEREBRUM)
|
| Other: waiting list waiting list |
Device: Cognitive remedy intervention with virtual reality (CEREBRUM)
Cognitive Remedial method Virtual Reality (CEREBRUM)
|
Outcome Measures
Primary Outcome Measures
- Memory [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 [During the first VR session - At 1 month (after 8 sessions) - T1 (at 3 months from baseline)]
Questionnaire (Qualitative)
- Attention [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 [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
Secondary Outcome Measures
- Quality of Life [All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)]
Short Form Healthy Survey Questionnaire - SF-12
- Alexithymia [All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)]
Toronto Alexithymia Scale - TAS-20
- Anxiety [All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)]
Self Anxiety Rating Scale - SAS
- Depression [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 Patient Health Questionnaire - PHQ-9
- Biological Rythms [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 Interview of Assesment in Neuropsychiatry - BRIAN
- General and social functioning [All measure at: T0 (base line) -T1 (at 3 months from baseline) -T2 (at 6 months from baseline) -T3 (at 12 months from baseline)]
Health of the Nation Outcome Scales - HoNOS
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age from 18 to 75;
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Diagnosis of psychosis and / or mood disorder according to DSM-IV (American Psychiatric Association, 2000).
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both sexes;
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users who sign the informed consent;
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users under protection for which the informed consent is signed by the guardian
Exclusion Criteria:
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The non-satisfaction of the inclusion criteria;
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The diagnosis of epilepsy or serious eye diseases, due to the risk associated with the excessive stimulation of virtual reality
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | P.O. San Giovanni di Dio, AOU Cagliari | Cagliari | Italy | 09100 |
Sponsors and Collaborators
- University of Cagliari
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Prot. PG/2020/7577