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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

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

Conditions
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Mood Disorders

Intervention / Treatment
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* Device: Cognitive remedy intervention with virtual reality (CEREBRUM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized controlled open-label cross-over clinical feasibility study with waiting list
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: virtual reality<br>The experimental group A receives the cognitive remedy intervention with virtual reality (CEREBRUM) | Device: Cognitive remedy intervention with virtual reality (CEREBRUM)<br>* Cognitive Remedial method Virtual Reality (CEREBRUM)<br>|
| Other: waiting list<br>waiting list | Device: Cognitive remedy intervention with virtual reality (CEREBRUM)<br>* Cognitive Remedial method Virtual Reality (CEREBRUM)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Virtual Reality, Remediation, Mental Health, Recovery