An interventional study of Cognitive remedy intervention with virtual reality (CEREBRUM) in Mood Disorders, sponsored by University of Cagliari. Completed at 1 site in Italy. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-03-20.
Sponsored by University of Cagliari · Not applicable, Interventional, and Treatment
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
584 studies on the registry are indexed under Mood Disorders; 117 are open to participants now.
This study's enrollment of 50 is below the median of 72 across 429 interventional studies indexed under Mood Disorders.
Browse Mood Disorders studies →University of Cagliari is the lead sponsor of 82 studies on the registry; 17 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 1 (20%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The experimental group A receives the cognitive remedy intervention with virtual reality (CEREBRUM)
Device: Cognitive remedy intervention with virtual reality (CEREBRUM)
waiting list
Device: Cognitive remedy intervention with virtual reality (CEREBRUM)
Cognitive Remedial method Virtual Reality (CEREBRUM)
Memory
Rey's Figure Test Word's Figure Test Digit Span Forward and Backward Test Test of the Tale
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)
Monitoring Side effects of Virtual Reality
Questionnaire (Qualitative)
Time frame: During the first VR session - At 1 month (after 8 sessions) - T1 (at 3 months from baseline)
Attention
Matrix Test Digit Symbol Substitution Test
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)
Executive functions
Trial Making Test Verbal Phonological and Semantic Fluency Test Cognitive Estimation Test - CET Stroop Test Frontal Assessment Battery - FAB
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)
Quality of Life
Short Form Healthy Survey Questionnaire - SF-12
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
Toronto Alexithymia Scale - TAS-20
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
Self Anxiety Rating Scale - SAS
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
The Patient Health Questionnaire - PHQ-9
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
Biological Rythms Interview of Assesment in Neuropsychiatry - BRIAN
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
Health of the Nation Outcome Scales - HoNOS
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)
Plan to share: No
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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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University of Cagliari