Virtual Reality VAlidation Tool for Cognitive Rehabilitation, Oriented Project for People With Psychosocial Disabilieties
NCT ID: NCT05070065
Last Updated: 2023-03-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2021-11-10
2022-02-10
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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virtual reality
The experimental group A receives the cognitive remedy intervention with virtual reality (CEREBRUM)
Cognitive remedy intervention with virtual reality (CEREBRUM)
Cognitive Remedial method Virtual Reality (CEREBRUM)
waiting list
waiting list
Cognitive remedy intervention with virtual reality (CEREBRUM)
Cognitive Remedial method Virtual Reality (CEREBRUM)
Interventions
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Cognitive remedy intervention with virtual reality (CEREBRUM)
Cognitive Remedial method Virtual Reality (CEREBRUM)
Eligibility Criteria
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Inclusion Criteria
* 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
* The diagnosis of epilepsy or serious eye diseases, due to the risk associated with the excessive stimulation of virtual reality
18 Years
75 Years
ALL
No
Sponsors
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University of Cagliari
OTHER
Responsible Party
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Mauro Giovanni Carta
Professor
Locations
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P.O. San Giovanni di Dio, AOU Cagliari
Cagliari, , Italy
Countries
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References
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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.
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.
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.
Other Identifiers
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Prot. PG/2020/7577
Identifier Type: -
Identifier Source: org_study_id
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