Cognitive Remediation Virtual Reality Tool a Recovery-Oriented Project for People with Bipolar Disorder: Protocol of a Feasibility Randomized Clinical Trial
Alessandra Perra1, 3, *, Valerio De Lorenzo2, Rosanna Zaccheddu3, Aurora Locci3, Federica Piludu3, Antonio Preti4, Lorenzo Di Natale5, Alessia Galetti3, Antonio Egidio Nardi6, Giulia Cossu3, Federica Sancassiani3, Simone Barbato5, Ottavio Cesaretti2, Peter Konstantin Kurotshka3, 7, Mauro G. Carta3
Identifiers and Pagination:Year: 2022
E-location ID: e174501792208220
Publisher ID: e174501792208220
Article History:Received Date: 31/3/2022
Revision Received Date: 27/6/2022
Acceptance Date: 15/7/2022
Electronic publication date: 06/10/2022
Collection year: 2022
open-access license: This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 International Public License (CC-BY 4.0), a copy of which is available at: https://creativecommons.org/licenses/by/4.0/legalcode. This license permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Cognitive deficits are considered a fundamental component of bipolar disorder due to the fact that they negatively impact personal/social functioning. Cognitive remediation interventions are effective in the treatment of various psychosocial disorders, including bipolar disorder. The use of Virtual reality as a rehabilitation tool has produced scientific evidence in recent years, especially in cardiovascular, neurological, and musculoskeletal rehabilitation. This study aims at evaluating the feasibility of a Cognitive Remediation Virtual Reality Program (CEREBRUM) for people with bipolar disorder in psychiatric rehabilitation.
Material and Methods:
Feasibility randomized controlled cross-over clinical study; we randomized 50 people from the Consultation and Psychosomatic Psychiatry Center of the University Hospital of Cagliari (San Giovanni di Dio Civil Hospital) with a diagnosis of bipolar disorder. We propose a cognitive remediation program in virtual reality (CEREBRUM), 3 months with 2 weekly sessions, for the experimental group and a usual care program for the control group (psychiatric visit and/or psychotherapy).
The results of the trial will be published in international peer-reviewed journals and will be disseminated at international meetings and congress.
This RCT aims, with regards to its feasibility and design, to provide information about a confirmatory trial that evaluates the effectiveness of a Virtual Reality Cognitive Remediation program in psychiatric rehabilitation for the treatment of cognitive dysfunction in people with bipolar disorder.
The results that we analyzed at the end of the RCT will have an impact on psychiatric rehabilitation research with a focus on improving the application of technologies for mental health.
Trial registration: ClinicalTrialsgov NCT05070065, registered on September 2021.