TY - JOUR A1 - Perra, Alessandra A1 - Galetti, Alessia A1 - Zaccheddu, Rosanna A1 - Locci, Aurora A1 - Piludu, Federica A1 - Preti, Antonio A1 - Primavera, Diego A1 - Di Natale, Lorenzo A1 - Nardi, Antonio Egidio A1 - Kurotshka, Peter Konstantin A1 - Cossu, Giulia A1 - Sancassiani, Federica A1 - Stella, Giusy A1 - De Lorenzo, Valerio A1 - Zreik, Thurayya A1 - Carta, Mauro Giovanni T1 - A recovery-oriented program for people with bipolar disorder through virtual reality-based Cognitive Remediation: results of a feasibility randomized clinical trial JF - Journal of Clinical Medicine N2 - Background: Cognitive impairment is a frequent consequence of bipolar disorder (BD) that is difficult to prevent and treat. In addition, the quality of the preliminary evidence on the treatment of BD through Cognitive Remediation (CR) with traditional methods is poor. This study aims to evaluate the feasibility of a CR intervention with fully immersive Virtual Reality (VR) as an additional treatment for BD and offers preliminary data on its efficacy. Methods: Feasibility randomized controlled cross-over clinical study, with experimental condition lasting three months, crossed between two groups. Experimental condition: CR fully immersive VR recovery-oriented program plus conventional care; Control condition: conventional care. The control group began the experimental condition after a three months period of conventional care (waiting list). After the randomization of 50 people with BD diagnosis, the final sample consists of 39 participants in the experimental condition and 25 in the control condition because of dropouts. Results: Acceptability and tolerability of the intervention were good. Compared to the waitlist group, the experimental group reported a significant improvement regarding cognitive functions (memory: p = 0.003; attention: p = 0.002, verbal fluency: p = 0.010, executive function: p = 0.003), depressive symptoms (p = 0.030), emotional awareness (p = 0.007) and biological rhythms (p = 0.029). Conclusions: The results are preliminary and cannot be considered exhaustive due to the small sample size. However, the evidence of efficacy, together with the good acceptability of the intervention, is of interest. These results suggest the need to conduct studies with larger samples that can confirm this data. Trial registration: ClinicalTrialsgov NCT05070065, registered in September 2021 KW - virtual reality KW - Cognitive Remediation KW - mental health KW - recovery Y1 - 2023 U6 - http://nbn-resolving.de/urn/resolver.pl?urn:nbn:de:bvb:20-opus-311201 SN - 2077-0383 VL - 12 IS - 6 ER -