Cognitive Remediation Virtual Reality Tool a Recovery-Oriented Project for People with Bipolar Disorder: Protocol of a Feasibility Randomized Clinical Trial.

Introduction: 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). Results: The results of the trial will be published in international peer-reviewed journals and will be disseminated at international meetings and congress. Discussion: 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. Conclusion: 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.

Quality of information of websites dedicated to obesity: a systematic search to promote high level of information for Internet users and professionals.

BACKGROUND: The Internet is increasingly used as a source of information. This study investigates with a multidimensional methodology the quality of information of websites dedicated to obesity treatment and weight-loss interventions. We compared websites in English, a language that it is used for the international scientific divulgation, and in Italian, a popular local language. METHODS: Level of Evidence: Level I, systematic review search on four largely used search engines. Duplicated and unrelated websites were excluded. We checked: popularity with PageRank; technological quality with Nibbler; readability with the Flesch Reading Ease test or the Gulpease readability index; quality of information with the DISCERN scale, the JAMA benchmark criteria, and the adherence to the Health on the Net Code. RESULTS: 63 Italian websites and 41 English websites were evaluated. English websites invested more in the technological quality especially for the marketing, experience of the user, and mobile accessibility. Both the Italian and English websites were of poor quality and readability. CONCLUSIONS: These results can inform guidelines for the improvement of health information and help Internet users to achieve a higher level of information. Users must find benefits of treatment, support to the shared decision-making, the sources used, the medical editor's supervision, and the risk of postponing the treatment.

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.

Background: Alexithymia, a predictor in chronic illnesses, like cardiovascular and bipolar disorder (CD-BD), could be improved with a virtual reality (VR) cognitive remediation program. This secondary analysis of a previous randomized controlled trial (RCT) evaluates alexithymia improvement and its factors in an experimental group versus a control group, exploring extensions to individuals with comorbid non-psychiatric chronic conditions. Methods: A feasibility cross-over RCT (ClinicalTrials.gov NCT05070065) enrolled individuals aged 18-75 with mood disorders (BD, DSM-IV), excluding those with relapses, epilepsy, or severe eye conditions due to potential risks with VR. Alexithymia levels were measured using the Toronto Alexithymia Scale with 20 items (TAS-20). Results: The study included 39 individuals in the experimental group and 25 in the control group, with no significant age or sex differences observed. Significantly improved alexithymia scores were noted in the experimental group compared to controls (F = 111.9; p < 0.0001) and in subgroups with chronic non-psychiatric comorbidities (F = 4.293, p = 0.048). Scores were particularly improved for difficulty in identifying feelings (F = 92.42; p < 0.00001), communicating feelings (F = 61.34; p < 0.00001), and externally oriented thinking (F = 173.12; p < 0.00001). Conclusions: The findings highlight alexithymia enhancement in BD, even with comorbid non-psychiatric chronic diseases. Given its impact on BD progression and related conditions, like CD, developing and evaluating VR-based tools in this context is suggested by these findings.

Improving Social and Personal Rhythm Dysregulation in Young and Old Adults with Bipolar Disorder: Post-Hoc Analysis of a Feasibility Randomized Controlled Trial Using Virtual Reality-Based Intervention.

Introduction: Rehabilitative interventions employing technology play a crucial role in bipolar disorder (BD) treatment. The study aims to appraise the virtual reality (VR)-based cognitive remediation (CR) and the interpersonal rhythm approaches to treatment outcomes of BD across different age groups. Methods: Post-hoc analysis of a 12-week randomizedcontrolled cross-over feasibility trial involving people with mood disorders (BD, DSM-IV) aged 18-75 years old: thirty-nine exposed to the experimental VR-based CR vs 25 waiting list controls. People with BD relapse, epilepsy or severe eye diseases (due to the potential VR risks exposure) were excluded. Biological Rhythms Interview of Assessment in Neuropsychiatry (BRIAN) was used to measure the outcome. Results: Cases and controls did not statistically significantly differ in age and sex distributions. Personal rhythm scores improved over the study follow-up in the experimental vs the control group (APC = 8.7%; F = 111.9; p < 0.0001), both in young (18-45 years) (APC = 5.5%; F = 70.46; p < 0.0001) and, to a lesser extent, older (>46 years) adults (APC = 10.5%; F = 12.110; p = 0.002). Conclusions: This study observed improved synchronization of personal and social rhythms in individuals with BD after a virtual reality cognitive remediation intervention, particularly in social activity, daily activities, and chronotype, with greater benefits in the younger population.

Fully Immersive Virtual Reality-Based Cognitive Remediation for Adults with Psychosocial Disabilities: A Systematic Scoping Review of Methods Intervention Gaps and Meta-Analysis of Published Effectiveness Studies.

BACKGROUND: Cognitive Remediation (CR) programs are effective for the treatment of mental diseases; in recent years, Virtual Reality (VR) rehabilitation tools are increasingly used. This study aimed to systematically review and meta-analyze the published randomized controlled trials that used fully immersive VR tools for CR programs in psychiatric rehabilitation. We also wanted to map currently published CR/VR interventions, their methods components, and their evidence base, including the framework of the development intervention of CR in fully immersive VR. METHODS: Level 1 of evidence. This study followed the PRISMA extension for Scoping Reviews and Systematic Review. Three electronic databases (Pubmed, Cochrane Library, Embase) were systematically searched, and studies were included if they met the eligibility criteria: only randomized clinical trials, only studies with fully immersive VR, and only CR for the adult population with mental disorders. RESULTS: We found 4905 (database) plus 7 (manual/citation searching articles) eligible studies. According to inclusion criteria, 11 studies were finally reviewed. Of these, nine included patients with mild cognitive impairment, one with schizophrenia, and one with mild dementia. Most studies used an ecological scenario, with improvement across all cognitive domains. Although eight studies showed significant efficacy of CR/VR, the interventions' development was poorly described, and few details were given on the interventions' components. CONCLUSIONS: Although CR/VR seems to be effective in clinical and feasibility outcomes, the interventions and their components are not clearly described. This limits the understanding of the effectiveness and undermines their real-world implementation and the establishment of a gold standard for fully immersive VR/CR.

A Recovery-Oriented Program for People with Bipolar Disorder through Virtual Reality-Based Cognitive Remediation: Results of a Feasibility Randomized Clinical Trial.

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.