BACKGROUND While mental health applications are increasingly available for large populations of users, there is a lack of controlled trials on the impact of such applications. An important population segment includes the senior adults. AI-empowered agents are evaluated when assisting adults with cognitive impairments, while few applications are available for aging adults who are still in their active working life. Those persons often suffer from high levels of stress related to changes in their working places, and the stress related symptoms eventually affect their quality of life. OBJECTIVE Evaluate the contribution of TEO (Therapy Empowerment Opportunity), an m-health agent based on conversational AI technology. TEO promotes mental health and wellbeing by reducing work related stress symptoms and anxiety levels in aging subjects. METHODS The study is based on a protocolized intervention for stress and anxiety management where patients with stress symptoms and mild-to-moderate levels of anxiety received eight-weeks CBT treatment delivered remotely. A group of participants also interacted with an m-health agent. Based on deep learning methodology, the agent assisted them in completing the therapy assignments, and engaged them in conversations where they were helped to explain the details of events that increased their anxiety. The participants were active workers aged over 55. Four experimental groups were selected. Group1 received traditional therapy while Group2 also conversed with the m-health agent. Group3 received support only by the m-health application, and Group4 did not receive any treatment. The symptoms related to stress (levels of anxiety, physical disease, and depression) were assessed prior to the treatment (T1), at the end (T2), and three months after (T3) by submitting standardized psychological questionnaires. At T2 participants in Groups 1, 2 and 3 filled in a satisfaction questionnaire. RESULTS Despite the randomization of the sample, at T1 statistically significant differences between groups were present: G4 showed lower levels of anxiety and depression compared to G1, and lower levels of stress compared to G2. Comparisons between groups at T2 and T3 did not show significant differences in outcomes. Analyses conducted within groups showed that there are significant differences between times in Group 2, for which greater improvements were found on the levels of stress and scales related to overall well-being. A general worsening trend between T2 and T3 can be detected in all groups, showing a significant increase in the levels of stress in G2. As for the satisfaction questionnaire, Group 2 reported higher levels of perceived usefulness and satisfaction. CONCLUSIONS In general, the study results showed that participants who received traditional CBT treatment with the support of the m-health application were likely to report better satisfaction and more stable trend of improvement limited to the individual perception of stress related symptoms. CLINICALTRIAL ClinicalTrials.gov Identifier: NCT04809090 INTERNATIONAL REGISTERED REPORT RR2-10.2196/30053

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.

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.

Background While mental health applications are increasingly becoming available for large populations of users, there is a lack of controlled trials on the impacts of such applications. Artificial intelligence (AI)-empowered agents have been evaluated when assisting adults with cognitive impairments; however, few applications are available for aging adults who are still actively working. These adults often have high stress levels related to changes in their work places, and related symptoms eventually affect their quality of life. Objective We aimed to evaluate the contribution of TEO (Therapy Empowerment Opportunity), a mobile personal health care agent with conversational AI. TEO promotes mental health and well-being by engaging patients in conversations to recollect the details of events that increased their anxiety and by providing therapeutic exercises and suggestions. Methods The study was based on a protocolized intervention for stress and anxiety management. Participants with stress symptoms and mild-to-moderate anxiety received an 8-week cognitive behavioral therapy (CBT) intervention delivered remotely. A group of participants also interacted with the agent TEO. The participants were active workers aged over 55 years. The experimental groups were as follows: group 1, traditional therapy; group 2, traditional therapy and mobile health (mHealth) agent; group 3, mHealth agent; and group 4, no treatment (assigned to a waiting list). Symptoms related to stress (anxiety, physical disease, and depression) were assessed prior to treatment (T1), at the end (T2), and 3 months after treatment (T3), using standardized psychological questionnaires. Moreover, the Patient Health Questionnaire-8 and General Anxiety Disorders-7 scales were administered before the intervention (T1), at mid-term (T2), at the end of the intervention (T3), and after 3 months (T4). At the end of the intervention, participants in groups 1, 2, and 3 filled in a satisfaction questionnaire. Results Despite randomization, statistically significant differences between groups were present at T1. Group 4 showed lower levels of anxiety and depression compared with group 1, and lower levels of stress compared with group 2. Comparisons between groups at T2 and T3 did not show significant differences in outcomes. Analyses conducted within groups showed significant differences between times in group 2, with greater improvements in the levels of stress and scores related to overall well-being. A general worsening trend between T2 and T3 was detected in all groups, with a significant increase in stress levels in group 2. Group 2 reported higher levels of perceived usefulness and satisfaction. Conclusions No statistically significant differences could be observed between participants who used the mHealth app alone or within the traditional CBT setting. However, the results indicated significant differences within the groups that received treatment and a stable tendency toward improvement, which was limited to individual perceptions of stress-related symptoms. Trial Registration ClinicalTrials.gov NCT04809090; https://clinicaltrials.gov/ct2/show/NCT04809090

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