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.

Assessing the Impact of Conversational Artificial Intelligence in the Treatment of Stress and Anxiety in Aging Adults: Randomized Controlled Trial.

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.