Safety and efficacy of repetitive stimulation of the left dorsolateral prefrontal cortex using transcranial focused ultrasound in treatment-resistant depressed patients: A non-inferiority randomized controlled trial protocol.

BACKGROUND: About 30% of patients diagnosed with major depressive disorder fail with the mainstream pharmacological treatment. Patients who do not achieve clinical remission of symptoms, even with two different antidepressants, are classified with treatment-resistant depression (TDR). This condition imposes an additional burden with increased Disability Adjusted Life Years. Therefore, complementary treatments, such as neuromodulation, are necessary. The transcranial focused ultrasound (tFUS) has emerged in the past few years as a reliable method for non-invasive neuromodulation in humans and may help treat TRD. This study aims to propose a research protocol for a non-inferiority randomized clinical trial of TDR with tFUS. METHODS: Patients with documented TRD will be screened upon entering the TRD outpatient clinic at UFMG (Brazil). One hundred patients without a clinical history of other psychiatric illness, anatomical abnormalities on magnetic resonance imaging (MRI), or treatment with electroconvulsive therapy will be invited to participate. Patients will be randomized (1:1) into two groups: 1) treatment with a previously established protocol of transcranial magnetic stimulation; and 2) treatment with a similar protocol using the stimulation. Besides regular consultations in the outpatient clinic, both groups will attend 7 protocolled spaced days of brain stimulation targeted at the left dorsolateral prefrontal cortex. They will also be submitted to 4 sessions of image studies (2 MRIs, 2 positron-emission tomography), 3 of neuropsychological assessments (at baseline, 1 week and 2 months after treatment), the Montgomery-Åsberg Depression Rating Scale to analyze the severity of depressive symptoms. DISCUSSION: This clinical trial intends to verify the safety and clinical efficacy of tFUS stimulation of the dorsolateral prefrontal cortex of patients with TRD, compared with a previously established neuromodulation method.

Impacts of mental health in the sleep pattern of healthcare professionals during the COVID-19 pandemic in Brazil.

BACKGROUND: After >2 years of the Coronavirus Disease-19 (COVID-19) pandemic, it is well established how sleep symptoms are rising, especially among healthcare workers (HCW). The aim of this study is to evaluate what features are associated with sleep disturbances in the HCW population. METHODS: Cross-sectional and longitudinal analysis of social and clinical variables associated with sleep problems and insomnia incidence in HCW in a large, national-level cohort. The measurement of sleep problems was assessed by self-report using Jenkins Sleep Scale (JSS). A multivariate analysis was used in the cross-sectional design and generalized linear models were used in the longitudinal design. RESULTS: 10,467 HCW were analyzed in the cross-sectional analysis, 3313 participants were analyzed in the three timepoints of the study. Sex, previously diagnosed mental illness and frontline work with COVID-19 were associated with higher scores in JSS in the univariate analysis. In the multivariate analysis, only previous diagnosis of mental illness was related with sleep difficulties, especially previously diagnosed insomnia. The longitudinal analysis concluded that previous diagnosis of mental illnesses was associated with higher levels of insomnia development (OR = 11.62). The self-reported disorders found to be major risk factors were addiction (OR = 7.69), generalized anxiety disorder (OR = 3.67), social anxiety (OR = 2.21) and bipolar disorder (OR = 2.21). LIMITATIONS: Attrition bias. CONCLUSIONS: Previous diagnosis of mental illness was strongly related to insomnia development in HCW during the COVID-19 pandemic. Strategies that focus on this population are advised.