COVID-19 Clinical Trials and Expanded Access

This randomized controlled trial will evaluate the implementation and(cost-)effectiveness of the culturally and contextually adapted Doing What Matters intimes of stress (DWM) and Problem Management Plus (PM+) stepped-care programs amongstasylum seekers, refugees, and/or migrants living in Italy. Outcomes include mentalhealth, resilience, wellbeing, health inequalities, and costs to health systems.

Stress is underpinned by a biological reaction of the organism allowing the production ofenergy to respond to a change in the environment (or stressor). Stress reaction isexpressed in behavioural, cognitive, emotional and physiological terms. This biologicalresponse is non-specific because it is the same regardless of the stressor. Its evolutionover time has been conceptualised by Hans Selye (1956) in the General Adaptation Syndrome(GAS) which comprises three successive phases. (i) The first phase, known as the alarmphase, corresponds to the activation of all biological mechanisms according to a trendregulation, allowing a rapid response to the stressor. (ii) The second phase ofresistance which adjusts the stress response to the intensity of the perceived aggressionaccording to a constant regulation. (iii) When the aggression disappears, a recoveryphase dominated by the return of the parasympathetic brake allows a return to homeostasis(eustress).The "primum movens" of all pathologies is therefore the inability of the individual toadapt his stress response in duration and/or intensity to the course of the phases of theGAS (distress). The perception of not being in control of the situation contributes tothe perceived stress and constitutes a well-established risk of distress. It is a riskfactor for the emergence of burnout. It induces a biological cost called allostatic cost.Allostasis is a concept that characterizes the process of restoring homeostasis in thepresence of a physiological challenge. The term "allostasis" means "achieving stabilitythrough change", and refers in part to the process of increasing sympathetic activity andcorticotropic axis to promote adaptation and restore homeostasis. Allostasis works wellwhen allostasis systems are initiated when needed and turned off when they are no longerrequired. Restoring homeostasis involves effective functioning of the parasympatheticsystem. However, when the allostasis systems remain active, such as during chronicstress, they can cause tissue burnout and accelerate pathophysiological processes.The perception of uncontrollability depends on the stress situation, the psychologicaland physiological characteristics of the subject and his or her technical skills inresponding to the stressors of the situation. In particular, subjects with a high levelof mindfulness are more accepting of uncontrollability and less likely to activate thestress response.The COVID-19 pandemic situation is a situation characterized by many uncertainties aboutthe individual, family and work environment and the risk of COVID infection. Healthcareworkers, like the military, are high-risk occupations that are particularly exposed tothese uncertainties in the course of their work and continue to work in an uncertainsituation. These professionals are described as a population at risk ofoccupational/operational burnout that the level of burnout operationalises. Thisancillary study in a population of civilian and military non-healthcare workers willcomplement the study conducted among military health care workers. It will make itpossible to isolate the specificity of each profession (civilian or military, healthcarepersonnel or not) with regard to the risk of burnout in the COVID context.The objective of this project is to evaluate the impact of the perception of non-controlin the operational burnout of experts in their field of practice and to study thepsychological and physiological mechanisms mediating the relationship between thesubject's characteristics, perceived non-control and burnout.

The coronavirus (COVID-19) pandemic is a significant psychological stressor thatthreatens the onset of a mental health crisis in the US. Fear and anxiety about COVID-19and its economic impact, as well as loneliness due to the required social isolation, aredriving the mental health impacts of COVID-19; in a recent Kaiser Family Foundation poll,45% of respondents reported that the coronavirus has had a negative impact on theirmental health. This is reflected in Southeastern Ohio. In data that the investigatorscollected from 317 Ohio University faculty, staff, and students from late May to earlyJune, 39% reported moderate-to-severe levels of anxiety, 41% reported moderate-to-severelevels of depression and 57% reported the COVID-19 outbreak was impacting their sense ofsocial connection much or very much. Despite the significant community need foraccessible and affordable care, there are currently no evidence-based interventions forindividuals coping poorly with coronavirus-related distress. The investigators havedeveloped a virtual group-based intervention targeting cognitive biases that amplify theexperience of stress and anxiety (i.e., amplifying cognitions; Coping withCoronavirus-Related Emotion and Worry [COPING CREW]). The next step in developing thisintervention in a scientifically rigorous manner is to refine the manual and proceduresand conduct a pilot test of the intervention.

The purpose of this study is to examine how patients with multiple myeloma (MM) have beenimpacted by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic.The study will use a questionnaire to further understand how patients are being affectedand gather information in order to track the long-term effects of the coronavirus.The scope of the questionnaire will include, COVID-19 diagnosis and treatment, changes inmyeloma treatment and care, clinical trial familiarity, health and fitness, and qualityof life.This questionnaire is a follow-on to the "MM and COVID-19" questionnaire.

Since the 1960s, studies have shown that oral polio vaccine (OPV) may have beneficialnon-specific effects, reducing morbidity and mortality from other infections than polio.Such beneficial non-specific effect have been observed for other live vaccines, includingmeasles, smallpox and BCG vaccine. For BCG, the vaccine for which the mechanism has beenstudied the most, the effects appear to be mediated through the innate immune system. TheCOVID-19 pandemic caused by the novel coronavirus SARS-CoV-2 has now caused over 7.1million cases and >400,000 deaths worldwide. As everywhere else, it is anticipated thatin Africa the older part of the population will be at risk of severe COVID-19. OPV iswidely used in Africa, but for children. Both polio and coronavirus are positive-strandRNA viruses, therefore it is likely that they may induce and be affected by common innateimmune mechanisms.In a randomised trial at the Bandim Health Project in Guinea-Bissau, the investigatorswill assess the effect of providing OPV vs no vaccine to 3400 persons above 50 years ofage. The trial will have the power to test the hypothesis that OPV reduces the combinedrisk of morbidity admission or death (composite outcome) by at least 28% over thesubsequent 6 months.

COVID19 patients survivors, after discharge from hospital show reduced lung function andreduced ability to exercise. Furthermore, mental health problems including stress,anxiety and depression and a low quality of life were observed. The prospectiveobservational study involves COVID19 patients who have needed rehabilitation at theUniversity Hospital of Ferrara. Patients receive comprehensive rehabilitation based ontheir specific needs in both acute and subacute rehabilitation. At the end of hospitalrehabilitation, patients are offered a program to be carried out at home for bothphysical and psychological problems. A range of demographic and clinical data will becollected. Patients will also undergo a battery of functional, cognitive andpsychological tests at 12, 26 and 52 weeks from the infection onset. Moreover, a specificassessement (both clinical and instrumental) on the pain symptom experienced, wherepresent, will be done.

The purpose of this study is to describe post-intensive care syndrome (PICS) of patientssurviving to coronavirus disease 2019 (COVID19) and their rehabilitation and recoveryprocess from hospital to home return

Coronavirus disease 2019 (COVID-19) and associated emergency measures (EM) havedramatically impacted the lives of children/adolescents (children) and families. Theclosure of schools, social and recreational activities, and modifications to workenvironments has led to significant changes in the way children and families are working,living and socializing. Although the impact on the mental health of children and familieshas not been well researched, it is anticipated that already stressed children andfamilies with pre-COVID-19 mental health challenges are at significant risk fordeterioration in their mental health. As such, the implementation, and evaluation(specifically: feasibility, acceptability and barriers) of virtual-care interventions toalleviate child and family anxiety and enhance family functioning are critical.Virtual-care also optimizes health equity initiatives in reducing social, economic andenvironmental barriers to services that can improve or maintain mental health (WHO, 2017;MOHLTC, 2018).The current study will evaluate an adapted virtual-care cognitive behavioural therapy(CBT) program for children with anxiety (VC-CBT). CBT has a strong evidence-base intreating children with anxiety disorders (Higa-McMillan, Francis, Rith-Najarian, andChorpita, 2016; Seligman and Ollendick, 2011), with increasing evidence supporting theefficacy of virtual-care CBT for childhood anxiety disorders (Carpenter, Pincus, Furr,and Comer, 2018; Slone, Reese, and McClellan, 2012). This study aims to evaluate thefeasibility, participation barriers related to social determinants of health (SDH) andacceptability of this virtual-care intervention in addressing mental health challengesassociated with the COVID-19 pandemic and ensuing EM in the immediate time-period. Earlyevaluation of this virtual-care intervention will enable future scale-up of thisintervention during the post-pandemic recovery time-period and during subsequent COVID-19waves, if necessary.

The Harnessing Online Peer Education COVID-19 (HOPE COVID-19) intervention will assesswhether a peer-led online support community can improve behavioral health outcomesrelated to COVID-19.

Mental health disorders are common during pregnancy and the postnatal period, and canhave serious adverse effects on the well-being of woman and child. Every tenth woman hasdepressive symptoms and 5% suffer major depression during pregnancy. The consequences forglobal mental health due to the novel coronavirus disease, COVID-19, are likely to besignificant and may have long-term impact on the global burden of disease. Pregnant womenmay be particularly vulnerable due to partial immune suppression. Besides physicalvulnerability, the women could be at increased risk of mental health problems, such asanxiety, depression, and post-traumatic stress disorder (PTSD), due to social distancingleading to less support from the family and friends, and in some cases, partners notbeing allowed to be present during prenatal visits, labor and delivery. Furthermore, manypregnant women may feel insecure and worried about the effect of COVID-19 on their unbornchild, if the women get infected during pregnancy. Today, young urban women are used toutilizing internet services frequently and efficiently. Therefore, providing mentalhealth support to pregnant women via web-based support may be effective in amelioratingtheir anxiety/depression and reduce the risk of serious mental health disorders leadingto improved maternal and perinatal outcomes.