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.

For caregivers in the Bronx, the pandemic has caused unprecedented psychologicaldistress; in addition to combating social determinants of health (SDOH), these familiesnow face greater financial insecurity and challenges related to their school-agedchildren. Furthermore, social distancing requirements and limited telehealth resourcesfor Bronx families have posed greater barriers to healthcare. Such parental distresscontributes to heightened risk of transgenerational cycles of psychological stress,trauma and maltreatment. The social and economic impacts of the COVID-19 pandemic havehad significant consequences for family well-being, putting parents at higher risk ofexperiencing distress and potentially impairing their ability to provide supportive careto their children. Although children may be less susceptible to the most damagingphysical consequences of COVID-19, there are growing concerns regarding the short-andlong-term impacts of pandemic-related stressors on children. The marked upheaval offamily life over an extended period may make children vulnerable to mental healthconsequences associated with the public health crisis and infection mitigation efforts.School and childcare closures, unstable financial circumstances, social isolation andlack of support have a disproportionate, cumulative impact on parents and may underminetheir capacities to provide support for their children. Importantly, a large body ofevidence suggests that parental stress during times of disasters inducespsychopathologies in family members including children. Further, high anxiety anddepressive symptoms in parents during the pandemic have been associated with higher childabuse potential, whereas greater parental support was associated with lower perceivedstress and child abuse potential. In addition to psychological impacts, stress associatedwith caregiving can interfere with parents' ability to maintain their own health. Thismultimodal study addresses key strategies to mitigate the psychological and health impactof COVID-19 in parents.

This study will assess whether the promotion of emotional exchange between mother andinfant during the first four months of life improves primarily mother-child earlyrelational health (ERH) and secondarily child neurodevelopmental and maternal mentalhealth outcomes. In prior research on preterm infants, a similar interventiondemonstrated increased quality of maternal caregiving behaviors and significantimprovements in premature infants' neurodevelopment across multiple domains, includingsocial-relatedness and attention problems. The goal of the emotional exchangeintervention is to help mothers provide appropriate stimulation crucial for social,emotional, and neurobehavioral development, by helping the mother and child becomeattuned, or 'in sync', with each other. Measures of ERH, such as bonding, maternalsensitivity, and mother-child emotional connection will be compared between two groups:one receiving newborn parenting education and the other undergoing facilitated emotionalexchange. Assessments will involve videos of mother-infant interactions during eachintervention session and follow-up surveys conducted as part of a linked InstitutionalReview Board-approved study. Data collected in this study will contribute tounderstanding the underlying mechanisms of mother-infant interactions and their role inshaping optimal neurodevelopmental trajectories for infants and maternal mental health.

Covid-19 is an additional stressor Black women have to deal with that may interfere withhypertension self-care management. Social connectedness is a source of resilience forBlack women to promote mental and physical health. Unfortunately, in the face of theCovid-19 pandemic, social distancing is a challenge further isolating Black women fromtheir networks. How is social connectedness to manage stress and emotional well-being ina social-distancing society for Black women with hypertension? The research team proposeda synchronous web-based version of Enhanced Co-Created Health Education InterventioN(eCo-CHIN) that build the success and best practices derived from the originalintervention. A Covid-19 session will be included as a way of helping Black women tomaintain resilience and self-care during stressful times. The eCo-CHIN intervention isinnovative and timely because the research team are using a synchronous platformpreparing Black women on how to deal with Covid-19 while taking care of self. The primaryinvestigator for this pilot study (Dr. Wright) is a Black Early Stage Investigator andformer KL2 (career development) awardee. The interdisciplinary research team has theexpertise and resources to deliver this Enhanced Co-CHIN intervention.

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.

Aim of the study is to investigate possible predictors and factors that may be associatedwith the development and maintenance of mental and physical health constrains includingdepression and anxiety symptomatology as well as loneliness in hospitalized post-COVIDpatients and non-COVID patients in Germany. Furthermore, it will be investigated whetherpsychological interventions have an effect on anxiety and depression symptomatology, onloneliness values, self-efficacy and perceived social support values. Specifically, theresearch aim is to examine the relationships between loneliness, self-efficacy, andsocial support and to address the question of what factors increase the risk of postcovid depression/anxiety, and to test the buffering effect of physical and socialactivities. For this purpose an experimental group comparison will be applied, in whichtwo interventions will be performed on post-COVID patients and non-COVID patients in theunit of Physical Medicine and Geriatrics in Medical Rehabilitation. (PhD Project byAnnika Roskoschinski, M.Sc., Psychology, Principal Investigator)

It is expected that large numbers of healthcare workers will experience a broad range ofpsychological reactions and symptoms including anxiety, depression, moral distress, andtrauma symptoms that will cause both significant suffering as well as occupational andsocial impairment. The purpose of this study is to find interventions which are helpfulin treating psychological distress in healthcare workers caring for COVID-19 patients.There are two phases of the study. All participants will take part in Phase I, whichconsists of 4 sessions over a two-week period of either a narrative writing interventionor a medical music intervention. Participants will be randomly assigned to the narrativewriting intervention or medical music intervention.After Phase I, participants will be re-assessed. Healthcare workers who meet criteria forPTSD will be given the option to participate in Phase II of the study, in which they willbe offered a choice between one of two evidence-based treatments for PTSD: InterpersonalTherapy (IPT) or Exposure Therapy (ET). Both treatments are comprised of ten 75-minutesessions scheduled twice weekly. Participants will be allowed to choose a preferredtreatment in Phase II. After Phase II participants will complete a final assessmentconcluding the study. All interventions will be offered using distance technology.

The Coronavirus has caused containment of more than a third of the world's population.Containment can drastically change lifestyle habits, including eating habits such as thenumber of meals, meal times or their composition. However, there is currently no data onthe influence of confinement on eating habits.

Coronavirus has caused containment of more than half of the world's population and amajor and rapid reorganization of clinical and support services. The spread ofcoronavirus (COVID-19) has posed significant challenges for occupational health services.However, there is currently no data on the influence of this epidemic on the practice andfeelings of dental surgeons and associates