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Applied Clinical Trials ; 29(4):12-13, 2020.
Article in English | ProQuest Central | ID: covidwho-20241726


In the short and long term, sponsors should think through: * Protocol modifications to incorporate remote patient and site assessments or other virtual elements. * Patient visit requirements and anticipated data collection challenges. * Effective resumption of activities when the pandemic situation improves. * Improvements to risk management planning.8 * Overall impact on clinical trial and clinical program timelines (including time to approval). [...]each passing day brings new information about the spread of COVID-19 globally. [...]to plan for the short and long term, sponsors should go back to the drawing board and reevaluate overall clinical study design, including patient eligibility, feasibility, enrollment, timelines, and budgets against the evolving global landscape. [...]alarming projections indicate that socialdistancing countermeasures may need to be in place well into 20219, which means that biopharmaceutical sponsors should make urgent decisions now to plan for continued clinical research in the coming months.

Int J Environ Res Public Health ; 19(23)2022 11 25.
Article in English | MEDLINE | ID: covidwho-2123662


While experiencing the unpredictable events of the COVID-19 pandemic, we are likely to turn to people in order to regulate our emotions. In this research, we investigate how this interpersonal emotion regulation is connected to affective symptoms, above and beyond intrapersonal emotion regulation. Furthermore, we explore whether perceived psychosocial resources moderate these associations, i.e., if individuals reporting healthier social connections benefit differently from interpersonal emotion regulation. N = 1401 participants from the USA, UK, Germany, and Switzerland completed an online survey that included text samples. Affective symptoms (depression, adjustment disorder, fear of COVID-19) were examined based on self-reported as well as language-based indicators. As psychosocial resources, we examined social support, loneliness, attachment style, and trust. We defined latent variables for adaptive and maladaptive interpersonal emotion regulation and analyzed how they were associated with affective symptoms controlling for intrapersonal emotion regulation. Further, we analyzed how they interacted with psychosocial resources. Maladaptive interpersonal emotion regulation strategies were associated with affective symptoms. With lower psychosocial resources, the associations between interpersonal emotion regulation and depressive symptoms were more pronounced. The results highlight that maladaptive interpersonal emotion regulation is associated with worse mental health. These effects are not buffered by more psychosocial resources and are stronger for people with low psychosocial resources.

COVID-19 , Emotional Regulation , Humans , Interpersonal Relations , Pandemics , COVID-19/epidemiology , Emotions/physiology