2 Clinical Trials for Various Conditions
During critical personal protective equipment (PPE) shortages, such as those associated with the COVID-19 pandemic, Centers for Disease Control (CDC) recommends N95 extended use (wearing the same N95 for multiple patient encounters) and limited reuse (storing an N95 between shifts for use over multiple shifts with or without decontamination) as contingency and crisis capacity strategies, respectively. Many healthcare workers (HCWs) are employing these strategies out of necessity. The sustained performance of these respirators depends on the respirator maintaining its filtration efficiency and its ability to provide an adequate seal (fit) to the user's face. Fit testing is performed when a respirator is issued to the user and on an annual basis thereafter. A user-seal check is then performed whenever a respirator is donned. Previous studies have found repeated donnings/doffings to significantly decrease the respirator's fit. A recent pilot cross-sectional clinical study conducted by the University of California, San Francisco found fit failures of respirators after being worn for 2 shifts. However, more definitive data regarding respirator performance during reuse and extended use are lacking. The investigators plan to address these critical gaps in knowledge by conducting a prospective cohort study to determine the incidence of N95 fit failure when subjected to extended use/reuse in a clinical setting. The investigators plan to enroll 396 ED providers (including physicians, nurses, and staff) when obtaining a new NIOSH approved N95s and performing serial fit tests at the end of each 8-12 hour shift for up to 5 clinical shifts or until N95 failure, whichever is earlier. By carefully measuring fit test failure in a clinical setting, the investigators will be able to provide guidance regarding the safety of N95 extended use and reuse necessitated by the need for PPE conservation. Specifically, the investigators will address the following research questions: 1) how long N95s maintain their fit during extended use, 2) how many times N95s can be donned/doffed and maintain their fit, 3) the ability of a user seal check to indicate fit in the field, 4) what adverse health effects, reports of discomfort, or symptoms are experienced by users during extended use and reuse, 5) what effect does extended use and reuse have on N95 filtration performance, 6) the level of contamination of N95s when subjected to extended use and reuse, 7) the effect of modifications to N95 (covering an N95 with a face shield or surgical N95s, facial coverings) on fit failure.
This project is an open-label randomized study looking at an 8-week Mindfulness-Based Stress Reduction (MBSR) curriculum vs. an 8-week MBSR curriculum + a group psilocybin-assisted psychotherapy intervention for frontline healthcare providers struggling with symptoms of depression and burnout associated with the SARS-CoV-2 pandemic. Following consenting and enrollment a total of 24 participants will be randomized to receive either an 8-week MBSR curriculum or the same 8-week MBSR curriculum + a group psilocybin-assisted psychotherapy intervention. The group psilocybin-assisted psychotherapy intervention will involve 3 group preparatory sessions (2 hours each), a single 8 hour group psilocybin administration session with a 1:1 therapist to participant ratio (25mg psilocybin dose), and 3 group integration sessions (2 hours each).