Influence on study outcomes of an inpatient study by the behavior of the study staff (PINgPOng): study protocol for a randomized clinical trial.

BACKGROUND: The placebo effect as the symptom improvement following inert treatments is a fixed component of RCTs to differentiate between specific effects of the tested pharmacological substance from other unspecific effects. The PINgPOng study was set up to analyze the influence of a study team trained to either minimize the placebo response and optimize drug-placebo differences or to maximize the placebo response to increase drug efficacy by unspecific factors on the study results of a RCT in a classical early clinical trial setting. METHODS/DESIGN: PINgPOng is a single-center, prospective, randomized, double-blind, placebo-controlled study in a 3-group, 2-sequence, 2-period cross-over design. The study is conducted according to the principles of ICH-GCP and the Declaration of Helsinki on the Phase I-Unit of the University Hospital Bonn. The primary endpoint is the pain intensity in the cold pressor test before and after the administration of 15 mg oxycodone or placebo. The pain intensity is compared between three study conditions: 32 healthy volunteers in each study arm will be treated either by an untrained study team (arm A), by a study team trained to maximize (arm B), or to minimize placebo responses (arm C). Neuroendocrine factors (alpha-amylase activity, salivary cortisol), characteristic traits (anxiety, depression, stress), and somatic reactions are analyzed as covariates of the pain perception. DISCUSSION: The PINgPOng study will allow to answer the question whether and to what extent the behavior of a trained study team (neutral vs. maximize vs. minimize placebo responses) will differentially affect placebo responses in a setting of a highly standardized early clinical trial. The results will help to control the placebo effects by education of the clinical study team and to avoid unnecessary high placebo effects in clinical development. TRIAL REGISTRATION: German Clinical Trials Register DRKS00013586 . Registered on December 22, 2017.

A brief screening tool for depression in psoriasis patients: The Two Questions Test in clinical practice.

Patients suffering from chronic inflammatory diseases such as psoriasis are prone to develop depressive symptoms. However, within the time constraints of dermatological clinics, depressive symptoms in psoriasis patients are often overlooked and thus underdiagnosed. The Two Questions Test may serve as a quick screening tool for an initial assessment of depressive burden in these patients. We evaluated its usefulness in the clinical context analyzing the records of patients starting systemic treatment for psoriasis with a selective interleukin (IL)23- or IL17A-inhibitor. In a total sample of N = 139 patients, baseline Two Questions Test scores were analyzed together with measures of psoriatic and psychiatric symptoms. In addition, the development of the Two Questions Test scores over the course of the first 28 weeks of treatment was assessed. No association was found between the Two Questions Test scores and skin symptoms measured by the Psoriasis Area and Severity Index and the visibility of skin lesions. However, skin related quality of life analyzed with the Dermatology Life Quality Index was associated with the Two Questions Test scores. In addition, the longitudinal analysis revealed improvement in Two Questions Test outcomes over the course of patients' treatment. These results indicate the Two Questions Test's usefulness both as an initial screening tool of depressive symptoms, as well as in its use as a sensitive tool for the repeated assessment of depressive symptoms in psoriasis patients.

To stress or not to stress: Brain-behavior-immune interaction may weaken or promote the immune response to SARS-CoV-2.

The COVID-19 pandemic continues to strongly affect people with health disadvantages, creating a heavy burden on medical systems and societies worldwide. Research is growing rapidly and recently revealed that stress-related factors such as socio-economic status, may also play a pivotal role. However, stress research investigating the underlying psychoneuroimmune interactions is missing. Here we address the question whether stress-associated neuroendocrine-immune mechanisms can possibly contribute to an increase in SARS-CoV-2 infections and influence the course of COVID-19 disease. Additionally, we discuss that not all forms of stress (e.g. acute versus chronic) are detrimental and that some types of stress could attenuate infection-risk and -progression. The overall aim of this review is to motivate future research efforts to clarify whether psychosocial interventions have the potential to optimize neuroendocrine-immune responses against respiratory viral infections during and beyond the COVID-19 pandemic. The current state of research on different types of stress is summarized in a comprehensive narrative review to promote a psychoneuroimmune understanding of how stress and its mediators cortisol, (nor)adrenaline, neuropeptides and neurotrophins can shape the immune defense against viral diseases. Based on this understanding, we describe how people with high psychosocial stress can be identified, which behaviors and psychosocial interventions may contribute to optimal stress management, and how psychoneuroimmune knowledge can be used to improve adequate care for COVID-19 and other patients with viral infections.

[Can Stress Interact with SARS-CoV-2? A Narrative Review with a Focus on Stress-Reducing Interventions that may Improve Defence against COVID-19]. / Stress und Covid-19: Ein Narrativer Review über neuroendokrin-immune Mechanismen, die eine Abwehr von SARS-CoV-2 verbessern könnten.

OBJECTIVE: The COVID-19 pandemic is on the rise and causes many concerns and fears in the population as well as among medical care givers. This raises the question as to how psychosocial stress associated with the pandemic can be managed, and also if certain forms of stress can contribute to an increase in infections and critical illnesses. METHODS: Against the background of the current state of research on stress and the immune response, we provide a narrative review of studies addressing the question as to how stress can influence the immune defence against viral diseases. RESULTS: Excessive stress can compromise the barrier function of the airways and alter neuroendocrine control of immune function, which can create a virus-permissive immune response. DISCUSSION: Because certain forms of stress can play a role in the successful immune defence against viral respiratory disease, it is important to identify people with high psychosocial stress and to help them manage their stress. Conclusion Psychosocial measures that contribute to improved stress management may have a positive effect on the immune response against viral respiratory infections.

Psychosocial emergency care in times of COVID-19: the Essen University Hospital concept for corona-infected patients, their relatives, and medical staff.

Due to the SARS CoV-2-virus (COVID-19), anxiety, distress, and insecurity occur more frequently. In particular, infected individuals, their relatives, and medical staff face an increased risk of high psychological distress as a result of the ongoing pandemic. Thus, structured psychosocial emergency concepts are needed. The University hospital of Essen has taken up this challenge by creating the PEC concept to reduce psychosocial long-term consequences for infected patients, relatives, and medical staff at the university hospital. The concept includes professional medical as well as psychological support to convey constructive coping strategies and the provision of adequate tools such as the low-threshold online training program (CoPE It), which is accessible via the webpage www.cope-corona.de .

COVID-19 pandemic: Practical considerations on the organization of an allergy clinic-An EAACI/ARIA Position Paper.

BACKGROUND: The coronavirus disease 2019 (COVID-19) has evolved into a pandemic infectious disease transmitted by the severe acute respiratory syndrome coronavirus (SARS-CoV-2). Allergists and other healthcare providers (HCPs) in the field of allergies and associated airway diseases are on the front line, taking care of patients potentially infected with SARS-CoV-2. Hence, strategies and practices to minimize risks of infection for both HCPs and treated patients have to be developed and followed by allergy clinics. METHOD: The scientific information on COVID-19 was analysed by a literature search in MEDLINE, PubMed, the National and International Guidelines from the European Academy of Allergy and Clinical Immunology (EAACI), the Cochrane Library, and the internet. RESULTS: Based on the diagnostic and treatment standards developed by EAACI, on international information regarding COVID-19, on guidelines of the World Health Organization (WHO) and other international organizations, and on previous experience, a panel of experts including clinicians, psychologists, IT experts, and basic scientists along with EAACI and the "Allergic Rhinitis and its Impact on Asthma (ARIA)" initiative have developed recommendations for the optimal management of allergy clinics during the current COVID-19 pandemic. These recommendations are grouped into nine sections on different relevant aspects for the care of patients with allergies. CONCLUSIONS: This international Position Paper provides recommendations on operational plans and procedures to maintain high standards in the daily clinical care of allergic patients while ensuring the necessary safety measures in the current COVID-19 pandemic.