Publications

Background Adverse effects of chronically high levels of stress on physical and mental health are well established. In physicians, the effects of elevated stress levels exceed the individual level and …ss levels exceed the individual level and include treatment errors and reduced quality of patient-doctor relationships. Breathing and mindfulness-based exercises have been shown to reduce stress and could serve as an immediate and easy-to-implement anti-stress intervention among physicians. Due to the heterogeneity of their effect on stress, we aim to evaluate the intervention effect of performing a short daily breathwork-based or mindfulness-based intervention on the everyday level of perceived stress in physicians in residence in Germany in a series of N-of-1 trials. Methods Study participants will choose between two short interventions, box breathing, and one guided more complex mindfulness-based breathing exercise. Each participant subsequently will be randomly allocated to a sequence of 1-week intervention (A) and control (B, everyday life) phases. Each N-of-1 trial consists of two two-week cycles (AB or BA), resulting in a total trial duration of 4 weeks (ABAB or BABA). Perceived levels of stress will be assessed daily via the StudyU App on the participant’s smartphone. Additionally, participants will be asked to complete a questionnaire at baseline and three months after completion of the study that contains questions about basic participant characteristics, lifestyle factors, individual living situations, and validated psychological questionnaires. Intervention effects will be estimated by Bayesian multi-level random effects models on the individual and population level. Discussion This study contributes to the development of short-term solutions to reduce work-related stress for physicians in residence. This is expected to benefit the individual and increase the quality of overall healthcare due to a reduction in treatment errors and an increase in the quality of doctor-patient relationships. Clinical trial registration ClinicalTrials.gov , identifier NCT05745545.

Abstract Background Antidepressant discontinuation is associated with a broad range of adverse effects. Debilitating discontinuation symptoms can impede the discontinuation process and contribute to …an impede the discontinuation process and contribute to unnecessary long-term use of antidepressants. Antidepressant trials reveal large placebo effects, indicating a potential use of open-label placebo (OLP) treatment to facilitate the discontinuation process. We aim to determine the effect of OLP treatment in reducing antidepressant discontinuation symptoms using a series of N-of-1 trials. Methods A series of randomized, single-blinded N-of-1 trials will be conducted in 20 patients with fully remitted DSM-V major depressive disorder, experiencing moderate to severe discontinuation symptoms following antidepressant discontinuation. Each N-of-1 trial consists of two cycles, each comprising two-week alternating periods of OLP treatment and of no treatment in a random order, for a total of eight weeks. Our primary outcome will be self-reported discontinuation symptoms rated twice daily via the smartphone application ‘StudyU’. Secondary outcomes include expectations about discontinuation symptoms and (depressed) mood. Statistical analyses will be based on a Bayesian multi-level random effects model, reporting posterior estimates of the overall and individual treatment effects. Discussion Results of this trial will provide insight into the clinical application of OLP in treating antidepressant discontinuation symptoms, potentially offering a new cost-effective therapeutic tool. This trial will also determine the feasibility and applicability of a series of N-of-1 trials in a clinical discontinuation trial. Trial registration ClinicalTrials.gov: NCT05051995, first registered September 20, 2021.