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· 3 Minuten Lesezeit

We are pleased to announce that the "Anti-Stress Intervention Among Physicians (ASIP)" Study utilizes StudyU to investigate the following intriguing and pertinent research question:

How can the everyday level of perceived stress be reduced in a fast and easy-to-implement manner?

The project will be conducted in cooperation with the Institute for Public Health at Charité – Universitätsmedizin Berlin (Principal Investigator: Dr. med. Valentin Vetter).

Background

Physicians in Germany generally experience a high level of psychosocial stress. This holds true for those working in hospitals, general practitioners, and physicians in outpatient clinics. It is a well-known fact that high levels of stress negatively impact the physical and mental health of individuals. In physicians' case, however, high stress levels have also been identified as a reason for suboptimal quality of medical care. This includes deviations from standard procedures, a decrease in the quality of the doctor-patient relationship, and treatment errors. Potentially substantial structural changes in the organization and management of health care as well as in the way physicians are compensated by health insurers would be required to achieve sustainable improvements for medical personnel. Hence, a more immediate and easy-to-implement solution to reduce perceived stress is needed.

The Intervention

An intervention to improve the stress level of physicians must meet certain criteria to increase the likelihood of being implemented in everyday life and leading to sustainable improvements. First, the intervention needs to be easy to learn and brief, as time is often limited during a busy workday. Second, the intervention should be conducted without additional tools. Third, the intervention needs to be successful in reducing stress. All the criteria listed above are fulfilled by two techniques that have been intensively studied over the past decades: breathwork and mindfulness-based meditation techniques.

Why Use an N-of-1 Design

Perception of stress is highly individual and dependent on a large number of variables, both known and unknown, which are partly hard to measure accurately. The same is potentially true for the effect of an anti-stress intervention on stress levels. Therefore, a randomized study design is needed to account for all known and unknown confounders. While randomized placebo-controlled trials (RCTs) are often used to assess the effects of interventions, this might not be the ideal design for anti-stress interventions. Firstly, RCTs focus on the outcome effect on the group level but neglect intra-individual effects. However, for an anti-stress intervention, it is much more interesting to analyze the effects of the intervention within the individual (which can differ from between-group effects). Additionally, population-level effects can subsequently be estimated from the data collected in the N-of-1 trial as well, thereby ensuring no insights are lost. Secondly, due to the repeated measurements in an N-of-1 trial, temporal changes can be analyzed. Thirdly, owing to advanced applications like StudyU, the interventions can be applied, and the outcomes measured, in the context of daily life. Due to these (and additional) advantages, N-of-1 trials are "regarded [to be] at the top of the evidence hierarchy [...] over and above systematic reviews of RCTs" (Kwasnicka et al., 2019) for individual treatment choices.

Digital Application of Intervention through StudyU

The StudyU platform contributes to the ASIP Study by providing a user-friendly interface that manages and applies the intervention (through audio/video files) and collects the participant-reported outcome measures. The application will ensure good adherence to the study protocol by presenting the current phase of the trial in a structured and clear way, as well as through push notifications.

· 4 Minuten Lesezeit

We are pleased to announce the publication of the first research paper utilizing the StudyU platform for a medical study. The paper Study protocol: combined N-of-1 trials to assess open-label placebo treatment for antidepressant discontinuation symptoms [FAB-study] was published in cooperation with Universitätsklinikum Hamburg-Eppendorf and Universitätsklinikum Giessen und Marburg, both of them based in Germany.

Let us have a deeper look into the content of this innovative study and what this achievement means for StudyU.

Unlocking the Power of N-of-1 Trials with StudyU

StudyU is a novel platform leading the way in the digital transformation of N-of-1 trials, the gold standard for assessing personalized treatments. N-of-1 trials compare two interventions for each participant to identify the most effective one. Comprising the StudyU Designer for specifying and publishing trials and the StudyU App for participant engagement, the StudyU platform empowers clinicians and researchers globally to conduct secure digital N-of-1 trials. StudyU envisions a future of more accessible and collaborative personalized treatments, available as a free research tool and a versatile resource for clinical practice.

Addressing the Antidepressant Discontinuation Challenge

Antidepressant discontinuation is a complex issue, with many individuals facing adverse effects and symptoms that hinder the process of stopping medication. This can result in unnecessary, long-term use of antidepressants. The FAB-Study acknowledges this challenge and proposes a solution around the concept of N-of-1 trials, which involves individual patients using the StudyU App to provide personalized insights into their treatment.

The FAB-Study: A Closer Look

The FAB-Study involves conducting a series of randomized, single-blinded N-of-1 trials. In total, 20 patients with fully remitted DSM-V major depressive disorder, who are experiencing moderate to severe discontinuation symptoms after stopping antidepressants, participate in the study.

Each N-of-1 trial consists of two cycles, each spanning eight weeks. Within these cycles, patients experience two-week alternating periods of open-label placebo (OLP) treatment and no treatment, in a randomized order. Their self-reported discontinuation symptoms are captured twice daily via our smartphone application, StudyU. Additionally, the study tracks their expectations about discontinuation symptoms and mood states.

More information about the study is available in the open access paper: Study protocol: combined N-of-1 trials to assess open-label placebo treatment for antidepressant discontinuation symptoms [FAB-study]

How StudyU supported the FAB-Study

For the successful execution of a digital N-of-1 study, supportive and patient-friendly tools are essential. Due to the unique nature of N-of-1 trials and their special requirements, the N-of-trial tailored platform StudyU served as a particularly helpful instrument during the implementation of the FAB-Study:

"The new StudyU platform greatly supported the FAB-Study, by serving as an easy-to-use and cost-effective therapeutic tool for us. Working with StudyU proved to be a pleasant experience for both the researchers and our patients. We will definitely consider using StudyU for future N-of-1 studies."

-Amke Müller, study director of the first medical study utilizing StudyU

Promising Potential

The results of the FAB-Study may provide valuable insights into the clinical use of open-label placebos for treating antidepressant discontinuation symptoms. Furthermore, the study not only addresses the clinical challenge at hand but also investigates the feasibility and applicability of a series of N-of-1 trials in a clinical discontinuation trial. Such insights could pave the way for more personalized, patient-centric treatments.

As N-of-1 studies become more widespread, digital N-of-1 platforms could play a vital role in the future in supporting personalized healthcare. They provide the infrastructure needed to streamline the trial process, from specifying interventions to real-time data collection and analysis. In addition, digital N-of-1 platforms play a key role in the adoption of N-of-1 studies, as traditional analog methods had limitations in their implementation.

With digital platforms, such as StudyU, trials can be conducted remotely or via smartphones, enhancing participant engagement and ensuring the accuracy and integrity of the data. The scalability and efficiency they offer make N-of-1 trials more accessible and practical for personalized treatment assessment, holding great promise for the future of healthcare.

Conclusion

As the developers of the StudyU platform, we are pleased to see StudyU being actively used in health research. It makes us proud to see how StudyU contributes to an important research topic in the field of antidepressant discontinuation. The FAB study is an example of the potential of personalized medicine and the central role StudyU can play in this area.

For us, the paper represents a significant step toward enhancing healthcare and improving the lives of patients. We are excited about the future and the possibilities that personalized healthcare, powered by technologies like StudyU, holds.

· 2 Minuten Lesezeit

On June 8, 2023, we had the honor of introducing StudyU to Prof. Dr. Karl Lauterbach, the German Federal Minister of Health, during his visit to the Digital Health Cluster at the Hasso Plattner Institute (HPI). In a engaging discussion with senior researcher Dr. Stefan Konigorski, the minister was able to gain firsthand knowledge about how StudyU offers an empowering opportunity to develop individualized care plans and enhance patient outcomes.

Prof. Lauterbach was already aware of how N-of-1 trials have the potential to provide personalized insights into treatment effectiveness. However, he was impressed to learn that StudyU enables the digital conduction of these trials, making them more accessible and convenient. The digital implementation of N-of-1 trials through StudyU left a lasting positive impression on him, emphasizing the platform's capability to advance personalized healthcare research.

Dr. Stefan Konigorski showcasing the capabilities of StudyU for personalized healthcare interventions to the German Federal Minister of Health, Prof. Dr. Karl Lauterbach

Image credits: Leon Stebe

We want to thank Prof. Dr. Karl Lauterbach for taking his time to visit the Digital Health Cluster at HPI to learn more about StudyU and other ongoing digital health research projects.

Click here to download our new StudyU poster!

· Eine Minute Lesezeit

We are honored to announce that StudyU has won the Best Idea Award 2022 of the School Of Entrepreneurship at Hasso Plattner Institute (HPI).

Winning this award grants us the opportunity to visit HPI New York City and meet its director, Dr. Joann Halpern. Additionally, it enables us to establish connections with HPI・MS, a collaborative project between HPI and Mount Sinai Health System, renowned as one of the world's top-ranked hospitals.

With these new possibilities, our goal is to further enhance the development of StudyU, so that a greater number of individuals will be able to experience the advantages of personalized healthcare interventions.

Many thanks to everyone who voted for us!

Read more on the HPI website: https://hpi.de/entrepreneurship/best-idea.html.

The winning team StudyU with Pauline Gieseler und Johannes Vedder (middle)

Image credits: HPI School Of Entrepreneurship