German Clinical Trials Register

Acronym/abbreviation of the study

VAST

URL of the study

No Entry

Brief summary in lay language

The positive effects of mind-body practices (e.g. yoga, meditation, tai chi) have long been well known. Thereby, slow breathing in a certain beat is an essential part of these practices. A systematic review of a total of 58 clinical studies concluded that relevant improvements in emotional and physical health and performance can be achieved through breathing-based biofeedback (Lehrer et al. 2020, DOI: 10.1007/s10484-020-09466-z). In all of these studies, slow paced breathing at the so-called resonance frequency was used. This resonance breathing involves breathing at a rate of 6 breaths per minute in a specific pattern that increases the activity of the vagus nerve (called vagus nerve stimulation). The vagus nerve is one of the largest and most widely branched nerves of the autonomic nervous system, originating directly in the brain (10th cranial nerve) and connecting it to all organs in the body. It also has connections with the immune system that can reduce inflammation in the body. Thus, regular, consistent use of this type of stimulation can so significantly improve emotional and physical health. In the strictly randomized controlled BEAT-COVID study, we have already been able to lower the body-wide inflammatory response in COVID-19 patients admitted to the infection ward in the hospital through resonance breathing (Balint et al. 2022, DOI: 10.3389/fimmu.2022.928979, DRKS00023971). Another of our clinical studies shows that patients with a wide range of psychosomatic disorders often show slightly elevated levels of inflammation as well as various difficulties in the area of emotion regulation. The aim of the VAST study is to improve low-threshold inflammation and the ability to regulate emotions through the daily application of a vagus-stimulating breathing technique (resonance breathing) in patients of the University Clinic for Psychosomatic Medicine and Psychotherapy in Ulm. The study participation lasts a total of four months with a total of four on-site examination appointments. Participants will receive a total of €80 for full participation (€20 per examination appointment).

Brief summary in scientific language

Scientific studies show positive effects of mind-body practices, especially resonance breathing, also on the health of patients with psychosomatic disorders. These practices, which include yoga, meditation, and tai chi, have long been shown to have positive effects on the body and mind. A significant feature of these techniques is slow paced breathing (called resonance breathing). A meta-analysis of 58 studies, as described in Lehrer et al. (2020, DOI: 10.1007/s10484-020-09466-z), has shown significant improvements in emotional and physical health and performance, with statistically significant mean effect sizes. In particular, "HRV biofeedback" has been focused on. Interestingly, most of these studies use simple resonance breathing with a general breathing rate of 6 breaths per minute, rather than determining the individual resonance rate more precisely. This greatly simplifies the application in practice. A significant finding from a clustered randomized controlled trial (RCT) (Caldwell & Steffen, 2018, DOI: 10.1016/j.ijpsycho.2018.01.001) is that a slow abdominal breathing technique with 6 breaths per minute produces increased heart rate variability (HRV). This improvement in HRV shows a large effect and has a significant impact on reducing depression symptoms. Other research, such as the study conducted by Reiner (2008, DOI: 10.1007/s10484-007-9046-6), confirms that resonance breathing reduces state and trait anxiety in ambulatory patients when used regularly over several weeks. In addition, recent neuroimaging studies have demonstrated that prolonged breathing interventions induce morphological changes in the brain in healthy participants. Interestingly, the brain areas affected overlap with regions that show changes in patients with mental disorders (Sharma & Newberg, 2015, DOI: 10.2174/2210676605666150311223728). Away from these positive neurobiological effects, numerous experimental studies show that resonance breathing can activate homeostatic mechanisms. This occurs through modulation of the autonomic nervous system, including neuroendocrine responses, inflammatory activity, and cardiovascular function. Increased levels of pro-inflammatory cytokines such as interleukin-6 (IL-6) and C-reactive protein (CRP), which are associated with more severe clinical symptoms, have been observed in patients with psychosomatic disorders, such as depression or chronic pain disorders. At the same time, reduced vagal-mediated HRV was also observed in these patients. It is suspected that the reduction of vagal-mediated HRV via the so-called cholinergic anti-inflammatory pathway (Pavlov & Tracey, 2017, DOI: 10.1038/nn.4477) has an influence on systemic inflammation levels and could be a potential cause for the chronic increase in inflammation. For example, in our own study (BEAT-COVID), we demonstrated that inflammatory levels were significantly reduced the following day, respectively, after performing resonance breathing in hospitalized patients with COVID-19 (Balint et al. 2022, DOI: 10.3389/fimmu.2022.928979, DRKS00023971). The present VAST study aims to investigate the efficacy of a breathing intervention in patients at the University Hospital for Psychosomatic Medicine and Psychotherapy in Ulm, Germany. It is investigated whether resonance breathing before or during inpatient or day clinic therapy leads to an additional improvement of the emotion regulation ability in patients with depression, anxiety and somatoform disorders.