Respiratory biofeedback and psycho-education for patients with post COVID- 19 symptoms and bodily distress: study protocol of the randomized, controlled explorative intervention trial POSITIV

BACKGROUND: A high number of individuals report suffering from physical and psychological sequelae symptoms after COVID-19-the so-called post COVID-19 condition. Commonly reported complaints include physical symptoms such as fatigue, headache, attention and concentration deficits or dyspnea and anxiety, symptoms of post-traumatic stress, or depression. Evidence-based treatment recommendations are still lacking up to this point. Associations between physical and psychological symptoms in chronic diseases are known for a long time. Support in coping with the disease and improvement of self-efficacy can have a positive effect on the course of diseases. For this reason, we designed a randomized, controlled explorative intervention trial as a treatment of bodily distress disorder in COVID-19 recovered persons. METHODS: Patients with a post COVID-19 condition meeting to the criteria of the WHO, along with a bodily distress disorder, are randomized in an intervention and control arm (TAU). Randomization takes place after a diagnostic interview, screening, and informed consent. In total, 60 patients will be included in the trial (30 per group). The intervention group receives a cognitive behavioral therapy as a video-conference-based group therapy (6 weeks) and mobile, respiratory biofeedback treatment (for 4 weeks). At several time points, both groups are assessed in terms of psychological and physical health status, treatment expectation, and satisfaction with the intervention. Furthermore, they will get biofeedback examination appointments. The primary outcome is the change in self-efficacy; secondary outcomes include assessed parameters of mental health, somatic symptoms, and satisfaction with the intervention. Data will be analyzed primarily using R and SPSS. DISCUSSION: The randomized, controlled, explorative intervention trial POSITIV is one of the very first interventions for patients with post COVID-19 condition and psychological burden due to their different symptoms. The aim of the study is to generate new evidence and help patients to cope with the disease and thus, increase their quality of life and reduce symptomatology. We expect with a high probability that the patients' self-efficacy and health status will improve as a result of the intervention. TRIAL REGISTRATION: German Clinical Trial Register (DRKS); DRKS-ID: DRKS00030565. Registered on December 22, 2022.