Psychological risk factors for Long COVID and their modification: study protocol of a three-arm, randomised controlled trial (SOMA.COV).

BACKGROUND: Growing evidence suggests that in addition to pathophysiological, there are psychological risk factors involved in the development of Long COVID. Illness-related anxiety and dysfunctional symptom expectations seem to contribute to symptom persistence. AIMS: With regard to the development of effective therapies, our primary aim is to investigate whether symptoms of Long COVID can be improved by a targeted modification of illness-related anxiety and dysfunctional symptom expectations. Second, we aim to identify additional psychosocial risk factors that contribute to the persistence of Long COVID, and compare them with risk factors for symptom persistence in other clinical conditions. METHOD: We will conduct an observer-blinded, three-arm, randomised controlled trial. A total of 258 patients with Long COVID will be randomised into three groups of equal size: targeted expectation management in addition to treatment as usual (TAU), non-specific supportive treatment plus TAU, or TAU only. Both active intervention groups will comprise three individual online video consultation sessions and a booster session after 3 months. The primary outcome is baseline to post-interventional change in overall somatic symptom severity. CONCLUSIONS: The study will shed light onto the action mechanisms of a targeted expectation management intervention for Long COVID, which, if proven effective, can be used stand-alone or in the context of broader therapeutic approaches. Further, the study will enable a better understanding of symptom persistence in Long COVID by identifying additional psychological risk factors.

[Pneumological Rehabilitation in Patients with Long Covid - Health Changes at the End of the Inpatient Rehabilitation Measure]. / Pneumologische Rehabilitation bei Long Covid ­ Gesundheitliche Veränderungen am Ende der stationären Rehabilitationsmaßnahme.

BACKGROUND: Some people suffering from Covid-19 can be affected by persistent symptoms and long-term consequences of the disease (Long Covid) beyond their acute phase. Consequently, this can lead to restrictions in participation. Therefore, the focus is on medical rehabilitation in which Long Covid is treated as a new challenge. METHODS: A prospective, exploratory observational study will be conducted. The written survey of Long Covid rehabilitants takes place at the beginning and end of the pneumological rehabilitation. The aim of the study is to describe the rehabilitation contents and goals, the subjective burdens, the social and occupational participation as well as the health-related changes. Among other factors, disease-specific symptoms, quality of life, participation, psychological impairments, fatigue, and performance were recorded. RESULTS: Long Covid rehabilitants (N=221) participate in the written survey. At the end of rehabilitation, the questionnaire survey indicated significant improvements in almost all outcome parameters with a large effect (p<0.01; ES between 0.76 (anxiety) and 1.30 (fatigue)). All corona symptoms, such as breathlessness on exertion, fatigue or lack of strength improved significantly at the end of rehabilitation. Moreover, the rehabilitants most frequently name the improvement of their health (92%), the increase of their performance (92%) and the improvement of the respiratory muscle strength (78%) as rehabilitation goals. In fact, these goals are achieved by 60 to 70%, significantly fewer rehabilitation patients reach the restoration of their ability to work (32%) or a better ability to concentrate (17%). Respiratory physiotherapy, endurance training and medical training therapy are described as most helpful. At the end of rehabilitation, 76% rated their rehabilitation success as good to excellent based on a single question. CONCLUSION: The first data of the study reveal that Long Covid rehabilitants are exposed to substantial burdens. Through medical rehabilitation, the patients experience medical and social support and experience significant improvements in all recorded health-related outcomes.

Study protocol medical rehabilitation after COVID-19 disease: an observational study with a comparison group with obstructive airway disease / Re_Co.

BACKGROUND: Novel coronavirus disease 2019 (COVID-19) has been the subject of a numerous research projects over the past year. In cases with a severe disease course or threatening long-term impairment due to disease, the German health care system offers insured persons the possibility of medical rehabilitation. In contrast to what was observed and expected at the beginning of the pandemic, COVID-19 patients with varying degrees of disease severity are represented in rehabilitation. To date, there is no common consensus on the content and aftercare of rehabilitation nor is there any knowledge about the short- and long-term effects of such a rehabilitation programme. In addition, these aspects were not considered with regard to the varying severity of the course of the disease. The present research project investigates this question. METHODS: The study sample will consist of N = 350 rehabilitants after COVID-19 and a comparison group (CG) with N = 230 rehabilitants suffering from an obstructive respiratory disease. The participants will be recruited at five German rehabilitation facilities and undergo medical rehabilitation. This prospective, exploratory, multicentre, mixed-methods study will be evaluated as follows: (A) The quantitative portion includes questionnaires at different points in time (at the beginning and end of rehabilitation, after six and twelve months) and contains standardised measurement instruments. For example, participation limitations, quality of life, health status, fatigue, psychomental limitations and disorders, performance in different areas of life and ability to work are measured. (B) Qualitative interviews are held at different times (end of rehabilitation, after six and twelve months), and an expert workshop is conducted. Topics are rehabilitation content, satisfaction and aftercare as well as different outcomes on subjective health and participation impairments. DISCUSSION: Studies on other indications have already shown that pneumological rehabilitation has positive effects. Thus, it is expected that an improvement in different dimensions will be observed at the end of rehabilitation in both groups. With regard to the different severities of COVID-19, this study evaluates the long-term developments. Subsequently, the authors will elaborate concrete recommendations for medical rehabilitation after different courses of disease with regard to existing pneumological rehabilitation concepts. TRIAL REGISTRATION: German Register of Clinical Trials, www.drks.de .Identifier: DRKS00023642; Registered: 01.12.2020.Date and version identifier: 08.04.2021; version 4.