Accepted for/Published in: JMIR Research Protocols
Date Submitted: Aug 13, 2023
Date Accepted: Dec 6, 2023
Mental Disorder Symptoms and Fatigue in Long COVID-19: A Prospective Cohort Multicenter Observational Study
ABSTRACT
Background:
Long COVID comprises, among others, symptoms of fatigue, myalgia, and mental impairments.
Objective:
This study aims to quantify the degree of physical and psychological fatigue in post-COVID-19 patients and assess the correlation of fatigue with some mental disorders.
Methods:
Using a consecutive, non-random sampling technique, a prospective cohort multicenter observational study with the recruitment of adult patients in the post-COVID-19 medical consultation of five Portuguese hospitals. Consenting, symptomatic patients with previous COVID-19 infection attending the post-COVID-19 follow-up consultation of the study centres will be enrolled. We will include patients that had mild, moderate, and severe acute disease. The assessment of clinical severity outcomes related to COVID-19 encompassed the type of respiratory support as high-flow nasal cannula (HFNC), non-invasive ventilation (NIV), and invasive mechanical ventilation (IMV). Exclusion criteria will be previous severe psychiatric disorders confirmed by a psychiatrist, refusal, or inability to respond to the questionnaire; concomitant neurological disorder; persistent fatigue symptoms during the six months before SARS-CoV-2 infection; and need for invasive mechanical ventilation during COVID-19 infection, because of high prevalence of post intensive care syndrome (PICS) in this subgroup of patients. Our primary outcome is the prevalence of fatigue in patients with post-COVID-19 depression and or anxiety, measured by the Chalder Fatigue Scale (CFQ-11) and Hospital Anxiety and Depression Scale (HADS). The secondary outcomes will be the assessment of health-related quality of life through the EQ-5D questionnaire, and an exploration of the prevalence of symptoms of post-traumatic stress disorder (using the PTSS-14 instrument). We also examine the association between mental symptoms and the severity of acute COVID-19, categorised according to the WHO classification. The post-COVID-19 collected data will be at least six months after the positive test and no longer than nine months during the clinical appointment. All statistical analyses will be made using IBM® SPSS® Statistics v.27. and R. This research provides valuable insights into the mental health implications of COVID-19 and its impact on the post-COVID-19 fatigue and in the overall well-being of affected individuals.
Results:
We expect our multicenter study on post-COVID-19 patients to reveal a significant link between mental health symptoms and both physical and psychological fatigue. Patients with heightened depression and anxiety may report increased levels of fatigue. Additionally, we expect to find persistent PTSD symptoms in a subset of participants, indicating the enduring psychological impact of the virus.
Conclusions:
This research may underscore the need for integrated care addressing physical and mental health in post-COVID-19 patients. The observed connections emphasize the importance of considering mental well-being for long-term health outcomes. Despite study limitations, our findings contribute valuable insights for future treatment strategies and highlight the necessity for comprehensive mental health support in post-COVID-19 care. Clinical Trial: ClinicalTrials.gov NCT05323318
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Copyright
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