To investigate whether delivering timely Cognitive Behavioural Therapy [CBT], an evidence-based treatment for chronic fatigue, is effective in preventing the development of post-COVID-19 chronic fatigue.
A substantial subgroup of COVID-19 patients is expected to develop post-COVID-19 chronic fatigue, i.e. severe fatigue persisting for more than 6 months with accompanying detrimental effects on patient health, functioning and societal participation.
Quickly gathering evidence on the efficacy of internet based CBT (iCBT) to prevent post-COVID-19 chronic fatigue and its possible consecutive implementation is a unique opportunity to help to alleviate the pandemic’s negative impact on patient health and on the wider society.
It is hypothesized that timely offering iCBT for fatigue, i.e. 3 to 6 months after COVID-19 diagnosis or hospital discharge, will lead to a significant and clinically relevant reduction in fatigue severity (primary outcome) following the intervention, will reduce the proportion of patients who progress to chronic fatigue at follow-up and foster patients’ work ability, physical and social functioning and reduce other somatic symptoms as compared to care as usual.
PLAN VAN AANPAK
We propose a 2-arm randomised controlled trial l in which patients who have recovered from acute COVID-19 but suffer from ongoing severe and debilitating fatigue are randomised to either iCBT or care as usual. The project will be conducted within 24 months. Primary outcome is patients’ fatigue severity, as assessed with the CIS-fatigue at follow up (T1, T2). A sample of 114 patients (57 in each arm) will suffice to identify clinical relevant differences in fatigue severity. Recruitment will be conducted within existing COVID-19 cohorts, among outpatient clinics of participating hospitals, from referrals of general practitioners or self-referrals. Offering CBT as internet-based intervention fits within the current social distancing measures.