ReCOVer: Cognitive Behavioural Therapy for post-COVID-19 fatigue

The COVID-19 pandemic is a serious health crisis that will likely result in debilitating long-term symptoms in a large group of patients. As acute fatigue is among the most common symptoms in patients with COVID-19, post-infectious chronic fatigue, a debilitating long-term symptom with severe adverse impact on patients’ health and functioning, is a major concern. Cognitive Behavioural Therapy [CBT] is an evidence-based treatment for severe fatigue among various populations, but it has not been tested in COVID-19 patients. Until now, CBT has generally been tested in populations with a long symptom duration. As there is evidence that a long symptom duration is associated with a less favourable outcome of CBT, we expect timely delivery to help prevent the severe fatigue to become chronic. The aim of this study is to test the efficacy of timely delivered internet-based Cognitive Behavioural Therapy [iCBT] for severe fatigue compared to care as usual.

Primary Objective: To investigate whether timely delivery of iCBT will lead to a significantly lower mean fatigue severity score (CIS-fatigue) across follow-up visits (T1 and T2) as compared to care as usual. Secondary Objectives: To investigate whether timely delivery of iCBT as compared to care as usual will result in: (a) a higher proportion of patients no longer meeting the cutoff score for severe fatigue (i.e. caseness as defined by a CIS-fatigue score of >= 35) at follow-up visits; (b) a higher proportion of patients no longer meeting the cut-off score (as defined in a)) and additionally reporting a clinical significant change (i.e. Reliable Change Index) in fatigue severity at follow-up visits; (c) a lower proportion of patients with chronic fatigue (i.e. caseness as defined in a) and self-reported 6 months duration of fatigue; (d) a significantly higher mean physical functioning as assessed with the RAND-36 across follow-up visits (T1 and T2); (e) a significantly lower mean level on the work and social adjustments scale (WSAS) across follow-up visits (T1 and T2); (f) a significantly lower mean level of somatic symptoms as assessed with the PHQ-15 across follow-up visits (T1 and T2). (g) a significantly lower mean level of cognitive symptoms as assessed with the subscale concentration problems of the CIS across follow-up assessments (T1 and T2). All the aboves will be tested in an iterim analysis at T1 only.

Screening for eligibility T0 – Baseline assessment. Randomisation: Stratified by (1) illness severity (no admission, admission non-ICU, admission ICU) and (2) MRC dyspnoea score (<3 vs ≥ 3). T1 – 19 weeks after randomization After T1: interim analysis T2 – 6 months after T1

Patients will be randomised to either iCBT or care as usual (ratio 1:1). iCBT The intervention to be delivered is internet-based Cognitive Behavioural Therapy [iCBT]. This intervention is based on the cognitive-behavioural model of fatigue, stating that disease and/or its treatment initially triggers fatigue while cognitive-behavioural variables perpetuate fatigue. Patients randomised to iCBT will receive 17 weeks of individual iCBT, based on an existing treatment manual for chronic fatigue which has been adapted to COVID-19. iCBT will be delivered by trained cognitive-behavioural therapists on a secured webportal and entails up to 9 modules. Of these modules, 7 target the perpetuating factors of fatigue. Patients only receive modules that are indicated for them, based on baseline scores (T0) and intake. Patients who are not able or willing to follow iCBT will be offered face-to-face CBT at a treatment facility or via video consults using the same treatment manual. Care as usual Currently, care as usual for patients who passed the acute phase of COVID-19 can entail different forms of care. Participants will have no access to the study intervention during the study period, but are not restrained from using any care for their fatigue or a related symptoms/health complaints (e.g. through referral by their practitioner).