A randomised controlled trial testing the efficacy of Fit after COVID, a cognitive behavioural therapy targeting severe post-infectious fatigue following COVID-19 (ReCOVer): study protocol
T. A. Kuut,
F. Müller,
A. Aldenkamp,
E. Assmann-Schuilwerve,
A. Braamse,
S. E. Geerlings,
K. B. Gibney,
R. A. A. Kanaan,
P. Nieuwkerk,
T. C. Olde Hartman,
D. Pauëlsen,
M. Prins,
K. Slieker,
M. Van Vugt,
C. P. Bleeker-Rovers,
S. P. Keijmel,
H. Knoop
Affiliations
T. A. Kuut
Department of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam Public Health Research Institute
F. Müller
Department of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam Public Health Research Institute
A. Aldenkamp
Department of Lung Medicine, Catharina Hospital
E. Assmann-Schuilwerve
Department of Medical Psychology, Jeroen Bosch Hospital
A. Braamse
Department of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam Public Health Research Institute
S. E. Geerlings
Department of Internal Medicine, Division Infectious Diseases, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam Public Health Research Institute
K. B. Gibney
Victorian Infectious Diseases Service, Royal Melbourne Hospital, and Department of Infectious Diseases, University of Melbourne, at the Peter Doherty Institute for Infection and Immunity
R. A. A. Kanaan
Department of Psychiatry, University of Melbourne
P. Nieuwkerk
Department of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam Public Health Research Institute
T. C. Olde Hartman
Department of Primary and Community Care, Radboud Institute for Health Sciences, Radboud University Medical Center
D. Pauëlsen
Department of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam Public Health Research Institute
M. Prins
Department of Internal Medicine, Division Infectious Diseases, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam Public Health Research Institute
K. Slieker
Department of Internal Medicine, Bernhoven
M. Van Vugt
Division of Internal Medicine, Department of Infectious Diseases, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam Institute for Infection and Immunity, Amsterdam Public Health Research Institute
C. P. Bleeker-Rovers
Department of Internal Medicine, Radboud university medical center
S. P. Keijmel
Department of Internal Medicine, Radboud university medical center
H. Knoop
Department of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam Public Health Research Institute
Abstract Background Coronavirus disease 2019 (COVID-19) results in debilitating long-term symptoms, often referred to as Post-Acute Sequelae of SARS-CoV-2 Infection (PASC), in a substantial subgroup of patients. One of the most prevalent symptoms following COVID-19 is severe fatigue. Prompt delivery of cognitive behavioural therapy (CBT), an evidence-based treatment that has shown benefit in reducing severe fatigue in other conditions, may reduce post-COVID-19 fatigue. Based on an existing CBT protocol, a blended intervention of 17 weeks, Fit after COVID, was developed to treat severe fatigue after the acute phase of infection with SARS-CoV-2. Method The ReCOVer study is a multicentre 2-arm randomised controlled trial (RCT) to test the efficacy of Fit after COVID on severe post-infectious fatigue. Participants are eligible if they report severe fatigue 3 up to and including 12 months following COVID-19. One hundred and fourteen participants will be randomised to either Fit after COVID or care as usual (ratio 1:1). The primary outcome, the fatigue severity subscale of the Checklist Individual Strength (CIS-fatigue), is assessed in both groups before randomisation (T0), directly post CBT or following care as usual (T1), and at follow-up 6 months after the second assessment (T2). In addition, a long-term follow-up (T3), 12 months after the second assessment, is performed in the CBT group only. The primary objective is to investigate whether CBT will lead to a significantly lower mean fatigue severity score measured with the CIS-fatigue across the first two follow-up assessments (T1 and T2) as compared to care as usual. Secondary objectives are to determine the proportion of participants no longer being severely fatigued (operationalised in different ways) at T1 and T2 and to investigate changes in physical and social functioning, in the number and severity of somatic symptoms and in problems concentrating across T1 and T2. Discussion This is the first trial testing a cognitive behavioural intervention targeting severe fatigue after COVID-19. If Fit after COVID is effective in reducing fatigue severity following COVID-19, this intervention could contribute to alleviating the long-term health consequences of COVID-19 by relieving one of its most prevalent and distressing long-term symptoms. Trial registration Netherlands Trial Register NL8947 . Registered on 14 October 2020.
