Evidence map›Paper›PMID 34857010›Full record

ArticleTrials2021

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 and 7 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
3.3field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 37 citations in OpenAlex.

  1. Trial
  2. Efficacy of Cognitive-Behavioral Therapy Targeting Severe Fatigue Following Coronavirus Disease 2019: Results of a Randomized Controlled Trial.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

17 authors at 7 institutions in 2 countries.

T A KuutDepartment of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands. t.kuut@amsterdamumc.nl.ORCID http://orcid.org/0000-0002-1840-1406
F MüllerDepartment of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.
A AldenkampDepartment of Lung Medicine, Catharina Hospital, Eindhoven, The Netherlands.
E Assmann-SchuilwerveDepartment of Medical Psychology, Jeroen Bosch Hospital, Den Bosch, The Netherlands.
A BraamseDepartment of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.
S E GeerlingsDepartment of Internal Medicine, Division Infectious Diseases, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.
K B GibneyVictorian Infectious Diseases Service, Royal Melbourne Hospital, and Department of Infectious Diseases, University of Melbourne, at the Peter Doherty Institute for Infection and Immunity, Melbourne, Victoria, Australia.
R A A KanaanDepartment of Psychiatry, University of Melbourne, Austin Health, Heidelberg, Australia.
P NieuwkerkDepartment of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.
T C Olde HartmanDepartment of Primary and Community Care, Radboud Institute for Health Sciences, Radboud University Medical Center, Nijmegen, The Netherlands.
D PauëlsenDepartment of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.
M PrinsDepartment of Internal Medicine, Division Infectious Diseases, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.
K SliekerDepartment of Internal Medicine, Bernhoven, Uden, The Netherlands.
M Van VugtDivision 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, Amsterdam, The Netherlands.
C P Bleeker-RoversDepartment of Internal Medicine, Radboud university medical center, Nijmegen, The Netherlands.
S P KeijmelDepartment of Internal Medicine, Radboud university medical center, Nijmegen, The Netherlands.
H KnoopDepartment of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands.
Amsterdam University Medical Centers · NLRadboud University Nijmegen · NLGGD Amsterdam · NLJeroen Bosch Ziekenhuis · NLThe Royal Melbourne Hospital · AUThe University of Melbourne · AUZiekenhuis Bernhoven · NL

Funding

ZonMw 10430012010025
6 · The paper itself

Abstract

backgroundCoronavirus 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.

methodThe 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 registrationNetherlands Trial Register NL8947 . Registered on 14 October 2020.

Indexed as

Cognitive Behavioral TherapyCOVID-19FatigueHumansMulticenter Studies as TopicPost-Acute COVID-19 SyndromeRandomized Controlled Trials as TopicSARS-CoV-2Treatment OutcomeCognitive behavioural therapyCOVID-19Internet therapyLong COVIDLong-Haul COVID-19 FatiguePost-Acute Sequelae of SARS-CoV-2 Infection (PASC)Post-COVID-19 syndromeRandomised controlled trialStudy protocol

Identifiers

PMID34857010
PMCPMC8637041
OpenAlexW3217300911

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.