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
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...
| Main Authors: | , , , , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMC
2021-12-01
|
| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-021-05569-y |
| _version_ | 1818401487114469376 |
|---|---|
| author | 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 |
| author_facet | 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 |
| author_sort | T. A. Kuut |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-14T07:53:15Z |
| format | Article |
| id | doaj.art-c75c9f4e9f324d1aa334ace51d1aac03 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-14T07:53:15Z |
| publishDate | 2021-12-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-c75c9f4e9f324d1aa334ace51d1aac032022-12-21T23:10:39ZengBMCTrials1745-62152021-12-0122111510.1186/s13063-021-05569-yA randomised controlled trial testing the efficacy of Fit after COVID, a cognitive behavioural therapy targeting severe post-infectious fatigue following COVID-19 (ReCOVer): study protocolT. A. Kuut0F. Müller1A. Aldenkamp2E. Assmann-Schuilwerve3A. Braamse4S. E. Geerlings5K. B. Gibney6R. A. A. Kanaan7P. Nieuwkerk8T. C. Olde Hartman9D. Pauëlsen10M. Prins11K. Slieker12M. Van Vugt13C. P. Bleeker-Rovers14S. P. Keijmel15H. Knoop16Department of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam Public Health Research InstituteDepartment of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam Public Health Research InstituteDepartment of Lung Medicine, Catharina HospitalDepartment of Medical Psychology, Jeroen Bosch HospitalDepartment of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam Public Health Research InstituteDepartment of Internal Medicine, Division Infectious Diseases, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam Public Health Research InstituteVictorian Infectious Diseases Service, Royal Melbourne Hospital, and Department of Infectious Diseases, University of Melbourne, at the Peter Doherty Institute for Infection and ImmunityDepartment of Psychiatry, University of MelbourneDepartment of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam Public Health Research InstituteDepartment of Primary and Community Care, Radboud Institute for Health Sciences, Radboud University Medical CenterDepartment of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam Public Health Research InstituteDepartment of Internal Medicine, Division Infectious Diseases, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam Public Health Research InstituteDepartment of Internal Medicine, BernhovenDivision of Internal Medicine, Department of Infectious Diseases, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam Institute for Infection and Immunity, Amsterdam Public Health Research InstituteDepartment of Internal Medicine, Radboud university medical centerDepartment of Internal Medicine, Radboud university medical centerDepartment of Medical Psychology, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam Public Health Research InstituteAbstract 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.https://doi.org/10.1186/s13063-021-05569-yCognitive behavioural therapyCOVID-19Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)Post-COVID-19 syndromeLong COVIDLong-Haul COVID-19 Fatigue |
| spellingShingle | 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 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 Trials Cognitive behavioural therapy COVID-19 Post-Acute Sequelae of SARS-CoV-2 Infection (PASC) Post-COVID-19 syndrome Long COVID Long-Haul COVID-19 Fatigue |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Cognitive behavioural therapy COVID-19 Post-Acute Sequelae of SARS-CoV-2 Infection (PASC) Post-COVID-19 syndrome Long COVID Long-Haul COVID-19 Fatigue |
| url | https://doi.org/10.1186/s13063-021-05569-y |
| work_keys_str_mv | AT takuut arandomisedcontrolledtrialtestingtheefficacyoffitaftercovidacognitivebehaviouraltherapytargetingseverepostinfectiousfatiguefollowingcovid19recoverstudyprotocol AT fmuller arandomisedcontrolledtrialtestingtheefficacyoffitaftercovidacognitivebehaviouraltherapytargetingseverepostinfectiousfatiguefollowingcovid19recoverstudyprotocol AT aaldenkamp arandomisedcontrolledtrialtestingtheefficacyoffitaftercovidacognitivebehaviouraltherapytargetingseverepostinfectiousfatiguefollowingcovid19recoverstudyprotocol AT eassmannschuilwerve arandomisedcontrolledtrialtestingtheefficacyoffitaftercovidacognitivebehaviouraltherapytargetingseverepostinfectiousfatiguefollowingcovid19recoverstudyprotocol AT abraamse arandomisedcontrolledtrialtestingtheefficacyoffitaftercovidacognitivebehaviouraltherapytargetingseverepostinfectiousfatiguefollowingcovid19recoverstudyprotocol AT segeerlings arandomisedcontrolledtrialtestingtheefficacyoffitaftercovidacognitivebehaviouraltherapytargetingseverepostinfectiousfatiguefollowingcovid19recoverstudyprotocol AT kbgibney arandomisedcontrolledtrialtestingtheefficacyoffitaftercovidacognitivebehaviouraltherapytargetingseverepostinfectiousfatiguefollowingcovid19recoverstudyprotocol AT raakanaan arandomisedcontrolledtrialtestingtheefficacyoffitaftercovidacognitivebehaviouraltherapytargetingseverepostinfectiousfatiguefollowingcovid19recoverstudyprotocol AT pnieuwkerk arandomisedcontrolledtrialtestingtheefficacyoffitaftercovidacognitivebehaviouraltherapytargetingseverepostinfectiousfatiguefollowingcovid19recoverstudyprotocol AT tcoldehartman arandomisedcontrolledtrialtestingtheefficacyoffitaftercovidacognitivebehaviouraltherapytargetingseverepostinfectiousfatiguefollowingcovid19recoverstudyprotocol AT dpauelsen arandomisedcontrolledtrialtestingtheefficacyoffitaftercovidacognitivebehaviouraltherapytargetingseverepostinfectiousfatiguefollowingcovid19recoverstudyprotocol AT mprins arandomisedcontrolledtrialtestingtheefficacyoffitaftercovidacognitivebehaviouraltherapytargetingseverepostinfectiousfatiguefollowingcovid19recoverstudyprotocol AT kslieker arandomisedcontrolledtrialtestingtheefficacyoffitaftercovidacognitivebehaviouraltherapytargetingseverepostinfectiousfatiguefollowingcovid19recoverstudyprotocol AT mvanvugt arandomisedcontrolledtrialtestingtheefficacyoffitaftercovidacognitivebehaviouraltherapytargetingseverepostinfectiousfatiguefollowingcovid19recoverstudyprotocol AT cpbleekerrovers arandomisedcontrolledtrialtestingtheefficacyoffitaftercovidacognitivebehaviouraltherapytargetingseverepostinfectiousfatiguefollowingcovid19recoverstudyprotocol AT spkeijmel arandomisedcontrolledtrialtestingtheefficacyoffitaftercovidacognitivebehaviouraltherapytargetingseverepostinfectiousfatiguefollowingcovid19recoverstudyprotocol AT hknoop arandomisedcontrolledtrialtestingtheefficacyoffitaftercovidacognitivebehaviouraltherapytargetingseverepostinfectiousfatiguefollowingcovid19recoverstudyprotocol AT takuut randomisedcontrolledtrialtestingtheefficacyoffitaftercovidacognitivebehaviouraltherapytargetingseverepostinfectiousfatiguefollowingcovid19recoverstudyprotocol AT fmuller randomisedcontrolledtrialtestingtheefficacyoffitaftercovidacognitivebehaviouraltherapytargetingseverepostinfectiousfatiguefollowingcovid19recoverstudyprotocol AT aaldenkamp randomisedcontrolledtrialtestingtheefficacyoffitaftercovidacognitivebehaviouraltherapytargetingseverepostinfectiousfatiguefollowingcovid19recoverstudyprotocol AT eassmannschuilwerve randomisedcontrolledtrialtestingtheefficacyoffitaftercovidacognitivebehaviouraltherapytargetingseverepostinfectiousfatiguefollowingcovid19recoverstudyprotocol AT abraamse randomisedcontrolledtrialtestingtheefficacyoffitaftercovidacognitivebehaviouraltherapytargetingseverepostinfectiousfatiguefollowingcovid19recoverstudyprotocol AT segeerlings randomisedcontrolledtrialtestingtheefficacyoffitaftercovidacognitivebehaviouraltherapytargetingseverepostinfectiousfatiguefollowingcovid19recoverstudyprotocol AT kbgibney randomisedcontrolledtrialtestingtheefficacyoffitaftercovidacognitivebehaviouraltherapytargetingseverepostinfectiousfatiguefollowingcovid19recoverstudyprotocol AT raakanaan randomisedcontrolledtrialtestingtheefficacyoffitaftercovidacognitivebehaviouraltherapytargetingseverepostinfectiousfatiguefollowingcovid19recoverstudyprotocol AT pnieuwkerk randomisedcontrolledtrialtestingtheefficacyoffitaftercovidacognitivebehaviouraltherapytargetingseverepostinfectiousfatiguefollowingcovid19recoverstudyprotocol AT tcoldehartman randomisedcontrolledtrialtestingtheefficacyoffitaftercovidacognitivebehaviouraltherapytargetingseverepostinfectiousfatiguefollowingcovid19recoverstudyprotocol AT dpauelsen randomisedcontrolledtrialtestingtheefficacyoffitaftercovidacognitivebehaviouraltherapytargetingseverepostinfectiousfatiguefollowingcovid19recoverstudyprotocol AT mprins randomisedcontrolledtrialtestingtheefficacyoffitaftercovidacognitivebehaviouraltherapytargetingseverepostinfectiousfatiguefollowingcovid19recoverstudyprotocol AT kslieker randomisedcontrolledtrialtestingtheefficacyoffitaftercovidacognitivebehaviouraltherapytargetingseverepostinfectiousfatiguefollowingcovid19recoverstudyprotocol AT mvanvugt randomisedcontrolledtrialtestingtheefficacyoffitaftercovidacognitivebehaviouraltherapytargetingseverepostinfectiousfatiguefollowingcovid19recoverstudyprotocol AT cpbleekerrovers randomisedcontrolledtrialtestingtheefficacyoffitaftercovidacognitivebehaviouraltherapytargetingseverepostinfectiousfatiguefollowingcovid19recoverstudyprotocol AT spkeijmel randomisedcontrolledtrialtestingtheefficacyoffitaftercovidacognitivebehaviouraltherapytargetingseverepostinfectiousfatiguefollowingcovid19recoverstudyprotocol AT hknoop randomisedcontrolledtrialtestingtheefficacyoffitaftercovidacognitivebehaviouraltherapytargetingseverepostinfectiousfatiguefollowingcovid19recoverstudyprotocol |