ReCOVer: A Randomised Controlled Trial testing the efficacy of Cognitive Behavioural Therapy for preventing chronic postinfectious fatigue among patients diagnosed with COVID-19.
- Conditions
- VermoeidheidfatiguePostinfectious chronic fatigue10002252
- Registration Number
- NL-OMON50042
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 114
In order to be eligible to participate in this study, a subject must meet all
of the following criteria:
1. The patient was diagnosed with symptomatic COVID-19, confirmed by a positive
PCR for SARS-CoV-2, positive SARS-CoV-2 serology or CORADS 5 on CT-scan, or had
typical symptoms and was part of a household in which another person was tested
positive by PCR 2 weeks before or after the first day of illness;
2. The patient is 3 to 6 months after being diagnosed with COVID-19 or after
hospital discharge in case the patient was admitted. If the number of new
COVID-19 cases is very small and not enough patients can be recruited 3-6
months post COVID-19, we will extent the period in which patients can be
recruited first to 9 months post COVID-19 and, in the unlikely case this still
would not suffice, up to 12 months;
3. The patient experiences severe levels of fatigue (>= 35 on the fatigue
severity subscale of the Checklist Individual Strength [CIS-fatigue]). The
severe fatigue started with or increased substantially directly after the onset
of symptoms of COVID-19;
4. The patient reports physical/social disability (<= 65 on the Rand36 physical
functioning subscale or a score of >= 10 on the Work and Social Adjustment Scale
[WSAS]);
5. The patient is 18 years of age or older;
6. The patient has sufficient command of the Dutch language.
A potential subject who meets any of the following criteria will be excluded
from participation in this study:
1. The patient has an already known psychiatric or somatic condition that can
explain the presence of fatigue. We will also screen for the presence of
Post-Traumatic Stress Disorder [PTSD] which prevalence may be high in this
patient group because of traumatic experiences during the acute phase of
COVID-19. These patients will be referred for PTSD treatment;
2. The patient currently participates in a multi-disciplinary rehabilitation
programme aimed to ameliorate the consequences of COVID-19;
3. The patient has objectified hypoxemia in rest for which oxygen therapy at
home is indicated.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To investigate whether timely delivery of iCBT, i.e. 3 to 6 months after<br /><br>COVID-19 diagnosis or hospital discharge, will lead to a significant reduction<br /><br>in fatigue severity (CIS-fatigue) between baseline (T0) and the post-assessment<br /><br>(T1, T2) as compared to care as usual.</p><br>
- Secondary Outcome Measures
Name Time Method <p>To investigate whether timely delivery of iCBT will lead to a clinically<br /><br>relevant reduction in fatigue, reduce the proportion of patients who progress<br /><br>to chronic fatigue (i.e. caseness) and will foster patients* work ability,<br /><br>physical and social functioning and will reduce other somatic symptoms as<br /><br>compared to care as usual.</p><br>