To investigate whether timely delivery of CBT, i.e. 3 to 6 months after COVID-19 diagnosis or hospital discharge, will lead to a significant relevant reduction in fatigue severity (primary outcome), will lead to a clinically relevant reduction in…
ID
Source
Brief title
Condition
- Other condition
- Ancillary infectious topics
Synonym
Health condition
Vermoeidheid
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To investigate whether timely delivery of iCBT, i.e. 3 to 6 months after
COVID-19 diagnosis or hospital discharge, will lead to a significant reduction
in fatigue severity (CIS-fatigue) between baseline (T0) and the post-assessment
(T1, T2) as compared to care as usual.
Secondary outcome
To investigate whether timely delivery of iCBT will lead to a clinically
relevant reduction in fatigue, reduce the proportion of patients who progress
to chronic fatigue (i.e. caseness) and will foster patients* work ability,
physical and social functioning and will reduce other somatic symptoms as
compared to care as usual.
Background summary
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, postinfectious
chronic fatigue, a debilitating long-term symptom with severe adverse impacts
on patients* health and functioning, is a major concern. Timely delivery of
Cognitive Behavioural Therapy [CBT], an evidence-based treatment for chronic
fatigue, is promising to prevent that patients progress from acute to chronic
fatigue.
Study objective
To investigate whether timely delivery of CBT, i.e. 3 to 6 months after
COVID-19 diagnosis or hospital discharge, will lead to a significant relevant
reduction in fatigue severity (primary outcome), will lead to a clinically
relevant reduction in fatigue, will reduce the proportion of patients who
progress to chronic fatigue, will foster patients* work ability, physical and
social functioning and will reduce other somatic symptoms (secondary outcomes)
as compared to care as usual.
Study design
This is a multicentre 2-arm Randomised Controlled Trial. Patients will be
randomised to internet-based CBT [iCBT] or care as usual (ratio 1:1).
Self-report assessments will take place at three to four time points: before
randomisation (T0, baseline), after iCBT or the care as usual period (T1, 4
months after randomisation), 6 months (T2, follow-up) and 12 months later (T3,
CBT-arm only).
Intervention
iCBT will be delivered by trained cognitive-behavioural therapists on a secured
webportal (Minddistrict) during 17 weeks and entails up to 8 modules (e.g.
sleep-wake pattern, helpful thinking, graded activity). A detailed description
of the modules can be found elsewhere (document 'C1. Onderzoekprotocol
ReCOVer').
Patients randomised to care as usual will self-report their care use.
Study burden and risks
Study participation is estimated to take 16 months (incl. T3 for the CBT-arm),
which includes iCBT delivery (or care as usual) and three to four questionnaire
assessments. Patients in the iCBT arm will receive therapy for their fatigue,
which is expected to be effective. Their potential benefit will be decreased
fatigue severity and related benefits (see secondary outcomes). Patients will
have to invest time for responding to questionnaires (± 45 min. at T0, ± 30
min. at T1 to T3) and, if randomised to the iCBT arm, to follow the
intervention. There are no health risks. As CBT can be delivered in its
internet-based format and surveys can be completed online, the travel required
is limited to T0 (collecting the actigraph) and the study can proceed despite
preventive measures due to the COVID-19 pandemic.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
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.
Exclusion criteria
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL74828.018.20 |