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ReCOVer: A Randomised Controlled Trial testing the efficacy of Cognitive Behavioural Therapy for preventing chronic postinfectious fatigue among patients diagnosed with COVID-19.

ReCOVer: A Randomised Controlled Trial testing the efficacy of Cognitive Behavioural Therapy for preventing chronic postinfectious fatigue among patients diagnosed with COVID-19. - ReCOVer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON50042
Enrollment
114
Registered
2020-09-14
Start date
2020-11-12
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vermoeidheid fatigue Postinfectious chronic fatigue

Interventions

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, grade

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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 (= 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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)