ReCOVer: A Randomised Controlled Trial testing the efficacy of Cognitive Behavioural Therapy for severe fatigue among patients diagnosed with COVID-19.
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 114
研究概览
简要总结
Patients who received CBT were significantly less severely fatigued across follow-up assessments compared to patients receiving CAU (-8.8, (95% confidence interval (CI)) -11.9 to -5.8); P<0.001), representing a medium Cohen’s d effect size (0.69). The between-group difference in fatigue severity was present at T1 -9.3 (95% CI -13.3 to -5.3) and T2 -8.4 (95% CI -13.1 to -3.7). All secondary outcomes favored CBT. Eight adverse events were reported during CBT, and 20 during CAU. No serious adverse events were recorded. There was no indication that patients following CBT deteriorated with respect to fatigue severity. A uncontrolled long-term follow-up study revealed that favorable outcomes of CBT targeting severe fatigue following COVID-19 are maintained at least up to one year post-intervention. Publications: Kuut, T.A., Müller, F., Aldenkamp, A. et al. 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 22, 867 (2021). https://doi.org/10.1186/s13063-021-05569-y Efficacy of Cognitive-Behavioral Therapy Targeting Severe Fatigue Following Coronavirus Disease 2019: Results of a Randomized Controlled Trial, Clinical Infectious Diseases, Volume 77, Issue 5, 2023; Pages 687–695, https://doi.org/10.1093/cid/ciad257 Letter to the editor: Positive effects of cognitive-behavioral therapy targeting severe fatigue following COVID-19 are sustained up to one year after treatment, Clinical Infectious Diseases, 2023; ciad661, "
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- The patient was diagnosed with symptomatic COVID-19, confirmed by a positive PCR for SARS-CoV-2, another positive NAAT test (RT-PCR, LAMP, TMA or mPOCT), positive SARS-CoV-2 serology, a positive Antigen test or CORADS 4 or 5 on CT-scan; - The patient is 3 up to and including 12 months after being diagnosed with COVID-19 or after hospital discharge in case the patient was admitted; - The patient experiences severe levels of fatigue (= 35 on the fatigue 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; - The patient reports physical disability (= 65 on the Rand36 physical functioning subscale) and/or social disability (= 10 on the Work and Social Adjustment Scale [WSAS]); - The patient is 18 years of age or older; - The patient has sufficient command of the Dutch language.
排除标准
- •- The patient has an already known psychiatric or somatic condition that can explain his/her fatigue. We will also screen for the presence of Post-Traumatic Stress Disorder ([PTSD], (PCL-5) which prevalence may be high in this patient group because of traumatic experiences during the acute phase of COVID-19. We will also screen for the presence of depressive disorder (Mini- International Neuropsychiatric Interview); - The patient currently participates in a multi-disciplinary rehabilitation programme aimed to ameliorate the consequences of COVID-19; - The patient has objectified hypoxemia in rest for which oxygen therapy at home is indicated.