NL-OMON50042已完成不适用
ReCOVer: A Randomised Controlled Trial testing the efficacy of Cognitive Behavioural Therapy for preventing chronic postinfectious fatigue among patients diagnosed with COVID-19. - ReCOVer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •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
- •5. The patient is 18 years of age or older;
- •6. The patient has sufficient command of the Dutch language.
排除标准
- •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.
研究者
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