Bright Light Therapy for Post-COVID-19 Fatigue
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change of fatigue symptoms
研究概览
简要总结
This is a randomized placebo-controlled trial to examine the efficacy of two-week bright light therapy for patients with post-COVID-19 fatigue.
详细描述
This randomized placebo-controlled trial aims to evaluate the efficacy of BLT in reducing fatigue symptoms after COVID-19 infection. The second aim of the study is to explore the effects of BLT on insomnia, depression and anxiety symptoms.
Method: Each eligible participant will be randomized to either i) bright light therapy (BLT) or ii) dim red light (placebo) treatment for 30-minutes daily at their habitual wake time for a total of two weeks. Participants will be evaluated at baseline, 2nd (end of treatment), and 4th week (post-treatment 2-week) for fatigue and other symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
The subjects will be explained that the study aims to test the efficacy of two different modalities of light treatments for fatigue including white light and red light, without mentioning which one is the placebo.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or above
- •Capable to give informed consent
- •COVID-19 infection confirmed by PCR test or a Rapid Antigen Test (RAT) with onset of at least three months
- •Reports new onset or exacerbation of fatigue after onset of COVID-19 and lasted for over two months
- •Scoring 7 or above for the item "worst level of fatigue during the last 24 hours" in the Brief Fatigue Inventory
排除标准
- •A current or past history of bipolar disorder, schizophrenia, neurodevelopmental disorder, organic mental disorder; intellectual disabilities or substance use disorder.
- •Presence of contraindications to bright light therapy: for example, history of light induced migraine/ epilepsy; current use of photosensitizing medications; presence of eye disease: e.g. retinal blindness, severe cataract, glaucoma.
- •Significant medical condition/ hearing impairment/ speech deficit leading to incapability of completing clinical interview.
- •Regular shift-workers
- •Trans-meridian flight in the past 3 months and during the study
- •Currently receiving any structured psychotherapy
- •Self-reported untreated sleep disorders (e.g. severe insomnia, obstructive sleep apnea, restless leg syndrome), psychiatric illness (e.g. depression), or medical conditions associated with fatigue (e.g. anemia, heart failure, autoimmune disorders)
- •Enrolment in another clinical trial of an investigational medicinal product or device.
结局指标
主要结局
Change of fatigue symptoms
时间窗: at 2 weeks (at the end of treatment)
Change in the score of the Brief Fatigue Inventory (BFI). BFI ranges from 0 to 90, higher scales indicates more severe fatigue
次要结局
- Change of insomnia symptoms(at 2 weeks (at the end of treatment))
- Change of depressive symptoms(at 2 weeks (at the end of treatment))
- Change of anxiety symptoms(at 2 weeks (at the end of treatment))
研究者
Joey WY Chan
Associate Professor (Clinical)
Chinese University of Hong Kong