Bright Light Therapy for Post-COVID-19 Fatigue

Study Overview
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Brief Summary
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This is a randomized placebo-controlled trial to examine the efficacy of two-week bright light therapy for patients with post-COVID-19 fatigue.

Detailed Description
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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.

Official Title
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Bright Light Therapy for Post-COVID-19 Fatigue

Conditions
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Post COVID-19 Condition

Intervention / Treatment
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* Device: Bright light therapy
* Device: Dim red light therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized placebo-controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bright light therapy<br>10,000lux bright light | Device: Bright light therapy<br>* Exposure to bright light therapy for 30mins a day for two weeks<br>|
| Experimental: Placebo group<br>50 lux dim red light | Device: Dim red light therapy<br>* Exposure to 50lux dim red light therapy for 30mins a day for two weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of fatigue symptoms | Change in the score of the Brief Fatigue Inventory (BFI). BFI ranges from 0 to 90, higher scales indicates more severe fatigue | at 2 weeks (at the end of treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of insomnia symptoms | The change in the score of Insomnia Severity Index (ISI), which ranges from 0-28, higher score indicates higher severity of insomnia | at 2 weeks (at the end of treatment) | 
| Change of depressive symptoms | The change in the score of Patient Health Questionnaire -9 item (PHQ-9), which ranges from 0-27, with higher score indicates greater severity of depressive symptoms | at 2 weeks (at the end of treatment) | 
| Change of anxiety symptoms | The change in the score of Generalized Anxiety Disorder 7-item (GAD-7), which ranges from 0-21, with higher score indicates greater severity of anxiety symptoms | at 2 weeks (at the end of treatment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Long COVID, COVID-19, Fatigue