Bright Light Therapy for Post-COVID-19 Fatigue

Not Applicable

Recruiting

• Conditions: Post COVID-19 Condition
• Interventions: Device: Dim red light therapy; Device: Bright light therapy

• Registration Number: NCT05677932
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-01-06
• Study First Submitted QC: 2023-01-09
• Study First Posted: 2023-01-10
• Study Start: 2023-02-15
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-07
• Last Update Posted: 2023-03-09
• Primary Completion: 2024-02-28
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Dim red light therapy	50 lux dim red light
Bright light therapy	Bright light therapy	10,000lux bright light

Primary Outcome Measures

Name	Time	Method
Change of fatigue symptoms	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

Secondary Outcome Measures

Name	Time	Method
Change of insomnia symptoms	at 2 weeks (at the end of treatment)	The change in the score of Insomnia Severity Index (ISI), which ranges from 0-28, higher score indicates higher severity of insomnia
Change of depressive symptoms	at 2 weeks (at the end of treatment)	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
Change of anxiety symptoms	at 2 weeks (at the end of treatment)	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

Trial Locations

Locations (1)

The Chinese University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong