Light Therapy + Cognitive Behavioral Therapy for Shift Work Sleep Disorder

(REACT Trial)

Overseen By Marleigh Treger, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Henry Ford Health System

Disqualifiers: Insomnia, Sleep apnea, Bipolar, Neurological, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 6 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether sleep reactivity (how easily sleep is disturbed) influences Shift Work Disorder (SWD). Participants will test light therapy (phototherapy) and Cognitive Behavioral Therapy (CBT) to determine if these treatments reduce SWD symptoms. The study involves experimenting with different light conditions and CBT sessions to enhance sleep patterns for overnight shift workers. This trial suits nightshift workers diagnosed with SWD who experience sleep disturbances due to their work schedule. As an unphased trial, it offers participants the chance to contribute to groundbreaking research that could enhance treatment options for SWD.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that light therapy is usually safe for shift workers and can help them sleep longer and better. However, concerns about eye safety exist. Using lamps that protect the eyes is important to prevent harm to the retina, a part of the eye.

Studies have found that Cognitive Behavioral Therapy (CBT) safely treats sleep problems in shift workers. It reduces insomnia and improves sleep quality. CBT involves changing thoughts and behaviors related to sleep and is considered the best initial treatment for insomnia. Although not specifically designed for shift workers, it remains a safe and helpful option for improving sleep. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it tests an innovative combination of light therapy and cognitive behavioral therapy (CBT) to tackle Shift Work Sleep Disorder, a condition often managed with melatonin or sleep aids. Unlike typical treatments that focus solely on medication, this trial explores how timed bright light exposure can reset the body's internal clock, while CBT addresses the mental and behavioral aspects. The light therapy uses a controlled, individualized bright light schedule to help align the circadian rhythm, while CBT sessions conducted via telemedicine make mental health support more accessible. This dual approach aims to reduce sleepiness during night shifts and improve overall sleep quality, offering a comprehensive solution compared to standard treatments.

What evidence suggests that this trial's treatments could be effective for Shift Work Sleep Disorder?

Research has shown that light therapy, which participants in this trial may receive as part of the active light condition, can help night shift workers by reducing tiredness and improving sleep patterns. One study found that people using light therapy slept longer and experienced better-quality sleep. Another study found that personalized light therapy reduced symptoms of shift work disorder.

In contrast, cognitive behavioral therapy (CBT), another treatment option in this trial, has shown mixed results for shift workers. Some studies report that CBT helps with tiredness, anxiety, and depression, while others found it less effective specifically for shift work. Despite this, CBT remains a common method for addressing sleep problems. ^{1 2 5 6 7}

Are You a Good Fit for This Trial?

This trial is for adults over 18 who work at least three night shifts per week, starting between 6 PM and 2 AM, lasting 8-12 hours. They must have Shift Work Disorder diagnosed by specific criteria and show a certain pattern of sleep hormone timing. Excluded are those with bipolar or neurological disorders, pregnant women, other sleep disorders, drug or alcohol abuse issues, or insomnia predating shift work.

Inclusion Criteria

Participants must show circadian misalignment with a baseline melatonin onset between 18:00 and 01:00

Participants must have Shift Work Disorder diagnosed based on ICSD-3 criteria

I work night shifts starting between 6 PM and 2 AM for at least three nights a week.

Exclusion Criteria

Pregnancy

I have been diagnosed with bipolar disorder.

Illicit drug use determined by self-report and urine drug screen if reasonable suspicion to test

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Circadian Misalignment Reduction

Experimental reduction of circadian misalignment using bright light exposure

2 weeks

In-person visits for light exposure sessions

Treatment

Participants receive CBT or sleep education to probe sleep reactivity

6 weeks

6 telemedicine sessions

Follow-up

Participants are monitored for insomnia and sleepiness post-treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Active phototherapy
• Cognitive Behavioral Therapy (CBT)
• Control phototherapy
• Sleep education control

Trial Overview

The study tests if high sleep reactivity causes persistent Shift Work Disorder symptoms after reducing circadian misalignment. It involves comparing active phototherapy and Cognitive Behavioral Therapy (CBT) against control phototherapy and basic sleep education to see which helps better.

How Is the Trial Designed?

Group I: Cognitive Behavioral Therapy (CBT) condition Experimental Treatment 1 Intervention

The CBT condition will probe sleep reactivity using validated CBT strategies over 6 sessions in accordance with the two-factor theory of emotion. Behavioral strategies will be used to reduce physiological arousal (e.g., relaxation training, breathing) and to strengthen behavioral cues for sleep (e.g., sleep hygiene and sleep scheduling). Sleep times will be scheduled to align with the reduced circadian misalignment (compromised phase position, i.e., maintaining a slightly delayed sleep period on offwork days). Cognitive strategies will identify stressors (e.g., dysfunctional beliefs about sleep) and intervene on worry and rumination with cognitive reappraisal and active coping. Sessions will be conducted by a trained behavioral sleep medicine provider via telemedicine to increase accessibility.

Group II: Active light condition Experimental Treatment 1 Intervention

Timed bright light exposure will be delivered in a controlled laboratory setting (10,000 lux) designed to delay the DLMO to 4 am or later. This would shift the circadian nadir (e.g., the period of maximal sleepiness) into the typical daytime sleep period after the nightshift (i.e., circadian nadir at \~10am). Bright light will be delivered in a controlled lab environment using a full spectrum light-box with UV filter (Sunbox Sunray II) to achieve a robust reduction of circadian misalignment. The light schedule will be tailored to each individual nightshift worker, determined by: 1) their baseline circadian phase, and 2) the human phase response curve adjusted to the individual's baseline circadian phase.

Group III: Control light condition Active Control 1 Intervention

Shift workers randomized to the control condition will receive less intense light that still has a perceptible alerting effect (100 photopic lux). However, light will occur during a portion of the phase response curve with minimal phase shifts.

Group IV: Sleep education control condition Active Control 1 Intervention

This condition will use an established sleep education control protocol modified for nightshift workers based on the "Plain Language about Shiftwork" published by the National Institute for Occupational Safety and Health (NIOSH). Sleep duration recommendations will be equivalent to the CBT group (8 hours of sleep opportunity) to ensure that outcomes are not confounded by time in bed. Materials in the sleep education control condition will be separated into weekly electronic materials monitored for engagement and completion.

Cognitive Behavioral Therapy (CBT) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cognitive Behavioral Therapy for:

• Chronic pain
• Anxiety disorders
• Depressive disorders
• Trauma-related disorders

Approved in European Union as Cognitive Behavioural Therapy for:

• Chronic pain
• Anxiety disorders
• Depressive disorders
• Trauma-related disorders

Approved in Canada as Cognitive Behavioral Therapy for:

• Chronic pain
• Anxiety disorders
• Depressive disorders
• Trauma-related disorders

Who Is Running the Clinical Trial?

Henry Ford Health System

Lead Sponsor

Trials

334

Recruited

2,197,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

In a study involving 18 participants, early morning light therapy using either a 10,000 Lux light box or 2,000 Lux LED blue-enriched glasses significantly improved alertness, cognition, and mood after a night of complete sleep deprivation.

Both light therapy devices were equally effective and well-tolerated, suggesting that early light exposure can be a practical solution to counteract the negative effects of sleep deprivation, especially for shift workers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Light therapy with boxes or glasses to counteract effects of acute sleep deprivation. Comtet, H., Geoffroy, PA., Kobayashi Frisk, M., et al.[2021]

A 4-week online cognitive behavioral therapy for insomnia (CBT-I) significantly improved sleep efficiency by 7.2% in a group of 21 shift workers, showing it as a feasible treatment option.

Both online and face-to-face CBT-I interventions led to significant improvements in sleep quality and wellbeing, with no notable difference in effectiveness between the two methods, indicating that online therapy can be as effective as traditional in-person treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of an Online CBT-I Intervention and a Face-to-Face Treatment for Shift Work Sleep Disorder: A Comparison of Sleep Diary Data. Peter, L., Reindl, R., Zauter, S., et al.[2020]

A 4-week internet-delivered cognitive behavioral therapy (CBT) program significantly increased sleep duration among 61 shift workers, from an average of 5.54 hours to 6.06 hours per night, indicating its efficacy in addressing sleep disorders in this population.

Participants also reported improved subjective sleep quality, with scores on the Pittsburgh Sleep Quality Index decreasing from 9.10 to 7.84 after the intervention, suggesting that the program effectively enhanced overall sleep satisfaction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of an Internet-Delivered Cognitive Behavioral Therapy-Based Sleep Improvement App for Shift Workers at High Risk of Sleep Disorder: Single-Arm, Nonrandomized Trial. Ito-Masui, A., Sakamoto, R., Matsuo, E., et al.[2023]

Cognitive behavioral therapy for insomnia (CBTi) shows modest improvements in insomnia symptoms among shift workers, with mean differences of -3.08 on the Insomnia Severity Index and -2.38 on the Pittsburgh Sleep Quality Index, but these changes are not clinically significant.

The review highlights the need for tailored CBTi approaches specifically designed for shift workers, as current interventions may not adequately address their unique challenges related to sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is cognitive behavioral therapy for insomnia (CBTi) efficacious for treating insomnia symptoms in shift workers? A systematic review and meta-analysis. Reynolds, AC., Sweetman, A., Crowther, ME., et al.[2023]

A scoping review of 14 clinical trials on interventions for shift work-related sleep disturbances revealed a variety of approaches, including pharmacological treatments (hypnotics and stimulants) and non-pharmacological therapies (like cognitive behavioral therapy and light therapy), but no consistent outcomes were reported across studies.

The review highlights the need for adequately powered trials and the development of standardized outcome measures to better evaluate the effectiveness of interventions for shift work sleep disorder, as current evidence is fragmented and lacks progression from efficacy trials to broader applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A scoping review of the evidence for the impact of pharmacological and non-pharmacological interventions on shift work related sleep disturbance in an occupational setting. Conway-Jones, R., Dunlop, E., Kyle, S., et al.[2023]

Light therapy is effective in reducing sleepiness and shifting circadian phases in shift workers, with a meta-analysis of 21 studies showing small to medium effects on sleepiness and large effects on circadian phase shift.

Medium-intensity light therapy for shorter durations is best for reducing nighttime sleepiness, while higher-intensity light therapy is more effective for inducing circadian phase shifts, although the optimal treatment duration is still unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose-response effects of light therapy on sleepiness and circadian phase shift in shift workers: a meta-analysis and moderator analysis. Lam, C., Chung, MH.[2021]

A cognitive behavioral group intervention for insomnia (CBT-I) was effective in improving sleep quality and reducing insomnia symptoms among 19 shift workers over a 6-month follow-up period, with significant enhancements in sleep onset latency and overall sleep efficiency.

Participants reported better sleep on their days off compared to work days, but the CBT-I treatment improved sleep quality on both types of days, indicating its potential effectiveness for shift workers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for shift workers with chronic insomnia. Järnefelt, H., Lagerstedt, R., Kajaste, S., et al.[2018]

Citations

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nature.com

nature.com/articles/s41598-024-83789-3

A systematic review and meta-analysis on light therapy for ...

The results showed that light therapy significantly improved the total sleep time (TST) (MD = 32.54, p < 0.00001) and sleep efficiency (SE) (MD ...

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academic.oup.com

academic.oup.com/sleep/article/47/Supplement_1/A11/7654305

0027 Personalized Light Therapy for Night Shift Work

This randomized controlled trial extends prior findings by examining the effect of personalized light therapy on symptoms of shift work disorder.

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withpower.com/trial/phase-disease-1-2022-bb0c2

Phototherapy for Shift Work Sleep Disorder (SHIFT Trial)

The available research shows that phototherapy can effectively reduce sleepiness and adjust the sleep schedule for shift workers. A meta-analysis found that ...

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pmc.ncbi.nlm.nih.gov

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The Effectiveness of Low-Level LED Light Therapy for ...

Low-level light-emitting diode light therapy improved sleep quality in shift-work nurses with insomnia and alleviated depression, anxiety, and stress symptoms.

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nature.com

nature.com/articles/s41598-021-89321-1

Dose–response effects of light therapy on sleepiness and ...

Light therapy has been considered to be effective in mitigating sleepiness and regulating circadian phase shift in shift workers.

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clinicaltrials.gov/study/NCT05424406?tab=table

Role of Sleep Reactivity in Shift Work Disorder

Two-step mechanistic randomized controlled trial design stratified by high and low sleep reactivity. Step 1: active versus control light therapy; Step 2: ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9430001/

Impact of light therapy on rotating night shift workers

Our results revealed that intermittent light therapy had no impact on inflammatory parameters or glucose tolerance in a defined cohort of r-NSWs.