Light Therapy + Cognitive Behavioral Therapy for Shift Work Sleep Disorder

(REACT Trial)

Overseen By Cynthia Fellman-Couture, RN, BSN, PhD

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

Trial Summary

What is the purpose of this trial?

The purpose of this project is to test sleep reactivity as an independent cause of Shift Work Disorder (SWD). The primary hypothesis is that those with high sleep reactivity will show persistent SWD symptoms after experimental reduction of circadian misalignment, which will then be mitigated with CBT.

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.

What data supports the effectiveness of the treatment Light Therapy + Cognitive Behavioral Therapy for Shift Work Sleep Disorder?

Research shows that Cognitive Behavioral Therapy for Insomnia (CBT-I) can improve sleep efficiency and reduce insomnia symptoms in shift workers. Online and face-to-face CBT-I interventions have been effective, suggesting that combining CBT with light therapy could be beneficial for shift work sleep disorder. ^{1 2 3 4 5}

Is light therapy and cognitive behavioral therapy safe for humans?

Research shows that both light therapy and cognitive behavioral therapy (CBT) are generally safe for humans. Light therapy has been well tolerated in studies, and CBT, including its online versions, has been shown to improve sleep and wellbeing without significant safety concerns. ^{1 2 3 4 6}

How does the treatment of Light Therapy + Cognitive Behavioral Therapy for Shift Work Sleep Disorder differ from other treatments?

This treatment is unique because it combines light therapy, which helps adjust the body's internal clock, with cognitive behavioral therapy (CBT), a first-line treatment for insomnia that can be delivered online for personalization and continuous tracking. This dual approach addresses both the sleepiness and circadian rhythm issues common in shift workers, offering a comprehensive solution not typically found in standard treatments. ^{1 2 3 6 7}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. Canada 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. [2023]

2. Switzerland 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. [2020]

3. England 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. [2023]

4. England 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. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for shift workers with chronic insomnia. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Light therapy with boxes or glasses to counteract effects of acute sleep deprivation. [2021]

7. England 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. [2021]