Sleep Health Interventions for Shift Work Sleep Disorder

(OSHIN Trial)

Overseen By Lucy Kozii, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oregon State University

Must not be taking: Some insomnia treatments

Disqualifiers: Uncontrolled conditions, Seizures, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 10 weeks

60 Participants Needed

Trial Summary

What is the purpose of this trial?

The aim of the proposed study is to pilot test two behavioral sleep intervention strategies for improving insomnia among night shift working nurses.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude some current treatments for insomnia. It's best to discuss your specific medications with the trial coordinators.

What data supports the effectiveness of the treatment Cognitive Behavioral Therapy for Insomnia (CBT-I) for shift work sleep disorder?

Research shows that Cognitive Behavioral Therapy for Insomnia (CBT-I) is effective in improving sleep issues, including for shift workers, by enhancing sleep efficiency and reducing insomnia symptoms. Although tailored approaches may be needed for shift workers, studies indicate significant improvements in sleep quality and overall wellbeing with CBT-I. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy for Insomnia (CBTI) safe for humans?

Cognitive Behavioral Therapy for Insomnia (CBTI) is considered a safe treatment for insomnia and is recommended as a standard treatment by health authorities like the National Institutes of Health and the American Academy of Sleep Medicine. It is a non-drug approach that focuses on changing sleep habits and behaviors, and it has been shown to be effective without significant safety concerns. ^{1 6 7 8 9}

How is the treatment CBTI, MRTI for shift work sleep disorder different from other treatments?

CBTI (Cognitive Behavioral Therapy for Insomnia) and MRTI (Mindfulness Relaxation Training for Insomnia) are unique because they are non-drug treatments that focus on changing sleep-related behaviors and thoughts, offering long-term benefits without the side effects of medication. Unlike standard treatments, these therapies can be personalized and delivered online, making them accessible and adaptable for shift workers. ^{1 4 10 11 12}

Research Team

Jessica Dietch, PhD

Principal Investigator

Oregon State University

Eligibility Criteria

This trial is for night shift working nurses in Oregon who have insomnia or sleep issues and expect to keep their schedule during the study. They must be able to use the internet daily and read/write English. Nurses on certain insomnia treatments, with uncontrolled medical conditions, seizure history, safety risks, or expecting pregnancy can't join.

Inclusion Criteria

Expect to continue on shift work schedule during the study

I have severe trouble sleeping.

Have daily access to internet on a smartphone, tablet, or computer

Exclusion Criteria

Permanent day, evening, or rotating shift schedule

I have had seizures or manic episodes in the past.

People with uncontrolled medical conditions

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either cognitive-behavioral therapy for insomnia or multicomponent relaxation therapy for insomnia, conducted over telehealth

10 weeks

Follow-up

Participants are monitored for changes in insomnia severity, fatigue, and sleep-related impairment

4 weeks

Treatment Details

Interventions

• CBTI
• MRTI

Trial Overview The study tests two behavioral strategies for better sleep among nurses working at night: Cognitive Behavioral Therapy for Insomnia (CBTI) and Morning Routine Therapy for Insomnia (MRTI). It aims to see which helps improve sleep quality.

Participant Groups

Group I: MRTI Experimental Treatment 1 Intervention

Multicomponent Relaxation Therapy for Insomnia

Group II: CBTI Experimental Treatment 1 Intervention

Cognitive Behavioral Therapy for Insomnia

CBTI is already approved in United States, European Union for the following indications:

Approved in United States as Cognitive Behavioral Therapy for Insomnia for:

• Chronic insomnia disorder
• Primary insomnia
• Insomnia occurring in the context of medical and psychiatric comorbidity

Approved in European Union as Cognitive Behavioral Therapy for Insomnia for:

• Chronic insomnia disorder
• Primary insomnia
• Insomnia occurring in the context of medical and psychiatric comorbidity

Who Is Running the Clinical Trial?

Oregon State University

Lead Sponsor

Trials

51

Recruited

8,300+

Monash University

Collaborator

Trials

204

Recruited

10,570,000+

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

American Academy of Sleep Medicine

Collaborator

Trials

29

Recruited

3,000+

Findings from Research

Cognitive behavioral therapy for insomnia (CBTi) is a highly effective non-drug treatment for insomnia, showing comparable efficacy to sleep medications in randomized control trials, with better long-term maintenance of benefits after treatment ends.

Due to its strong empirical support, both the National Institutes of Health and the American Academy of Sleep Medicine recommend CBTi as the standard treatment for insomnia, highlighting its importance in addressing the public health burden of this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insomnia and its effective non-pharmacologic treatment. Siebern, AT., Manber, R.[2018]

Cognitive behavioral therapy for insomnia (CBT-I) was effective in improving insomnia symptoms over a 24-month follow-up among 59 media workers, with 62% of participants showing moderate improvement.

The study found that working hour arrangements did not impact the effectiveness of CBT-I, indicating that this treatment can benefit both daytime and shift workers with chronic insomnia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for chronic insomnia in occupational health services: analyses of outcomes up to 24 months post-treatment. Järnefelt, H., Sallinen, M., Luukkonen, R., et al.[2018]

Cognitive Behavioral Treatment for Insomnia (CBTI) is highly effective, showing significant improvements in various sleep measures across 87 randomized controlled trials involving 3724 patients, with an overall effect size of 0.98 for insomnia severity.

Face-to-face CBTI treatments with at least four sessions are more effective than shorter or self-help interventions, and the effectiveness of CBTI remains consistent across different patient demographics and comorbid conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive and behavioral therapies in the treatment of insomnia: A meta-analysis. van Straten, A., van der Zweerde, T., Kleiboer, A., et al.[2022]

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 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 randomized controlled trial is evaluating the effectiveness of provider-supported self-help Cognitive Behavioral Therapy for Insomnia (Tele-Self CBTi) in veterans with insomnia, aiming to improve access to treatment for this population with significant sleep difficulties.

If proven effective, Tele-Self CBTi could serve as a crucial entry-level intervention for veterans, potentially addressing the high demand for insomnia treatment and improving overall health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Provider-supported self-management cognitive behavioral therapy for insomnia (Tele-Self CBTi): Protocol for a randomized controlled trial. Ulmer, CS., Bosworth, HB., Zervakis, J., et al.[2023]

Cognitive Behavioral Therapy for Insomnia (CBTI) is the preferred treatment for chronic insomnia, but many patients opt for medication due to cost and availability issues.

Internet-based CBTI (I-CBTI) is well-accepted by patients and significantly improves insomnia symptoms, suggesting it could be a valuable alternative for those unable to access traditional CBTI.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Delivered Cognitive Behavioral Therapy for Insomnia: Tailoring Cognitive Behavioral Therapy for Insomnia for Patients with Chronic Insomnia. van der Zweerde, T., Lancee, J., Ida Luik, A., et al.[2020]

Internet-based cognitive behavioral therapy for insomnia (I-CBTI) is a highly acceptable treatment option that significantly improves insomnia symptoms for patients who may not have access to traditional CBTI.

The effectiveness of I-CBTI can vary based on specific treatment characteristics and individual patient factors, suggesting that tailoring the approach could enhance outcomes for different patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet-Delivered Cognitive Behavioral Therapy for Insomnia: Tailoring Cognitive Behavioral Therapy for Insomnia for Patients with Chronic Insomnia. van der Zweerde, T., Lancee, J., Ida Luik, A., et al.[2019]

A survey of 154 military sleep health care providers revealed that while 68% reported availability of cognitive-behavioral treatment for insomnia (CBTI/BBTI), less than 50% of patients diagnosed with insomnia actually receive these treatments, indicating a significant gap in care.

Key barriers to implementing CBTI/BBTI include under-resourced clinics and scheduling limitations, while facilitators include having trained providers and leadership support, suggesting that improving resources and workflows could enhance insomnia treatment for service members.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survey of Resources in Behavioral Sleep Medicine Across the Department of Defense, Defense Health Agency. Germain, A., Wolfson, M., Klenczar, B., 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]

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 (CBT-I) did not show significant differences in sleep improvement compared to a sleep hygiene intervention among 83 shift workers with insomnia, indicating that both approaches may be similarly effective.

Group-based CBT-I was particularly beneficial for improving mood symptoms, while participants without Shift Work Disorder (SWD) experienced greater overall improvements than those with SWD, suggesting that the severity of insomnia and associated mental health issues may influence treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioural therapy interventions for insomnia among shift workers: RCT in an occupational health setting. Järnefelt, H., Härmä, M., Sallinen, M., et al.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Insomnia and its effective non-pharmacologic treatment. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for chronic insomnia in occupational health services: analyses of outcomes up to 24 months post-treatment. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Cognitive and behavioral therapies in the treatment of insomnia: A meta-analysis. [2022]

4. 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]

5. 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]

6. United States pubmed.ncbi.nlm.nih.gov

Provider-supported self-management cognitive behavioral therapy for insomnia (Tele-Self CBTi): Protocol for a randomized controlled trial. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Internet-Delivered Cognitive Behavioral Therapy for Insomnia: Tailoring Cognitive Behavioral Therapy for Insomnia for Patients with Chronic Insomnia. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Internet-Delivered Cognitive Behavioral Therapy for Insomnia: Tailoring Cognitive Behavioral Therapy for Insomnia for Patients with Chronic Insomnia. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Survey of Resources in Behavioral Sleep Medicine Across the Department of Defense, Defense Health Agency. [2023]

10. Netherlands pubmed.ncbi.nlm.nih.gov

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

11. 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]

12. Germany pubmed.ncbi.nlm.nih.gov

Cognitive behavioural therapy interventions for insomnia among shift workers: RCT in an occupational health setting. [2021]