Telehealth Program for Sleep Disorders

(SWISH Trial)

Overseen By Liudmyla Kozii, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Oregon State University

Must not be taking: Chronic sleep-interfering medications

Disqualifiers: Substance use disorder, Thought disorder, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new telehealth program designed to help shift workers, such as nurses, improve their sleep. It employs a personalized approach based on cognitive behavioral therapy (a type of talk therapy) to address sleep issues. Participants will either begin the program immediately or after a waiting period. This trial suits U.S. nurses who work night shifts at least twice a week and experience poor sleep. As an unphased trial, it provides a unique opportunity for nurses to enhance their sleep through innovative, personalized therapy.

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 excludes those with chronic use of medications that interfere with sleep. If you're using such medications, you might not be eligible to participate.

What prior data suggests that this telehealth program is safe for improving sleep health?

Research has shown that cognitive behavioral therapy for insomnia (CBT-I) is generally safe for shift workers. This therapy improves sleep patterns without causing significant side effects. Specifically, an online CBT program for shift workers improved sleep without major issues. Previous studies have also shown that non-drug sleep treatments like CBT-I are well-tolerated by shift workers. Therefore, for those considering joining a trial using this type of sleep treatment, evidence suggests it is a safe option for managing sleep problems in shift workers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Shift Worker Intervention for Sleep Health (SWISH) because it offers a tailored approach for individuals with sleep disorders, particularly those working irregular hours. Unlike traditional treatments for insomnia, which often involve medication or general cognitive behavioral therapy, SWISH uses a multicomponent behavioral intervention specifically adapted from cognitive behavioral therapy for insomnia to suit shift workers' unique needs. This personalized approach aims to improve sleep quality by addressing the specific challenges faced by shift workers, potentially leading to better adherence and more effective outcomes. Additionally, the use of telehealth makes this treatment more accessible and convenient, allowing participants to receive support without needing to visit a clinic.

What evidence suggests that this telehealth program is effective for sleep disorders?

Research has shown that cognitive behavioral therapy for insomnia (CBT-I) can improve sleep for shift workers, though results vary. Some studies found that CBT-I reduces insomnia severity, but it doesn't always significantly enhance sleep quality. Other research suggests that both group sessions and self-help versions of CBT-I can serve as effective, low-effort treatments. This trial will compare the SWISH intervention, a multicomponent behavioral intervention based on CBT-I, with a waitlist control group. More research is needed to determine the effectiveness of these methods specifically for shift workers. Overall, CBT-I appears promising, but its effectiveness for shift workers remains under study. ^{1 3 4 5 6}

Who Is on the Research Team?

Jessica Dietch, PhD

Principal Investigator

Oregon State University

Are You a Good Fit for This Trial?

This trial is for nurses in Oregon, aged 18-65, who work night shifts or rotating shifts including nights at least three times a week and have been doing so for over three months. Participants must have internet access, be able to read/write in English, consent to the study, expect to continue shift work, and report poor sleep. Excluded are those on certain medications or treatments affecting sleep, with substance abuse issues or severe psychiatric conditions.

Inclusion Criteria

Have daily access to the internet on a smartphone, table, or computer; and

Currently employed as a nurse in the state of Oregon

Can read and write in English.

Exclusion Criteria

Currently participating in other research studies with substantial overlap in terms of methods/procedures (e.g., PI's ongoing study 'Piloting an Adaptation of Cognitive Behavioral Therapy for Insomnia for Shift Workers (CBTI-Shift)'

Conditions which make study treatment likely to be ineffective. For example, current chronic use of medications that interfere with sleep, alcohol or substance use disorder, or thought disorder (as determined by DIAMOND psychiatric interview), unstable sleep or medical conditions that necessitate additional medical care not provided by study treatments (e.g., known untreated sleep apnea)

Presence of safety risk or condition in which study participation may result in increased risk to safety (e.g., elevated risk for suicide, self-reported uncontrolled seizure disorder, history of manic or hypomanic episode, current pregnancy)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the SWISH intervention, a multicomponent behavioral therapy for insomnia, administered via telehealth across approximately weekly sessions

12 weeks

Weekly sessions (telehealth)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Shift Worker Intervention for Sleep Health

Trial Overview The 'SWISH' program is being tested as a telehealth intervention aimed at improving sleep health among shift workers. It's personalized and uses media through devices like smartphones or computers to help manage the unique challenges of shift work-related sleep disturbances.

How Is the Trial Designed?

Group I: SWISH Experimental Treatment 1 Intervention

SWISH, a multicomponent behavioral intervention based on cognitive behavioral therapy for insomnia. Other Names: Cognitive Behavioral Therapy for Insomnia

Group II: WLC Active Control 1 Intervention

Waitlist Control: Participants in the delayed treatment control condition will begin the SWISH intervention following completion of the posttreatment time point.

Who Is Running the Clinical Trial?

Oregon State University

Lead Sponsor

Trials

51

Recruited

8,300+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

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 systematic review of 68 studies on interventions for shiftworkers found that only 60.3% assessed implementation, highlighting a gap in understanding how these interventions are applied in real-world settings.

The average quality of implementation assessment was moderate (2.56 out of 5), and only a small number of studies identified enablers (25%) or barriers (26.5%) to effective implementation, suggesting that future research should focus more on these aspects to improve intervention effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of interventions designed to promote healthy sleep and circadian rhythms in shiftworkers. Harrison, EM., Schmied, EA., Yablonsky, AM., et al.[2021]

The SleepSync mobile app significantly improved various sleep-related outcomes for shift workers, including total sleep time, ability to fall asleep, and sleep quality, based on a trial with 27 participants over two weeks.

Users reported positive engagement and usability with the app, indicating it effectively integrated into their routines and influenced their sleep behaviors, suggesting its potential as a valuable tool for managing sleep in shift workers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile app for personalized sleep-wake management for shift workers: A user testing trial. Murray, JM., Magee, M., Giliberto, ES., et al.[2023]

Shift work affects nearly 20% of the global labor force and is linked to negative impacts on worker health, safety, and quality of life due to disruptions in circadian rhythms and increased sleepiness during shifts.

Management strategies for shift work disorder (SWD) include promoting better sleep and wakefulness, but more research is needed to understand the health risks and develop effective treatments for those affected.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shift work and the assessment and management of shift work disorder (SWD). Wright, KP., Bogan, RK., Wyatt, JK.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7260280/

Cognitive behavioural therapy interventions for insomnia ... Our results showed no significant differences between the sleep improvements of the shift workers in the CBT-I interventions and of those in the ...

2. trialsjournal.biomedcentral.com trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08403-3

Efficacy study comparing a CBT-I developed for shift workers ... As already mentioned above, studies conducted to date using classic CBT-I methods have shown little effect on shift workers.

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1087079222001290

Is cognitive behavioral therapy for insomnia (CBTi) ... Cognitive behavioral therapy for insomnia (CBTi) is the first line treatment for insomnia, however efficacy in shift workers is not well understood.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT02523079

Cognitive Behavioral Therapy for Insomnia Among ... The investigators expect to find that both group and self-help based CBT-I among different types of shift workers are effective low-intensity treatments of ...

5. frontiersin.org frontiersin.org/journals/sleep/articles/10.3389/frsle.2024.1343393/full

Current sleep interventions for shift workers: a mini review ... Findings from a recent meta-analysis revealed that CBT-i significantly reduced insomnia severity and improved sleep quality; however, values did not reach the ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10481224/

Effect of an Internet–Delivered Cognitive Behavioral ... The physician-assisted internet-delivered CBT program targeting shift workers with a high risk of sleep disorders showed a statistically significant increase in ...