Sleep Well: Digital Insomnia Treatment Program For Physicians

Overseen By Rebecca E Rottapel, MS, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Disqualifiers: Shift work, Excessive sleepiness, Bipolar, Seizure, others

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

Compensation: Varies

Number of Visits: 2

Duration: 8 weeks

25 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial aims to help physicians with insomnia by using an online program called SHUTi. The program teaches better sleep habits through interactive lessons. By improving sleep, the trial hopes to enhance both sleep quality and mental health for physicians. SHUTi is an internet-based program for insomnia that has been developed and tested in various groups, showing significant improvements in sleep quality and reducing sleep problems.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Sleep Healthy Using the Internet (SHUT-i)?

Research shows that SHUT-i, an online program for treating insomnia, was rated as convenient, understandable, and useful by most users. Nearly all participants reported improvements in their sleep and quality of life, suggesting that SHUT-i can be an effective treatment for insomnia. ^{1 2 3 4 5}

Is the SHUTi program safe for humans?

The SHUTi program, an internet-based cognitive-behavioral therapy for insomnia, has been studied for its effectiveness, but specific safety data is not detailed in the available research. However, cognitive-behavioral therapy is generally considered safe for most people. ^{5 6 7 8 9}

How does the SHUT-i treatment differ from other treatments for sleep issues?

The SHUT-i treatment is unique because it uses an internet-based approach to improve sleep, focusing on reducing problematic internet use that negatively affects sleep quality. Unlike traditional treatments that might involve medication or in-person therapy, SHUT-i leverages online tools to address sleep issues related to excessive technology use. ^{10 11 12 13 14}

Research Team

Suzanne M Bertisch, MD, MPH

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

Inclusion Criteria

You have trouble sleeping and your ISI score is eight or higher.

Physician within the BWH Physician Organization

Able to give informed consent

Exclusion Criteria

Shift work >1 day/week over the treatment course

You have had a seizure in the last year.

Excessive daytime sleepiness (ESS≥16)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Self-service digital questionnaire

Treatment

Participants receive an evidence-based digital therapy to treat insomnia (SHUT-i)

8 weeks

Surveys at baseline and end of program

Follow-up

Participants are monitored for sleep and mental health outcomes post-treatment

8 weeks

Survey at 2-month follow-up

Treatment Details

Interventions

• Sleep Healthy Using the Internet (SHUT-i)

Participant Groups

Group I: Evidence-based digital therapy to treat insomnia Experimental Treatment 1 Intervention

Participants will be assigned an evidence-based digital therapy to treat insomnia (Sleep Healthy Using the Internet (SHUT-i)

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Findings from Research

Patients who received education on using sleep-enhancing tools (like eye masks and white noise machines) experienced a significant reduction in fatigue compared to those who only received general sleep information, indicating that targeted education can improve patient outcomes.

While the education intervention showed benefits in fatigue, it did not significantly affect other sleep-related issues or the length of hospital stay, suggesting that while helpful, the approach may need to be part of a broader strategy for improving overall patient well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Sleep Tool Education During Hospitalization: A Randomized Controlled Trial. Farrehi, PM., Clore, KR., Scott, JR., et al.[2019]

The SHUTi (Sleep Healthy Using The Internet) program, an interactive online intervention for insomnia, was rated highly by participants for its convenience and usefulness, with 95% reporting improvements in sleep and quality of life.

In a small sample of 21 participants, 90% perceived SHUTi as effective, suggesting that Internet-based cognitive-behavioral therapy could be a promising solution to address the lack of access to trained clinicians for insomnia treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Perceived Utility and Impact of an Internet Intervention for Insomnia. Thorndike, FP., Saylor, DK., Bailey, ET., et al.[2022]

In a study of 303 participants, an online cognitive behavioral therapy intervention for insomnia (SHUTi) significantly improved insomnia knowledge and reduced dysfunctional beliefs about sleep, which were linked to better long-term sleep outcomes after 12 months.

The changes in cognitive variables, such as insomnia knowledge and beliefs about sleep, were found to mediate the effectiveness of the SHUTi intervention, suggesting that addressing these cognitive factors is crucial for achieving lasting improvements in sleep quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive mechanisms of sleep outcomes in a randomized clinical trial of internet-based cognitive behavioral therapy for insomnia. Chow, PI., Ingersoll, KS., Thorndike, FP., et al.[2019]

The unguided Internet-based cognitive-behavioral treatment program for insomnia (SHUTi) significantly improved sleep outcomes in 181 participants over a nine-week period, outperforming a web-based patient education group.

Improvements in insomnia severity were maintained at a six-month follow-up for those who completed the SHUTi program, suggesting its potential as a first-line treatment option, although high dropout rates may affect the overall applicability of the results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Short-Term Efficacy of an Unguided Internet-Based Cognitive-Behavioral Therapy for Insomnia: A Randomized Controlled Trial With a Six-Month Nonrandomized Follow-Up. Hagatun, S., Vedaa, Ø., Nordgreen, T., et al.[2022]

Out of 2236 mobile health applications targeting insomnia, only 53 were evaluated, with most showing moderate quality; functionality was rated highest, indicating that while they may work well, their overall effectiveness varies significantly.

Only 19% of the apps had scientific evidence supporting their claims, highlighting a need for more rigorous studies and independent platforms to assess and inform users about the quality and content of these applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Help for insomnia from the app store? A standardized rating of mobile health applications claiming to target insomnia. Simon, L., Reimann, J., Steubl, LS., et al.[2023]

Implementing safe sleep practices can significantly lower the risk of sleep-related deaths in infants, highlighting the importance of proper sleeping environments.

Educating caregivers about safe sleep guidelines is crucial for enhancing infant safety during sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infant Safe Sleep Practices in the United States. Bombard, JM., Kortsmit, K., Cottengim, C., et al.[2021]

A literature review revealed that 90% of studies found a link between screen media use and both delayed bedtimes and reduced total sleep time in children and adolescents.

The widespread issue of sleep loss due to screen media has significant health implications, highlighting the need for further research to promote healthy sleep habits among youth and inform parents, teachers, and clinicians.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Youth Screen Media Habits and Sleep: Sleep-Friendly Screen Behavior Recommendations for Clinicians, Educators, and Parents. Hale, L., Kirschen, GW., LeBourgeois, MK., et al.[2019]

References

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

Efficacy of Sleep Tool Education During Hospitalization: A Randomized Controlled Trial. [2019]

2. Australia pubmed.ncbi.nlm.nih.gov

Development and Perceived Utility and Impact of an Internet Intervention for Insomnia. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Cognitive mechanisms of sleep outcomes in a randomized clinical trial of internet-based cognitive behavioral therapy for insomnia. [2019]

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

Efficacy of an Internet-based behavioral intervention for adults with insomnia. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The Short-Term Efficacy of an Unguided Internet-Based Cognitive-Behavioral Therapy for Insomnia: A Randomized Controlled Trial With a Six-Month Nonrandomized Follow-Up. [2022]

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

Help for insomnia from the app store? A standardized rating of mobile health applications claiming to target insomnia. [2023]

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

Infant Safe Sleep Practices in the United States. [2021]

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

Youth Screen Media Habits and Sleep: Sleep-Friendly Screen Behavior Recommendations for Clinicians, Educators, and Parents. [2019]

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

Development and dissemination of a consumer health information website on infant and toddler sleep. [2021]

10. Norway pubmed.ncbi.nlm.nih.gov

Television or unrestricted, unmonitored internet access in the bedroom and body mass index in youth athletes. [2018]

11. England pubmed.ncbi.nlm.nih.gov

Bedtime, shuteye time and electronic media: sleep displacement is a two-step process. [2021]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Exploring the Effects of Problematic Internet Use on Adolescent Sleep: A Systematic Review. [2023]

13. France pubmed.ncbi.nlm.nih.gov

"High sleepability without sleepiness". The ability to fall asleep rapidly without other signs of sleepiness. [2004]

14. Netherlands pubmed.ncbi.nlm.nih.gov

Neural basis underlying the relation between internet addiction tendency and sleep quality: The intrinsic default-mode network connectivity pathways. [2023]