Digital Program for Insomnia

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a digital therapy called SHUTi (Sleep Healthy Using the Internet), designed to assist physicians with insomnia. The main goal is to determine if this online treatment can improve sleep and mental health, potentially reducing burnout and errors at work. Physicians from the BWH Physician Organization who experience sleep difficulties and have internet access are ideal candidates. Researchers will measure outcomes before, during, and after the program, aiming to develop a larger sleep program for hospitals if this trial succeeds. As an unphased trial, this study offers physicians the chance to contribute to innovative research that could enhance sleep health solutions in hospitals.

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 prior data suggests that this digital therapy is safe for treating insomnia?

Research shows that the Sleep Healthy Using the Internet (SHUT-i) program is generally easy for users to handle. Previous studies found that participants improved their sleep by falling asleep faster, sleeping more deeply, and waking up refreshed.

These studies mainly assessed the program's effectiveness, but they also suggest that SHUT-i is safe, as no major negative effects were reported. This is encouraging for anyone considering joining a trial to try this online therapy for insomnia.

In short, the evidence suggests that SHUT-i is a safe choice that can help improve sleep without causing significant side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about SHUT-i because it offers a digital, evidence-based approach to treating insomnia, which is especially convenient for busy physicians. Unlike traditional insomnia treatments that often involve medication or in-person therapy, SHUT-i delivers cognitive behavioral therapy for insomnia (CBT-I) through an online platform. This means it can be accessed anytime, anywhere, making it a flexible and accessible option. Additionally, SHUT-i helps users develop healthier sleep habits without the potential side effects of medication, providing a non-invasive and sustainable solution.

What evidence suggests that this digital therapy is effective for treating insomnia?

Research has shown that the Sleep Healthy Using the Internet (SHUT-i) program, which participants in this trial will receive, effectively treats insomnia. Studies have found that it improves sleep efficiency, meaning participants spend more time actually sleeping while in bed. Participants also reported feeling more refreshed upon waking. Additionally, SHUT-i helps users fall asleep faster and reduces the severity of insomnia. This online therapy uses web-based sleep diaries and personalized feedback to guide users, demonstrating strong results in improving sleep for those with insomnia. Overall, SHUT-i shows promise in enhancing sleep and related mental health outcomes. ^{1 2 3 4 6}

Who Is on the Research Team?

Suzanne M Bertisch, MD, MPH

Principal Investigator

Brigham and Women's Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Sleep Healthy Using the Internet (SHUT-i)

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. ebccp.cancercontrol.cancer.gov ebccp.cancercontrol.cancer.gov/programDetails.do?programId=2678268

Sleep Healthy Using the Internet (SHUTi) The study showed increases in sleep efficiency, soundness of sleep, and feeling refreshed upon awakening and decreases in sleep onset latency, insomnia severity ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10709797/

Efficacy of an Internet-Delivered Intervention for Improving ... The SHUTi program relies on user-entered web-based sleep diaries to track progress and tailor treatment recommendations. Automated emails are sent throughout ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03213132

Sleep Healthy Using The Internet for Older Adult Sufferers ... This study will compare the efficacy of an interactive internet intervention for older adults with insomnia called SHUTi OASIS (Sleep Healthy Using the ...

4. nature.com nature.com/articles/s41746-025-01847-0

A randomized controlled trial of a digital cognitive ... This study evaluated the efficacy of Sleep Healthy Using the Internet for Older Adults Suffering with Insomnia and Sleeplessness (SHUTi OASIS),

5. sciencedirect.com sciencedirect.com/science/article/pii/S0005796722000559

Real-world evidence from users of a behavioral digital ... Findings presented here focus on outcome and patient engagement data of SHUTi (Sleep Health Using the Internet), a digital therapeutic delivering Cognitive ...

6. jamanetwork.com jamanetwork.com/journals/jamapsychiatry/fullarticle/483124

Efficacy of an Internet-Based Behavioral Intervention for ... This Internet program, SHUTi (Sleep Healthy Using the Internet, http://www.shuti.net), incorporates the primary treatment components of CBT for insomnia, ...