Sleep Well: Digital Insomnia Treatment Program For Physicians

NCT ID: NCT05289596

Last Updated: 2023-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-04
• Study Completion Date: 2022-07-31

Brief Summary

Sleep disturbance is risk factor for incident depression and remains a leading concern for physician burnout; as sleep plays a fundamental role in mood, stress, and cognition, including medical errors. The goal of this project is to implement an evidence-based digital therapy to treat insomnia (Sleep Healthy Using the Internet (SHUTi) for physicians to improve both sleep and mental health outcomes. The investigators will evaluate both process and individual-outcome metrics to define success. Individual level outcomes will be assessed pre-program (at start of participation), week 8 (end-program), and week 16 (2-month follow-up). This information will enable us to design larger future implementation initiatives for the healthy sleep program across the hospital, should the pilot be successful.

Detailed Description

The goal of this project is to implement an evidence-based digital therapy to treat insomnia (Sleep Healthy Using the Internet (shut-i) for physicians to improve both sleep and mental health outcomes. The investigators will evaluate both process and individual-outcome metrics to define success. This information will enable us to design larger future implementation initiatives for the healthy sleep program across the hospital, should the pilot be successful. The investigators plan to enroll 25 physicians who screen positive for insomnia (ISI >7). Interested potential participants will complete a preliminary screening to assess eligibility. Refusal rates and eligibility status will be tracked for recruitment yields.

Recruitment will be done via hospital newsletters, information boards, emails, and faculty meetings. Screening will be done through self-service digital questionnaire. Eligible participants will review an e-consent factsheet (REDCap).

Those who enroll will complete surveys at baseline (pre-program), week 8 (end of program), and week 16 (2-month follow-up) securely via REDCap. In addition, feasibility and acceptability data based on the RE-AIM framework and a sub-sample of participants will be invited to an optional intervention feedback interview.

The investigators will evaluate the feasibility and acceptability of recruiting from our target population, delivering our intervention with high adherence and fidelity, and estimating effect sizes of our patient-reported outcomes, including sleep duration, quality, mood, and burnout. Assessment criteria will be based on the RE-AIM model for program evaluation (reach, effectiveness, adoption, implementation, maintenance).

It will be the responsibility of the PI to oversee the safety of the study. The PI will follow the Partners' policy Reporting Unanticipated Problems including Adverse Events (Rev. 9/24/2014) and will promptly report problems to the PHRC.

Conditions

Sleep Disturbance; Insomnia; Stress, Psychological; Anxiety; Burnout, Professional

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Evidence-based digital therapy to treat insomnia

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

Group Type: EXPERIMENTAL

Sleep Healthy Using the Internet (SHUT-i)

Intervention Type: BEHAVIORAL

SHUTi is a six session, 6-8 week cognitive behavioral therapy for insomnia program over the internet. The online, self-paced program offers illustrations, graphics, videos and built-in algorithms offering brief sleep diaries, personalized sleep window recommendations, education from sleep experts, peer stories about insomnia, and skills to help participants relearn proper sleep dynamics and increase sleep efficiency.

Interventions

Sleep Healthy Using the Internet (SHUT-i)

SHUTi is a six session, 6-8 week cognitive behavioral therapy for insomnia program over the internet. The online, self-paced program offers illustrations, graphics, videos and built-in algorithms offering brief sleep diaries, personalized sleep window recommendations, education from sleep experts, peer stories about insomnia, and skills to help participants relearn proper sleep dynamics and increase sleep efficiency.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Have a digital device with reliable internet access
• Physician within the BWH Physician Organization
• Insomnia Severity Index (ISI) score ≥8
• Able to give informed consent

Exclusion Criteria

• Shift work >1 day/week over the treatment course
• Excessive daytime sleepiness (ESS≥16)
• History of bipolar disorder
• History of seizure within the past year

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Suzanne M. Bertisch, MD, MPH

Associate Physician and Clinical Director of Behavioral Sleep Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Suzanne M Bertisch, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

References

Benge E, Lauffenburger JC, Reid M, Rottapel R, Mehta D, Bertisch SM. Leveraging digital therapeutics to improve physician sleep: a pilot implementation study. J Clin Sleep Med. 2025 Jul 1;21(7):1297-1299. doi: 10.5664/jcsm.11666.

Reference Type: DERIVED

PMID: 40114469 (View on PubMed)

Other Identifiers

2021P000927

Identifier Type: -

Identifier Source: org_study_id