Sleep Well: Digital Insomnia Treatment Program For Physicians

Anxiety Clinical Trial

Official title: Pilot Study: Sleep Well: Implementing an Evidence-Based Digital Insomnia Treatment Program For Physicians

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Anxiety
• Burnout, Professional
• Dyssomnias
• Insomnia
• Parasomnias
• Sleep Disturbance
• Sleep Initiation and Maintenance Disorders
• Stress, Psychological

• NCT number: NCT05289596
• Study type: Interventional
• Source: Brigham and Women's Hospital
• Status: Completed
• Phase: N/A
• Start date: February 4, 2022
• Completion date: July 31, 2022