Sleep Well: Digital Insomnia Treatment Program For Physicians

Not Applicable

Completed

• Conditions: Stress, Psychological; Anxiety; Burnout, Professional; Sleep Disturbance; Insomnia
• Interventions: Behavioral: Sleep Healthy Using the Internet (SHUT-i)

• Registration Number: NCT05289596
• Lead Sponsor: Brigham and Women's Hospital

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.

Study Timeline

• Study Start: 2022-02-04
• Study First Submitted: 2022-02-28
• Study First Submitted QC: 2022-03-11
• Study First Posted: 2022-03-21
• Primary Completion: 2022-07-31
• Study Completion: 2022-07-31
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-26
• Last Update Posted: 2023-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance, 8b	10 weeks	PROMIS Sleep Disturbance measures self-reported sleep quality and associated daytime functioning during the past seven days. The measure includes 8-items with higher scores indicating greater sleep disturbance. The minimum score is 8 and the maximum score is 40. Item responses are combined to yield a T-score with a population mean of 50 and standard deviation of 10.

Secondary Outcome Measures

Name	Time	Method
Insomnia Severity Index, ISI	10 weeks	The Insomnia Severity Index is a 7-item self-report questionnaire assessing the nature, severity, and impact of insomnia in the last month. A 5-point Likert scale is used to rate each item (e.g., 0 = no problem; 4 = very severe problem), yielding a total score ranging from 0 to 28. The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).
PROMIS Sleep Impairment, 8a	10 weeks	PROMIS Sleep Impairment measures self-reported perceptions of alertness, sleepiness, and tiredness during usual waking hours, and the perceived functional impairments during wakefulness associated with sleep problems or impaired alertness during the past seven days. The measure includes 8-items with higher scores indicating greater sleep impairment. The minimum score is 8 and the maximum score 40. Item responses are combined to yield a T-score with a population mean of 50 and standard deviation of 10.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States