Clinical trial NCT05289596: Sleep Well: Digital Insomnia Treatment Program For Physicians
Official title: Pilot Study: Sleep Well: Implementing an Evidence-Based Digital Insomnia Treatment Program For Physicians
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep Disturbance
Insomnia
Stress, Psychological
Anxiety
Burnout, Professional
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2022-03-21
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance, 8b
timeFrame: 10 weeks
Secondary outcomes:
measure: PROMIS Sleep Impairment, 8a
timeFrame: 10 weeks
measure: Insomnia Severity Index, ISI
timeFrame: 10 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Suzanne M Bertisch, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: