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临床试验/NCT05289596
NCT05289596已完成不适用

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

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2022年2月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance, 8b

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance, 8b

时间窗: 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.

次要结局

  • Insomnia Severity Index, ISI(10 weeks)
  • PROMIS Sleep Impairment, 8a(10 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Suzanne M. Bertisch, MD, MPH

Associate Physician and Clinical Director of Behavioral Sleep Medicine

Brigham and Women's Hospital

研究点 (2)

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