NCT05289596

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 4, 2022

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2022

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 21, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

July 28, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

February 28, 2022

Last Update Submit

July 26, 2023

Conditions

Sleep DisturbanceInsomniaStress, PsychologicalAnxietyBurnout, Professional

Outcome Measures

Primary Outcomes (1)

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

    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.

    10 weeks

Secondary Outcomes (2)

  • PROMIS Sleep Impairment, 8a

    10 weeks

  • Insomnia Severity Index, ISI

    10 weeks

Study Arms (1)

Evidence-based digital therapy to treat insomnia

EXPERIMENTAL

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

Behavioral: Sleep Healthy Using the Internet (SHUT-i)

Interventions

Sleep Healthy Using the Internet (SHUT-i)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.

Evidence-based digital therapy to treat insomnia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

  • 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.

    PMID: 40114469DERIVED

MeSH Terms

Conditions

ParasomniasSleep Initiation and Maintenance DisordersStress, PsychologicalAnxiety DisordersBurnout, Professional

Condition Hierarchy (Ancestors)

Sleep Wake DisordersNervous System DiseasesMental DisordersSleep Disorders, IntrinsicDyssomniasBehavioral SymptomsBehaviorOccupational StressOccupational DiseasesBurnout, Psychological

Study Officials

  • Suzanne M Bertisch, MD, MPH

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Physician and Clinical Director of Behavioral Sleep Medicine

Study Record Dates

First Submitted

February 28, 2022

First Posted

March 21, 2022

Study Start

February 4, 2022

Primary Completion

July 31, 2022

Study Completion

July 31, 2022

Last Updated

July 28, 2023

Record last verified: 2023-07

Locations

US(1)