Sleep DisturbanceNCT05289596
Sleep Well: Digital Insomnia Treatment Program For Physicians
A study testing Sleep Healthy Using the Internet (SHUT-i) in people with Sleep Disturbance and Insomnia, run by Brigham and Women's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Disturbance, Insomnia, Stress, Psychological
- What is being tested?
- Sleep Healthy Using the Internet (SHUT-i)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2022to 31 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Pilot Study: Sleep Well: Implementing an Evidence-Based Digital Insomnia Treatment Program For Physicians
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.
Read the 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.
- Being tested
- Sleep Healthy Using the Internet (SHUT-i)
- Medical subject headings
- Parasomnias, Sleep Initiation and Maintenance Disorders, Stress, Psychological, Anxiety Disorders, Burnout, Professional
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleep Healthy Using the Internet (SHUT-i)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Behavioral: Sleep Healthy Using the Internet (SHUT-i) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 weeks
Secondary outcomes (2)
PROMIS Sleep Impairment, 8a
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.
Measured: 10 weeks
Insomnia Severity Index, ISI
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).
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start4 Feb 2022
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep DisturbanceStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suzanne M. Bertisch, MD, MPH, Brigham and Women's Hospital
- Investigators
- Suzanne M Bertisch, MD, MPH, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289596
- Sponsor's protocol ID
- 2021P000927
- Status last verified
- Jul 2023
- First submitted
- 28 Feb 2022
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40114469
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study: Sleep Well: Implementing an Evidence-Based Digital Insomnia Treatment Program For Physicians
- ClinicalTrials.gov ID
- NCT05289596
- Acronym / sponsor ID
- 2021P000927
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 4 Feb 2022 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 21 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evidence-based digital therapy to treat insomnia | Experimental | Behavioral: 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sleep Healthy Using the Internet (SHUT-i)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. | Behavioural | Evidence-based digital therapy to treat insomnia |
Primary outcome
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance, 8b
Time frame: 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.
2 secondary outcomes
PROMIS Sleep Impairment, 8a
Time frame: 10 weeks
Insomnia Severity Index, ISI
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Derived from this study: PubMed 40114469Benge 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne M Bertisch, MD, MPH principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sleep Healthy Using the Internet (SHUT-i) in people with Sleep Disturbance and Insomnia, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance, 8b (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05289596, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2023.