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Circadian Rhythm Sleep-Wake Disorders, Shift Work TypeOSHINNCT05965609

Optimizing Sleep Health in Nurses

A study testing CBTI and MRTI in people with Circadian Rhythm Sleep-Wake Disorders, Shift Work Type and Sleep Initiation and Maintenance Disorders, run by Oregon State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The aim of the proposed study is to pilot test two behavioral sleep intervention strategies for improving insomnia among night shift working nurses. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
CBTI and MRTI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteUnited States
Study dates
8 Dec 2023to 3 Mar 2026
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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Current shift working nursing staff in Oregon
  • Expect to continue on shift work schedule during the study
  • Meets criteria for an insomnia disorder
  • Elevated insomnia symptoms
  • Have daily access to internet on a smartphone, tablet, or computer; and
  • Can read and write in English

Who cannot join

  • People with uncontrolled medical conditions
  • Presence of safety risk or condition in which study participation may be ineffective or result in increased risk to safety
  • Some current treatments for insomnia
  • Permanent day, evening, or rotating shift schedule
  • History of seizures or manic episode; or
  • Current/expected pregnancy during the study period

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Oregon State University

    Corvallis, Oregon, 97331

Other trials in United States

About this study

Official title: Piloting an Adaption of Cognitive Behavioral Therapy for Insomnia for Shift Workers (CBTI-Shift)

The aim of the proposed study is to pilot test two behavioral sleep intervention strategies for improving insomnia among night shift working nurses.

Read the detailed description

Night shift nurses with insomnia who meet all study criteria will receive one of two insomnia therapies. The specific therapy for insomnia will be determine by chance (like a flip of a coin), with an equal chance to receive either cognitive-behavioral therapy for insomnia or multicomponent relaxation therapy for insomnia, both modified for shift workers. Both therapies will be conducted over telehealth by interventionists trained in behavioral sleep medicine.

Being tested
CBTI, MRTI
Keywords
insomnia, shift work, circadian rhythm, sleep psychology, behavioral sleep medicine
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CBTIBehavioural

    Also called Cognitive Behavioral Therapy for Insomnia

    Intervention includes education about sleep and behavioral and cognitive strategies to improve sleep

  • MRTIBehavioural

    Also called Multicomponent Relaxation Therapy for Insomnia

    Intervention includes education about sleep and behavioral and relaxation strategies to improve sleep

Study groups in NCT05965609
Study groupRoleWhat they receive
CBTIOtherCognitive Behavioral Therapy for Insomnia
Receives: Behavioral: CBTI
MRTIOtherMulticomponent Relaxation Therapy for Insomnia
Receives: Behavioral: MRTI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Insomnia Severity Index

    Validated questionnaire; total score range between 0 and 28, with higher numbers representing greater insomnia severity

    Measured: At baseline and at the post-treatment assessment (occurring at approximately 10 weeks)

  2. Retention Rate

    Defined as [number of participants who complete minimal therapeutic dose (at least 4 sessions)] / [number of randomized participants in treatment arm]

    Measured: At the post-treatment assessment (occurring at approximately 10 weeks)

  3. Session Attendance

    For enrolled participants, attendance rates will be calculated as [number of visits attended] / [number of total visits]

    Measured: At the post-treatment assessment (occurring at approximately 10 weeks)

  4. Implementation Assessment Measure

    Validated questionnaire; total score range between 12 and 60, with higher numbers representing greater feasibility, acceptability, and appropriateness.

    Measured: At the post-treatment assessment (occurring at approximately 10 weeks)

Secondary outcomes (2)

  1. Change in Fatigue Severity Scale

    Validated questionnaire; total score range between 9 and 63, with higher numbers representing greater fatigue.

    Measured: At baseline and at the post-treatment assessment (occurring at approximately 10 weeks)

  2. Change in PROMIS Sleep Related Impairment 8 item

    Validated questionnaire; total score range between 8-40, with higher numbers indicating greater sleep-related wake time impairment

    Measured: At baseline and at the post-treatment assessment (occurring at approximately 10 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2023
  2. Study start8 Dec 2023
  3. Primary completion3 Mar 2026
  4. Study completion3 Mar 2026

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05965609
Sponsor's protocol ID
IRB-2021-1200
Acronym
OSHIN
Status last verified
Mar 2026
First submitted
12 Jul 2023
Last updated
6 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified data may be uploaded to a data repository to make it accessible for publication.

Publications

  • McMenamin TM. A time to work: recent trends in shift work and flexible schedules. Monthly Lab Rev. 2007;130:3.

  • Torquati L, Mielke GI, Brown WJ, Kolbe-Alexander T. Shift work and the risk of cardiovascular disease. A systematic review and meta-analysis including dose-response relationship. Scand J Work Environ Health. 2018 May 1;44(3):229-238. doi: 10.5271/sjweh.3700. Epub 2017 Dec 16.

    PubMed 29247501

  • Frost P, Kolstad HA, Bonde JP. Shift work and the risk of ischemic heart disease - a systematic review of the epidemiologic evidence. Scand J Work Environ Health. 2009 May;35(3):163-79. doi: 10.5271/sjweh.1319. Epub 2009 Apr 22.

    PubMed 19387517

  • Brown DL, Feskanich D, Sanchez BN, Rexrode KM, Schernhammer ES, Lisabeth LD. Rotating night shift work and the risk of ischemic stroke. Am J Epidemiol. 2009 Jun 1;169(11):1370-7. doi: 10.1093/aje/kwp056. Epub 2009 Apr 8.

    PubMed 19357324

  • Hansen J, Lassen CF. Nested case-control study of night shift work and breast cancer risk among women in the Danish military. Occup Environ Med. 2012 Aug;69(8):551-6. doi: 10.1136/oemed-2011-100240. Epub 2012 May 29.

    PubMed 22645325

  • Jia Y, Lu Y, Wu K, Lin Q, Shen W, Zhu M, Huang S, Chen J. Does night work increase the risk of breast cancer? A systematic review and meta-analysis of epidemiological studies. Cancer Epidemiol. 2013 Jun;37(3):197-206. doi: 10.1016/j.canep.2013.01.005. Epub 2013 Feb 9.

    PubMed 23403128

  • Rao D, Yu H, Bai Y, Zheng X, Xie L. Does night-shift work increase the risk of prostate cancer? a systematic review and meta-analysis. Onco Targets Ther. 2015 Oct 5;8:2817-26. doi: 10.2147/OTT.S89769. eCollection 2015.

    PubMed 26491356

  • Lin X, Chen W, Wei F, Ying M, Wei W, Xie X. Night-shift work increases morbidity of breast cancer and all-cause mortality: a meta-analysis of 16 prospective cohort studies. Sleep Med. 2015 Nov;16(11):1381-1387. doi: 10.1016/j.sleep.2015.02.543. Epub 2015 May 11.

    PubMed 26498240

  • Karlsson B, Knutsson A, Lindahl B. Is there an association between shift work and having a metabolic syndrome? Results from a population based study of 27,485 people. Occup Environ Med. 2001 Nov;58(11):747-52. doi: 10.1136/oem.58.11.747.

    PubMed 11600731

  • Gan Y, Yang C, Tong X, Sun H, Cong Y, Yin X, Li L, Cao S, Dong X, Gong Y, Shi O, Deng J, Bi H, Lu Z. Shift work and diabetes mellitus: a meta-analysis of observational studies. Occup Environ Med. 2015 Jan;72(1):72-8. doi: 10.1136/oemed-2014-102150. Epub 2014 Jul 16.

    PubMed 25030030

  • Barger LK, Lockley SW, Rajaratnam SM, Landrigan CP. Neurobehavioral, health, and safety consequences associated with shift work in safety-sensitive professions. Curr Neurol Neurosci Rep. 2009 Mar;9(2):155-64. doi: 10.1007/s11910-009-0024-7.

    PubMed 19268039

  • Johnson AL, Jung L, Song Y, Brown KC, Weaver MT, Richards KC. Sleep deprivation and error in nurses who work the night shift. J Nurs Adm. 2014 Jan;44(1):17-22. doi: 10.1097/NNA.0000000000000016.

    PubMed 24316614

  • Lee A, Myung SK, Cho JJ, Jung YJ, Yoon JL, Kim MY. Night Shift Work and Risk of Depression: Meta-analysis of Observational Studies. J Korean Med Sci. 2017 Jul;32(7):1091-1096. doi: 10.3346/jkms.2017.32.7.1091.

    PubMed 28581264

  • Angerer P, Schmook R, Elfantel I, Li J. Night Work and the Risk of Depression. Dtsch Arztebl Int. 2017 Jul 16;114(24):404-411. doi: 10.3238/arztebl.2017.0404.

    PubMed 28669378

  • Gu F, Han J, Laden F, Pan A, Caporaso NE, Stampfer MJ, Kawachi I, Rexrode KM, Willett WC, Hankinson SE, Speizer FE, Schernhammer ES. Total and cause-specific mortality of U.S. nurses working rotating night shifts. Am J Prev Med. 2015 Mar;48(3):241-52. doi: 10.1016/j.amepre.2014.10.018. Epub 2015 Jan 6.

    PubMed 25576495

Questions about this trial

What is this clinical trial studying?

A study testing CBTI and MRTI in people with Circadian Rhythm Sleep-Wake Disorders, Shift Work Type and Sleep Initiation and Maintenance Disorders, run by Oregon State University 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 6 inclusion and 6 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 6 Apr 2026. 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?

Change in Insomnia Severity Index (time frame: At baseline and at the post-treatment assessment (occurring at approximately 10 weeks)). The study lists 4 primary outcomes in all. 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 NCT05965609, which also lists 85 linked publications.

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 6 Apr 2026.

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