Shift Worker Intervention for Sleep Health (SWISH)

April 29, 2025 updated by: Jessee Dietch, Oregon State University

Developing a Sleep Health Intervention for Shift Workers

The aim of this study is to pilot test a comprehensive, personalized, media-augmented telehealth intervention ("SWISH") designed to improve sleep health among shift workers.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Night shift nurses with insomnia who meet all study criteria will receive insomnia therapy, modified for shift workers that is designed to improve sleep health among shift workers by targeting shift workers' unique sleep health problems which manifest during both sleep and wake. Participants will be randomized to either SWISH, a multicomponent behavioral intervention based on cognitive behavioral therapy for insomnia that is individually administered via telehealth across approximately weekly sessions that range in length from 30-60 minutes, or delayed treatment control, which will involve weekly assessments but no active treatment until the delay period is over, at which point they will be offered the intervention. The therapy will be conducted over telehealth by interventionists trained in behavioral sleep medicine.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Oregon
      • Corvallis, Oregon, United States, 97331-1102
        • Recruiting
        • Oregon State University
        • Contact:
        • Principal Investigator:
          • Jessee Dietch, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Provision of signed and dated informed consent form
  • Any gender; Ages 18-65
  • Currently employed as a nurse or nursing staff member (e.g., CNA) in the United States
  • Currently have shift work schedules (i.e., stable night shift or rotating shifts that include nights, >=2 nights/week) and have worked shift work >=2 nights/week for at least 3 months
  • Expect to have a shift work schedule >=2 nights/week over the next 6 months
  • endorse poor sleep, as evidenced by T-score >=60 on the PROMIS Sleep Disturbance OR Sleep-Related Impairment measure
  • Have daily access to the internet on a smartphone, table, or computer; and
  • Can read and write in English.

Exclusion Criteria:

  • Conditions which make study treatment likely to be ineffective. For example, current chronic use of medications that interfere with sleep, alcohol or substance use disorder, or thought disorder (as determined by DIAMOND psychiatric interview), unstable sleep or medical conditions that necessitate additional medical care not provided by study treatments (e.g., known untreated sleep apnea).
  • Presence of safety risk or condition in which study participation may result in increased risk to safety (e.g., elevated risk for suicide, self-reported uncontrolled seizure disorder, history of manic or hypomanic episode, current pregnancy),
  • Currently receiving non-pharmacological treatment for insomnia (e.g., cognitive behavioral therapy for insomnia) and/or current unstable hypnotic/alerting medication use OR
  • Currently participating in other research studies with substantial overlap in terms of methods/procedures (e.g., PI's ongoing study "Piloting an Adaptation of Cognitive Behavioral Therapy for Insomnia for Shift Workers (CBTI-Shift)"

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SWISH

SWISH, a multicomponent behavioral intervention based on cognitive behavioral therapy for insomnia.

Other Names:

Cognitive Behavioral Therapy for Insomnia
Behavioral: Shift Worker Intervention for Sleep Health
SWISH, a multicomponent behavioral intervention based on cognitive behavioral therapy for insomnia that is individually administered via telehealth across nine approximately weekly sessions that range in length from 15-60 minutes
Other Names:
  • SWISH
No Intervention: WLC
Waitlist Control: Participants in the delayed treatment control condition will begin the SWISH intervention following completion of the posttreatment time point.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retention Rate
Time Frame: At the post-treatment assessment (occurring at approximately 12 weeks)
Defined as [number of participants who complete minimal therapeutic dose (at least 4 sessions)] / [number of randomized participants in treatment arm]
At the post-treatment assessment (occurring at approximately 12 weeks)
Session Attendance
Time Frame: At the post-treatment assessment (occurring at approximately 12 weeks)
For enrolled participants, attendance rates will be calculated as [number of visits attended] / [number of total visits]
At the post-treatment assessment (occurring at approximately 12 weeks)
Implementation Assessment Measure
Time Frame: At the post-treatment assessment (occurring at approximately 12 weeks)
Validated questionnaire; total score range between 12 and 60, with higher numbers representing greater feasibility, acceptability, and appropriateness.
At the post-treatment assessment (occurring at approximately 12 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Adherence
Time Frame: At the post-treatment assessment (occurring at approximately 12 weeks)
Self-rated adherence to recommendations (items added to standard sleep diary)
At the post-treatment assessment (occurring at approximately 12 weeks)
Change in Fatigue Severity Scale
Time Frame: At baseline and the post-treatment assessment (occurring at approximately 12 weeks)
Validated questionnaire; total score range between 9 and 63, with higher numbers representing greater fatigue
At baseline and the post-treatment assessment (occurring at approximately 12 weeks)
Change in Epworth Sleepiness Scale
Time Frame: At baseline and the post-treatment assessment (occurring at approximately 12 weeks)
The Epworth Sleepiness Scale is a validated 8-item self-report measure used to assess sleepiness during waking hours, with higher numbers representing greater sleepiness.
At baseline and the post-treatment assessment (occurring at approximately 12 weeks)
Change in PROMIS Sleep Related Impairment
Time Frame: At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)
A validated 8-item Common Data Element measures which assess sleep health broadly as manifested during wake. Validated questionnaire; total score range between 8-40, with higher numbers indicating greater sleep-related wake time impairment
At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)
Change in PROMIS Sleep Disturbances
Time Frame: At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)
A validated 8-item Common Data Element measures which assess sleep health broadly as manifested during sleep. Validated questionnaire; total score range between 8-40, with higher numbers indicating greater sleep disturbances.
At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)
Change in sleep duration on modified Consensus Sleep Diary
Time Frame: At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)
Sleep duration in hours will be derived from modified version of the Consensus Sleep Diary; averaged across available days at each time point (up to 2 weeks)
At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)
Change in actigraphy-derived sleep duration
Time Frame: At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)
Hours of sleep duration will be derived from Fitbit Sense and averaged across available days at each time point (up to 2 weeks)
At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)
Change in PROMIS Emotional Distress - Depression
Time Frame: At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)
A validated 8-item Common Data Element measures which assess depressive symptom severity. Validated questionnaire; total raw score range between 8-40, with higher numbers indicating greater depressive symptomatology.
At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)
Change in cognition
Time Frame: At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)
Cognitive performance on the Joggle Research Cognitive Battery selected subtests including Psychomotor Vigilance Task (PVT). T scores (higher is better) will be reported.
At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)
Acceptability of Study Procedures and SWISH
Time Frame: After treatment is completed (occurring at approximately 12 weeks)
Enrollment percent, number of study assessment visits completed.
After treatment is completed (occurring at approximately 12 weeks)
Change in sleep efficiency on modified Consensus Sleep Diary
Time Frame: At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)
Sleep efficiency percent will be derived from modified version of the Consensus Sleep Diary; averaged across available days at each time point (up to 2 weeks)
At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)
Change in actigraphy-derived sleep efficiency
Time Frame: At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)
Sleep efficiency percent will be derived from Fitbit Sense and averaged across available days at each time point (up to 2 weeks)
At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Oregon State University

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Jessica Dietch, PhD, Oregon State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2025

Primary Completion (Estimated)

September 30, 2027

Study Completion (Estimated)

January 15, 2028

Study Registration Dates

First Submitted

April 22, 2024

First Submitted That Met QC Criteria

April 22, 2024

First Posted (Actual)

April 25, 2024

Study Record Updates

Last Update Posted (Actual)

May 2, 2025

Last Update Submitted That Met QC Criteria

April 29, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE-2023-505
  • K23HL157698 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified data may be uploaded to a data repository to make it accessible for publication.

IPD Sharing Time Frame

Data will become available within 2 years after the publication of the results pertaining to the primary aims and will be available for at least 2 years.

IPD Sharing Access Criteria

Data will be shared only with investigators who have a clear and rigorous analytic plan and who sign a data use agreement with the principal investigator.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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