Shift Worker Intervention for Sleep Health

NCT06384742 | Recruiting DMC

• 2 other identifiers: HE-2023-505K23HL157698
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Shift Work Type Circadian Rhythm Sleep Disorder; Insomnia, Psychophysiological

Keywords

insomnia; shift work; nurse; sleep psychology; behavioral sleep medicine; circadian rhythm

Outcome Measures

Primary Outcomes (3)

• Retention Rate

  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

  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

  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 Outcomes (12)

• Change in PROMIS Sleep Related Impairment

  At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)

• Change in PROMIS Sleep Disturbances

  At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)

• Patient Adherence

  At the post-treatment assessment (occurring at approximately 12 weeks)

• Acceptability of Study Procedures and SWISH

  After treatment is completed (occurring at approximately 12 weeks)

• Change in Fatigue Severity Scale

  At baseline and the post-treatment assessment (occurring at approximately 12 weeks)

Study Arms (2)

SWISH

EXPERIMENTAL

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

WLC

NO INTERVENTION

Waitlist Control: Participants in the delayed treatment control condition will begin the SWISH intervention following completion of the posttreatment time point.

Interventions

Shift Worker Intervention for Sleep Health BEHAVIORAL

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

Also known as: SWISH

SWISH

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)"

Sponsors & Collaborators

• Oregon State University: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Oregon State University

Corvallis, Oregon, 97331-1102, United States

RECRUITING

Related Publications (84)

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• Tremaine R, Dorrian J, Lack L, Lovato N, Ferguson S, Zhou X, Roach G. The relationship between subjective and objective sleepiness and performance during a simulated night-shift with a nap countermeasure. Appl Ergon. 2010 Dec;42(1):52-61. doi: 10.1016/j.apergo.2010.04.005. Epub 2010 May 14.

  PMID: 20471003 BACKGROUND

• Bonnefond A, Muzet A, Winter-Dill AS, Bailloeuil C, Bitouze F, Bonneau A. Innovative working schedule: introducing one short nap during the night shift. Ergonomics. 2001 Aug 15;44(10):937-45. doi: 10.1080/00140130110061138.

  PMID: 11681794 BACKGROUND

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Jessica Dietch, PhD

  Oregon State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jessica R Dietch, PhD

CONTACT

5417371358; jessee.dietch@oregonstate.edu

Liudmyla Kozii, MD, MPH

CONTACT

koziil@oregonstate.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants are asked to refrain from mentioning any information about the treatment they receive when interacting with the investigator or outcomes assessors. Participants are asked not to share details of their treatment with other individuals at their workplace.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 25, 2024
• Study Start: April 28, 2025
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): January 15, 2028
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• 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.
• 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.

Locations

US (1)