Shift Worker Intervention for Sleep Health

NCT ID: NCT06384742

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-28
• Study Completion Date: 2028-01-15

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.

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.

Conditions

Shift Work Type Circadian Rhythm Sleep Disorder; Insomnia, Psychophysiological

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SWISH

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

Other Names:

Cognitive Behavioral Therapy for Insomnia

Group Type: EXPERIMENTAL

Shift Worker Intervention for Sleep Health

Intervention Type: 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

WLC

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: BEHAVIORAL

Other Intervention Names

SWISH

Eligibility Criteria

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)"

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

Oregon State University

OTHER

Sponsor Role: lead

Responsible Party

Jessee Dietch

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jessica Dietch, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon State University

Locations

Oregon State University

Corvallis, Oregon, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jessica R Dietch, PhD

Role: CONTACT

jessee.dietch@oregonstate.edu

5417371358

Liudmyla Kozii, MD, MPH

Role: CONTACT

koziil@oregonstate.edu

Facility Contacts

Jessee Dietch, PhD

Role: primary

jessee.dietch@oregonstate.edu

541-737-1358

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Other Identifiers

K23HL157698

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HE-2023-505

Identifier Type: -

Identifier Source: org_study_id