Shift Worker Intervention for Sleep Health

Shift Work Type Circadian Rhythm Sleep Disorder Clinical Trial

— SWISH  

Official title:

Developing a Sleep Health Intervention for Shift Workers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06384742
• Other study ID #: K23HL157698
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2024
• Est. completion date: March 2027

Study information

• Verified date: April 2024
• Source: Oregon State University
• Contact: Jessica R Dietch, PhD
• Phone: 5417371358
• Email: jessee.dietch[@]oregonstate.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 2027
• Est. primary completion date: September 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Provision of signed and dated informed consent form

• Any gender; Ages 18-65

• Currently employed as a nurse in the state of Oregon

• Currently have shift work schedules (i.e., stable night shift or rotating shifts that include nights, >=3 nights/week) and have worked shift work >=3 nights/week for at least 3 months

• Expect to have a shift work schedule >=3 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)"

Related Conditions & MeSH terms

• Insomnia, Psychophysiological
• Shift Work Type Circadian Rhythm Sleep Disorder
• Sleep Disorders, Circadian Rhythm
• Sleep Initiation and Maintenance Disorders
• Sleep Wake Disorders

Intervention

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 seven approximately weekly sessions that range in length from 30-60 minutes

Locations

Country	Name	City	State
United States	Oregon State University	Corvallis	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon State University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

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* Note: There are 85 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 10 weeks)
Primary	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 10 weeks)
Primary	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 10 weeks)
Secondary	Patient Adherence	be assessed by examining light exposure (from actigraphy), sleep timing relative to recommendations (sleep diary, actigraphy), and self-rated adherence to recommendations (items added to standard sleep diary)	At the post-treatment assessment (occurring at approximately 10 weeks)
Secondary	Therapist Fidelity	Therapist fidelity to the intervention components will be assessed with a treatment component checklist which is derived specifically for SWISH. This instrument consists of items corresponding to therapist verbal instruction or action that should occur for a given intervention component. The % of completed items will be computed for each session.	At the post-treatment assessment (occurring at approximately 10 weeks)
Secondary	Acceptability of Study Procedures and SWISH	Enrollment %, number of study assessment visits completed, and therapist-rated usability of treatment materials will be calculated and summarized.	After treatment is completed (occurring at approximately 10 weeks)
Secondary	Mean 24-hour sleep duration and efficiency	Mean 24-hour subjective sleep duration and efficiency will be assessed using the Consensus Sleep Diary and actigraphy. Sleep diary is a daily, prospective self-report measure that provides subjective estimates of sleep parameters. Actigraphy is a wrist-worn, wristwatch-like devices that assesses movement as a proxy for sleep and wake patterning.	At baseline and the post-treatment assessment (occurring at approximately 10 weeks)
Secondary	Change in Fatigue Severity Scale	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 10 weeks)
Secondary	Change in Epworth Sleepiness Scale	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 10 weeks)
Secondary	Executive functioning	assessed with the Joggle Research Battery, a brief iPad interactive cognitive testing battery which tracks cognitive functioning domains using a series of eight tasks. Executive functioning domains of interest are directly relevant to work performance and include risk decision making, vigilant attention, working memory, and visual learning.	At baseline and the post-treatment assessment (occurring at approximately 10 weeks)
Secondary	PROMIS Sleep Related Impairment	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 10 weeks)
Secondary	PROMIS Sleep Disturbances	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 10 weeks)