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NCT Number: NCT06384742

Shift Worker Intervention for Sleep Health

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oregon State University

Corvallis, Oregon, 97331-1102, United States

Location status: Recruiting

Location contact

Jessee Dietch, PhD

CONTACT

[email protected]

541-737-1358

Jessee Dietch, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)"

Treatment and study plan

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

Other names: SWISH

Primary outcomes

  1. 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]

  2. 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]

  3. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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)

  4. 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.

  5. 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

  6. 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.

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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.

  12. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jessica R Dietch, PhD

CONTACT

[email protected]

5417371358

Liudmyla Kozii, MD, MPH

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Oregon State University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Developing a Sleep Health Intervention for Shift Workers

Acronym: SWISH

Important dates

Study start
2025
Primary completion
2027
Study completion
2028
First posted
Apr 25, 2024
Registry last updated
May 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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