Shift Worker Intervention for Sleep Health
- Conditions
- Shift Work Type Circadian Rhythm Sleep DisorderInsomnia, Psychophysiological
- Interventions
- Behavioral: Shift Worker Intervention for Sleep Health
- Registration Number
- NCT06384742
- Lead Sponsor
- Oregon State University
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description SWISH Shift Worker Intervention for Sleep Health SWISH, a multicomponent behavioral intervention based on cognitive behavioral therapy for insomnia. Other Names: Cognitive Behavioral Therapy for Insomnia
- Primary Outcome Measures
Name Time Method Retention Rate At the post-treatment assessment (occurring at approximately 12 weeks) Defined as \[number of participants who complete minimal therapeutic dose (at least 4 sessions)\] / \[number of randomized participants in treatment arm\]
Session Attendance At the post-treatment assessment (occurring at approximately 12 weeks) For enrolled participants, attendance rates will be calculated as \[number of visits attended\] / \[number of total visits\]
Implementation Assessment Measure 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 Outcome Measures
Name Time Method Change in PROMIS Sleep Related Impairment 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
Change in PROMIS Sleep Disturbances 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.
Patient Adherence At the post-treatment assessment (occurring at approximately 12 weeks) Self-rated adherence to recommendations (items added to standard sleep diary)
Acceptability of Study Procedures and SWISH After treatment is completed (occurring at approximately 12 weeks) Enrollment percent, number of study assessment visits completed.
Change in Fatigue Severity Scale 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
Change in Epworth Sleepiness Scale 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.
Change in sleep efficiency on modified Consensus Sleep Diary 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)
Change in sleep duration on modified Consensus Sleep Diary 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)
Change in actigraphy-derived sleep efficiency 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)
Change in actigraphy-derived sleep duration 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)
Change in PROMIS Emotional Distress - Depression 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.
Change in cognition 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.
Trial Locations
- Locations (1)
Oregon State University
🇺🇸Corvallis, Oregon, United States