Oregon State University
Corvallis, Oregon, 97331-1102, United States
Location status: Recruiting
NCT Number: NCT06384742
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.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Corvallis, Oregon, 97331-1102, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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]
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]
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.
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
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.
Time frame: At the post-treatment assessment (occurring at approximately 12 weeks)
Self-rated adherence to recommendations (items added to standard sleep diary)
Time frame: After treatment is completed (occurring at approximately 12 weeks)
Enrollment percent, number of study assessment visits completed.
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
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.
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)
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)
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)
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)
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.
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.
Contact information is provided by the study sponsor or research team.
Jessica R Dietch, PhD
CONTACT
Liudmyla Kozii, MD, MPH
CONTACT
Oregon State University
Other
Developing a Sleep Health Intervention for Shift Workers
Acronym: SWISH
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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