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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
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
Oregon State University
Corvallis, Oregon, United States
RECRUITINGRetention Rate
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)
Session Attendance
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)
Implementation Assessment Measure
Validated questionnaire; total score range between 12 and 60, with higher numbers representing greater feasibility, acceptability, and appropriateness.
Time frame: At the post-treatment assessment (occurring at approximately 12 weeks)
Change in 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
Time frame: At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)
Change in 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.
Time frame: At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)
Patient Adherence
Self-rated adherence to recommendations (items added to standard sleep diary)
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Time frame: At the post-treatment assessment (occurring at approximately 12 weeks)
Acceptability of Study Procedures and SWISH
Enrollment percent, number of study assessment visits completed.
Time frame: After treatment is completed (occurring at approximately 12 weeks)
Change in Fatigue Severity Scale
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)
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.
Time frame: At baseline and the post-treatment assessment (occurring at approximately 12 weeks)
Change in sleep efficiency on modified Consensus Sleep Diary
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)
Change in sleep duration on modified Consensus Sleep Diary
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)
Change in actigraphy-derived sleep efficiency
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)
Change in actigraphy-derived sleep duration
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)
Change in PROMIS Emotional Distress - Depression
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)
Change in cognition
Cognitive performance on the Joggle Research Cognitive Battery selected subtests including Psychomotor Vigilance Task (PVT). T scores (higher is better) will be reported.
Time frame: At baseline and at the post-treatment assessment (occurring at approximately 12 weeks)