Insomnia, Psychophysiological, Shift Work Type Circadian Rhythm Sleep Disorder
Conditions
Keywords
insomnia, shift work, nurse, sleep psychology, behavioral sleep medicine, circadian rhythm
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.
Interventions
BEHAVIORALShift Worker Intervention for Sleep Health
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
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Oregon State University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Participants are asked to refrain from mentioning any information about the treatment they receive when interacting with the investigator or outcomes assessors. Participants are asked not to share details of their treatment with other individuals at their workplace.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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. |
| 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 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) |
Countries
United States
Contacts
Primary ContactJessica R Dietch, PhD
Backup ContactLiudmyla Kozii, MD, MPH
Outcome results
None listed