Developing a Sleep Health Intervention for Shift Workers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Shift Work Type Circadian Rhythm Sleep Disorder
- Sponsor
- Oregon State University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Retention Rate
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Jessee Dietch
Principal Investigator
Oregon State University
Eligibility Criteria
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)"
Outcomes
Primary Outcomes
Retention Rate
Time Frame: At the post-treatment assessment (occurring at approximately 12 weeks)
Defined as \[number of participants who complete minimal therapeutic dose (at least 4 sessions)\] / \[number of randomized participants in treatment arm\]
Session Attendance
Time Frame: At the post-treatment assessment (occurring at approximately 12 weeks)
For enrolled participants, attendance rates will be calculated as \[number of visits attended\] / \[number of total visits\]
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
- Change in PROMIS Sleep Related Impairment(At baseline and at the post-treatment assessment (occurring at approximately 12 weeks))
- Change in PROMIS Sleep Disturbances(At baseline and at the post-treatment assessment (occurring at approximately 12 weeks))
- Patient Adherence(At the post-treatment assessment (occurring at approximately 12 weeks))
- Acceptability of Study Procedures and SWISH(After treatment is completed (occurring at approximately 12 weeks))
- Change in Fatigue Severity Scale(At baseline and the post-treatment assessment (occurring at approximately 12 weeks))
- Change in Epworth Sleepiness Scale(At baseline and the post-treatment assessment (occurring at approximately 12 weeks))
- Change in sleep efficiency on modified Consensus Sleep Diary(At baseline and at the post-treatment assessment (occurring at approximately 12 weeks))
- Change in sleep duration on modified Consensus Sleep Diary(At baseline and at the post-treatment assessment (occurring at approximately 12 weeks))
- Change in actigraphy-derived sleep efficiency(At baseline and at the post-treatment assessment (occurring at approximately 12 weeks))
- Change in actigraphy-derived sleep duration(At baseline and at the post-treatment assessment (occurring at approximately 12 weeks))
- Change in PROMIS Emotional Distress - Depression(At baseline and at the post-treatment assessment (occurring at approximately 12 weeks))
- Change in cognition(At baseline and at the post-treatment assessment (occurring at approximately 12 weeks))