Developing a Sleep Health Intervention for Shift Workers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Retention Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)"
结局指标
主要结局
Retention Rate
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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))
研究者
Jessee Dietch
Principal Investigator
Oregon State University