Piloting an Adaption of Cognitive Behavioral Therapy for Insomnia for Shift Workers (CBTI-Shift)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Insomnia Severity Index
研究概览
简要总结
The aim of the proposed study is to pilot test two behavioral sleep intervention strategies for improving insomnia among night shift working nurses.
详细描述
Night shift nurses with insomnia who meet all study criteria will receive one of two insomnia therapies. The specific therapy for insomnia will be determine by chance (like a flip of a coin), with an equal chance to receive either cognitive-behavioral therapy for insomnia or multicomponent relaxation therapy for insomnia, both modified for shift workers. Both therapies 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
- Parallel
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Current shift working nursing staff in Oregon
- •Expect to continue on shift work schedule during the study
- •Meets criteria for an insomnia disorder
- •Elevated insomnia symptoms
- •Have daily access to internet on a smartphone, tablet, or computer; and
- •Can read and write in English
排除标准
- •People with uncontrolled medical conditions
- •Presence of safety risk or condition in which study participation may be ineffective or result in increased risk to safety
- •Some current treatments for insomnia
- •Permanent day, evening, or rotating shift schedule
- •History of seizures or manic episode; or
- •Current/expected pregnancy during the study period
研究组 & 干预措施
CBTI
Cognitive Behavioral Therapy for Insomnia
干预措施: CBTI (Behavioral)
MRTI
Multicomponent Relaxation Therapy for Insomnia
干预措施: MRTI (Behavioral)
结局指标
主要结局
Change in Insomnia Severity Index
时间窗: At baseline and at the post-treatment assessment (occurring at approximately 10 weeks)
Validated questionnaire; total score range between 0 and 28, with higher numbers representing greater insomnia severity
Retention Rate
时间窗: At the post-treatment assessment (occurring at approximately 10 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 10 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 10 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 8 item(At baseline and at the post-treatment assessment (occurring at approximately 10 weeks))
- Change in Fatigue Severity Scale(At baseline and at the post-treatment assessment (occurring at approximately 10 weeks))
研究者
Jessee Dietch
Principal Investigator
Oregon State University