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临床试验/NCT05965609
NCT05965609
已完成
不适用

Piloting an Adaption of Cognitive Behavioral Therapy for Insomnia for Shift Workers (CBTI-Shift)

Oregon State University1 个研究点 分布在 1 个国家目标入组 60 人2023年12月8日

概览

阶段
不适用
干预措施
CBTI
疾病 / 适应症
Circadian Rhythm Sleep-Wake Disorders, Shift Work Type
发起方
Oregon State University
入组人数
60
试验地点
1
主要终点
Change in Insomnia Severity Index
状态
已完成
最后更新
26天前

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.

注册库
clinicaltrials.gov
开始日期
2023年12月8日
结束日期
2026年3月3日
最后更新
26天前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Jessee Dietch

Principal Investigator

Oregon State University

入排标准

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

MRTI

Multicomponent Relaxation Therapy for Insomnia

干预措施: MRTI

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))

研究点 (1)

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