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临床试验/NCT02121652
NCT02121652已完成不适用

Translating CBT-Insomnia for Lung Cancer Into Practice: A RCT

State University of New York at Buffalo2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2014年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
44
试验地点
2
主要终点
Sleep Efficiency

研究概览

简要总结

The purpose of this study is to determine whether cognitive behavioral therapy (CBT) is effective for insomnia in lung cancer survivors.

详细描述

A randomized controlled clinical trial will be used to test the efficacy of this brief CBT-I compared to attention control on sleep, mood, functional status and quality of life in lung cancer survivors and evaluate the feasibility of translating an evidence-based CBT-I into the clinical setting.

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
None

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •6 weeks from surgery for stage 1 or 2 Non Small Cell Lung Cancer
  • •chronic insomnia

排除标准

  • •Other preexisting sleep disorders
  • •Unstable medical illnesses

研究组 & 干预措施

Healthy eating control

Active Comparator

Healthy eating control involves healthy eating content delivered in a 90 minute group session with two follow up phone calls.

干预措施: Healthy eating control (Behavioral)

Cognitive behavioral therapy

Experimental

Cognitive behavioral therapy for insomnia includes content on sleep restriction, stimulus control, relaxation, cognitive restructuring and sleep hygiene content delivered in a 90 minute group intervention with two follow up phone calls.

干预措施: Cognitive behavioral therapy for insomnia (Behavioral)

结局指标

主要结局

Sleep Efficiency

时间窗: 5 weeks

Sleep Efficiency \> 85% measured with a seven-day sleep diary. The score is calculated based on participants' recording of time asleep (minutes) divided by time in bed (minutes). Sleep Efficiency greater than or equal to 85% indicates good sleep quality, and values less than 85% indicate poor sleep quality.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Suzanne Dickerson

Principal Investigator

State University of New York at Buffalo

研究点 (2)

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