RCT of CBT for Insomnia With PLWHA
2016年5月5日 更新者：Amit Shahane、Emory University
A Randomized Controlled Trial of Cognitive Behavior Therapy for Insomnia With Persons Living With HIV/AIDS
The proposed study will consist of a randomized controlled trial (RCT) comparing a known efficacious treatment for insomnia (CBT-I) to a sleep hygiene (SH) comparison condition.
研究概览
详细说明
The purpose of this study is to test whether a group cognitive-behavioral treatment program for insomnia (CBT-I) will help adults diagnosed with HIV to improve the quantity (number of hours) and the quality of their sleep.
The PI will compare adults who participated in the CBT-I program to adults who participated in a Sleep Hygiene group, a common treatment for insomnia.
The PI will look at the overall quality of life, and number of hours and quality of sleep of adults who participated in the CBT-I program versus adults in the Sleep Hygiene group.
Also, the PI will draw blood to compare how the body responds to medical illnesses between adults in the CBT-I program to adults in the Sleep Hygiene group.
研究类型
介入性
注册 (实际的)
34
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Georgia
-
Atlanta、Georgia、美国、30303
- Grady Memorial Hospital/Infectious Disease Program
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- English-speaking individuals
- over the age of 18 years old with a diagnosis of HIV or AIDS who is receiving medical care at the Grady Health System's Infectious Disease Program (IDP)
- study subjects must meet the criteria for primary or secondary insomnia as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision
- must experience difficulty initiating or maintaining non-restorative sleep for at least l month (DSM- IV-TR)
- the sleep disturbance causes clinically significant impairment or distress in important areas of functioning
- sleep efficiency of less than 85%, sleep disturbances that occur three or more days per week, and sleep latency (i.e., time awake after sleep onset greater than 30 minutes)
Exclusion Criteria:
- current substance dependence (within the past six months)
- active psychosis
- Bipolar I and II disorders
- neurocognitive impairment and/or a current diagnosis of dementia
- lack of independent housing
- previous participation in a CBT-I program
- employment in a job requiring shift work that impairs the ability to establish a regular sleep schedule
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：CBT-I Treatment Condition
The CBT-I treatment condition will be delivered in a one-hour per week group format (10 participants) occurring over the course of six-weeks.
Four total CBT-I groups occurring over the course of two years will be implemented, with at total of 40 participants enrolled for the CBT-I condition.
|
Each group will last approximately 1 hour and will involve completing surveys in order to track both the quantity and quality of sleep.
Blood will be drawn twice in order to compare how the body responds to medical illnesses.
|
|
有源比较器：SH Comparison Condition
The SH comparison condition will also be delivered in a one-hour per week group format (10 participants) occurring over the course of six-weeks.
Four total SH groups over the course of two years will be conducted, with a total of 40 participants enrolled for the SH condition.
|
Each group will last approximately 1 hour and will involve completing surveys in order to track both the quantity and quality of sleep.
Blood will be drawn twice in order to compare how the body responds to medical illnesses.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Insomnia Symptoms
大体时间：baseline, up to 5 weeks post-intervention
|
Compare insomnia scores on the Insomnia Severity Index (questionnaire) between the CBT-I treatment condition vs. SH comparison condition.
|
baseline, up to 5 weeks post-intervention
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Quality of Life
大体时间：baseline, up to 5 weeks post-intervention
|
Compare quality of life scores on the HIV/AIDS Targeted-Quality of Life (scale) between CBT-I treatment condition vs. SH comparison condition.
|
baseline, up to 5 weeks post-intervention
|
|
Blood Sample
大体时间：baseline, up to 5 weeks post-intervention
|
Evaluate and compare markers of inflammation between participants in the CBT-I treatment condition vs. SH comparison condition.
|
baseline, up to 5 weeks post-intervention
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Amit Shahane, Ph.D.、Emory University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年11月1日
初级完成 (实际的)
2016年2月1日
研究完成 (实际的)
2016年2月1日
研究注册日期
首次提交
2014年10月2日
首先提交符合 QC 标准的
2014年10月3日
首次发布 (估计)
2014年10月8日
研究记录更新
最后更新发布 (估计)
2016年5月6日
上次提交的符合 QC 标准的更新
2016年5月5日
最后验证
2016年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.