A Randomized Controlled Trial of Cognitive Behavior Therapy for Insomnia With Persons Living With HIV/AIDS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Insomnia Symptoms
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: CBT-I Treatment Condition (Behavioral)
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.
干预措施: SH Comparison Condition (Behavioral)
结局指标
主要结局
Insomnia Symptoms
时间窗: 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.
次要结局
- Blood Sample(baseline, up to 5 weeks post-intervention)
- Quality of Life(baseline, up to 5 weeks post-intervention)
研究者
Amit Shahane
Assistant Professor
Emory University