Combined Behavioral/Pharmacological Therapy for Insomnia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 162
- 试验地点
- 1
研究概览
简要总结
This study will determine how sleeping pills can be combined with nondrug treatments to maximize the benefits of therapy for insomnia.
详细描述
Long-term insomnia is a common and significant health problem. Two main treatments, pharmacotherapy and behavioral therapy, have been used to help people with insomnia. Because both treatments have advantages and disadvantages, a combination of these treatments may be a good way to treat insomnia.
During the first 2 weeks of the study, participants keep a sleep log, wear an actigraph (a device that resembles a wristwatch and records activity to help determine when participants are asleep or awake), and complete questionnaires.
Participants are then randomly assigned to receive 6 weeks of behavioral therapy plus zolpidem tartrate (Ambien), behavioral therapy plus placebo, or behavioral therapy alone. During treatment, participants return to the clinic once a week to turn in their sleep logs, download their actigraph, and complete questionnaires.
After 6 weeks, participants enter the post-treatment phase of the study, which lasts 2 weeks and is identical to the 2-week assessment at the beginning of the study.
After the post-treatment phase, participants enter the follow-up period and are contacted at 3 months, 6 months, and 1 year to complete another 2-week assessment with sleep logs, actigraphy, and questionnaires.
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
入排标准
- 年龄范围
- 21 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be between 21 and 75 years of age
- •have a mean total nocturnal wake time of > 60 min./night
- •have a history of insomnia > 6 months
- •have a history of one or more poor sleep hygiene practices such as taking 3 or more naps/week, varying bed times or wake times by > 2 hrs. from day to day, or routinely lying in bed awake for periods > 30 min
排除标准
- •pregnant women
- •the terminally ill
- •individuals with other medical conditions (e.g. chronic pain disorders, etc.) that compromise sleep
- •individuals with major psychiatric diagnoses
- •persons with hypnotic-dependent insomnia
- •subjects on antidepressants or anxiolytics
- •subjects with evidence of sleep apnea
研究组 & 干预措施
Cognitive Behavioral Therapy and Placebo
Cognitive Behavioral Therapy and Placebo
干预措施: Placebo (Drug)
Cognitive Behavioral Therapy alone (no drug)
Cognitive Behavioral Therapy alone (no drug)
干预措施: Cognitive-Behavioral Therapy for Insomnia (Behavioral)
Cognitive Behavioral Therapy and Placebo
Cognitive Behavioral Therapy and Placebo
干预措施: Cognitive-Behavioral Therapy for Insomnia (Behavioral)
Cognitive Behavioral Therapy and Ambien
Cognitive Behavioral Therapy and Ambien
干预措施: Cognitive-Behavioral Therapy for Insomnia (Behavioral)
Cognitive Behavioral Therapy and Ambien
Cognitive Behavioral Therapy and Ambien
干预措施: zolpidem tartrate (Ambien) (Drug)
