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临床试验/NCT00044629
NCT00044629已完成2 期

Combined Behavioral/Pharmacological Therapy for Insomnia

Duke University1 个研究点 分布在 1 个国家目标入组 162 人开始时间: 2001年9月最近更新:
适应症
干预措施
相关药物

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

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

Placebo Comparator

Cognitive Behavioral Therapy and Placebo

干预措施: Placebo (Drug)

Cognitive Behavioral Therapy alone (no drug)

Active Comparator

Cognitive Behavioral Therapy alone (no drug)

干预措施: Cognitive-Behavioral Therapy for Insomnia (Behavioral)

Cognitive Behavioral Therapy and Placebo

Placebo Comparator

Cognitive Behavioral Therapy and Placebo

干预措施: Cognitive-Behavioral Therapy for Insomnia (Behavioral)

Cognitive Behavioral Therapy and Ambien

Experimental

Cognitive Behavioral Therapy and Ambien

干预措施: Cognitive-Behavioral Therapy for Insomnia (Behavioral)

Cognitive Behavioral Therapy and Ambien

Experimental

Cognitive Behavioral Therapy and Ambien

干预措施: zolpidem tartrate (Ambien) (Drug)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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