NCT01846585已完成不适用
The Effectiveness of Non-Pharmacological Treatment for Insomnia During Pregnancy
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
- 194
- 试验地点
- 2
- 主要终点
- Rate of insomnia remission
研究概览
简要总结
The aim of the study is to improve sleep during pregnancy and the postpartum period in women who are experiencing insomnia, using a brief non-pharmacological treatment.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Meets Diagnostic and Statistical Manual (IV-TR edition) criteria for insomnia (duration criterion - 1 month)
- •Pregnant with gestational age between 18-32 weeks.
- •Adequately fluent in English or Spanish.
排除标准
- •Some co-morbid sleep disorders (e.g., moderate to severe obstructive sleep apnea)
- •Co-morbid psychiatric disorder
- •Use of medications, herbs or other drugs with known effects on sleep
- •Unstable medical conditions
- •Currently engaged in psychotherapy or other treatments for insomnia
研究组 & 干预措施
ABTI
Other
Arousal Based Therapy for Insomnia
干预措施: Arousal Based Therapy for Insomnia (Behavioral)
CBTI
Other
Cognitive Behavioral Therapy for Insomnia
干预措施: Cognitive Behavioral Therapy for Insomnia (Behavioral)
结局指标
主要结局
Rate of insomnia remission
时间窗: Baseline to 30 weeks postpartum
次要结局
- Insomnia severity(Baseline to 30 weeks postpartum)
- Depression severity(Baseline to 30 weeks postpartum)
- Sleep Characteristics(Baseline to 30 weeks postpartum)
研究者
Rachel Manber
Professor
Stanford University
研究点 (2)
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