NCT03012425已完成不适用
Pilot Study of Cognitive Behavioral Therapy for Insomnia (CBT-I) and Acupuncture for Insomnia and Related Distress Among Cancer Caregivers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 4
- 主要终点
- number of participants who complete the assessments
研究概览
简要总结
The other aim of this study is to determine which of those two treatments (acupuncture or cognitive behavioral therapy) works better for treating insomnia in Informal Caregivers of cancer patients.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •As per self report, age 18 and older
- •As per self report, identifying as an informal caregiver to MSKCC patients of any site or stage of cancer
- •Score greater than 7 on the Insomnia Severity Index and meet the criteria for Insomnia Disorder as defined by the Diagnostic and Statistical Manual of Mental disorders, 5th Edition (DSM-5) (56) as assessed by the Insomnia Interview Schedule
- •In the judgment of the investigators and/or consenting professional, able to read and comprehend English
- •In the judgment of the consenting professional cognitively able to provide informed consent
排除标准
- •As per self report, participant has another sleep disorder provided that it is not adequately treated (e.g., sleep apnea without CPAP treatment)
- •As per self report, participant has major depressive disorder, alcohol or drug dependence and
- •As per self report, heavy drinker (regularly having more than 14 alcoholic beverages per week)
- •As per self report, engaging in night shift work
- •To not obscure cortisol assessment, regular smokers per self report (daily use) will be excluded.
- •As per self report significant needle phobia as to prevent participation in acupuncture
结局指标
主要结局
number of participants who complete the assessments
时间窗: 1 year
treatment tolerability (rate of CBT-I and acupuncture completion, defined as completing at least 4 out of 7 sessions of CBT-I and 8 out of 10 sessions of acupuncture)
次要结局
未报告次要终点
研究者
研究点 (4)
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