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临床试验/NCT03137147
NCT03137147已完成不适用

Intervention for Sleep and Pain in Youth: A Feasibility Study of Cognitive-Behavioral Intervention

Seattle Children's Hospital2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2016年10月1日最近更新:
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
21
试验地点
2
主要终点
Feasibility of Intervention Delivery: Number of Completed Intervention Visits

研究概览

简要总结

This study tests the feasibility, acceptability, and preliminary efficacy of a seven-session cognitive-behavioral therapy intervention to treat sleep and pain problems in youth ages 11-17 with co-morbid headache and insomnia.

详细描述

Cognitive-behavioral interventions have been developed to treat childhood insomnia and childhood headache. In this study, we have combined strategies from these interventions into a single, seven-session protocol to treat sleep and pain problems in youth with co-morbid headache and insomnia. In this single-arm pilot study, we will test the feasibility, acceptability, and preliminary efficacy of this intervention.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
11 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • youth age 11-17 years
  • chronic headache and insomnia symptoms for the past 3 months as determined on screening interview with youth and parent.

排除标准

  • youth and parent do not read or speak English
  • youth with active suicidal ideation or psychosis
  • youth with diagnosis of a comorbid serious health condition (e.g., cancer, diabetes)
  • youth with severe cognitive impairment
  • youth with another primary sleep disorder (e.g., sleep apnea, narcolepsy) or an unusual sleep/wake schedule or circadian rhythm disorder.

研究组 & 干预措施

Cognitive-Behavioral Therapy

Other

Intervention for Sleep and Pain in Youth, a 7-session cognitive-behavioral therapy intervention for co-morbid insomnia and headache

干预措施: Intervention for Sleep and Pain in Youth (Behavioral)

结局指标

主要结局

Feasibility of Intervention Delivery: Number of Completed Intervention Visits

时间窗: 6-12 weeks

Number of completed intervention visits

Feasibility of Intervention Delivery: Recruitment/Enrollment Rate

时间窗: 6-12 weeks

Recruitment/Enrollment Rate

次要结局

  • Treatment Acceptability and Satisfaction: Treatment Evaluation Inventory Short Form(3 months)
  • Insomnia Severity Index(3 months)
  • Adolescent Sleep Wake Scale(Past 4 weeks)
  • Pain Questionnaire(Past 2 weeks)
  • Child Activity Limitations Interview(Past month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emily Law

Assistant Professor, Anesthesiology & Pain Medicine

Seattle Children's Hospital

研究点 (2)

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Intervention for Sleep and Pain in Youth | 临床试验