Intervention for Sleep and Pain in Youth: A Feasibility Study of Cognitive-Behavioral Intervention
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
- 否
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
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
Emily Law
Assistant Professor, Anesthesiology & Pain Medicine
Seattle Children's Hospital
