Sleep, Mood, and Behavior Study:Transdisciplinary Studies of CBT for Anxiety in Youth
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Evidence of sleep therapy effects on anxiety symptoms are established by assessments of clinical status, symptoms, affective style, sleep,parent-child interactions using rating scales, self-report measures, and behavioral observations.
研究概览
简要总结
The purpose of this study is to assess whether improving sleep in children and adolescents with anxiety disorder will further enhance affective, clinical, and social functioning.
详细描述
This study is one of two interlinking protocols developed to investigate neural, affective, behavioral and social predictors of improvement as a critical next step in advancing the understanding of processes involved in the treatment response of anxiety disorders in youth. This protocol will offer a six to eight session sleep intervention (Sleeping Tigers)children ages 9-13 who currently have a DSM-IV anxiety disorder and who endorse some level of impairment in their ability to sleep. Participants will have completed a 16 session intervention for anxiety (IRB submission, Child Anxiety Treatment Study CATS). We hope to assess whether improving sleep will further enhance affective, clinical, and social functioning.
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
- 9 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of DSM-IV diagnosis of Generalized Anxiety Disorder (GAD), Separation Anxiety Disorder (SAD), and Social Phobia (SP)
- •Previous enrollment Cognitive Behavioral Therapy arm in ClinicalTrials.gov Identifier: NCT00774150 study, entitled, " Transdisciplinary Studies of CBT for Anxiety in Youth: Child Anxiety Treatment Study (CATS)"
- •The child/adolescent must have a "sleep problem" defined as: difficulties at least 3 times within a 2-week period in one or more of the following domains:
- •difficulties going to sleep
- •difficulties waking during the night
- •difficulties getting up on time for school because of tiredness/sleepiness
- •daytime tiredness and/or irritability that the child or parent attributed to insufficient sleep
- •erratic sleep-wake schedules
排除标准
- •IQ below 70 as assessed by the Wechsler Abbreviated Scale of Intelligence (WASI).
- •Requires current ongoing treatment with psychoactive medications including anxiolytics and antidepressants.
- •Acutely suicidal or at risk for harm to self or others.
- •Any motor impairments or eye-hand coordination problems
- •Sleep disorder or parasomnia.
- •Taking any medication that might interfere with sleep.
- •Has a medical problem that might interfere with sleep.
结局指标
主要结局
Evidence of sleep therapy effects on anxiety symptoms are established by assessments of clinical status, symptoms, affective style, sleep,parent-child interactions using rating scales, self-report measures, and behavioral observations.
时间窗: 6 to 8 weeks
次要结局
未报告次要终点
研究者
Neal Ryan
Joaquim Puig-Antich Professor of Psychiatry
University of Pittsburgh