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临床试验/NCT02163564
NCT02163564已完成不适用

Development of an Insomnia Treatment for Depressed Adolescents

University of Michigan2 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2012年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
2
主要终点
Insomnia Severity Index

研究概览

简要总结

Major depressive disorder (MDD) occurs at least 11% of adolescents and approximately 53-90% of those adolescents have insomnia. If left untreated, insomnia increases the risk of relapse and recurrence of depressive episodes, unintentional injuries, poor school performance, substance use, obesity, and the risk for suicide. This project seeks to develop a nonpharmacological treatment for insomnia in adolescents with depression that is feasible and effective. The specific methodologies that will help accomplish these results are: 1) use of focus groups of adolescents with depression and insomnia to determine how the current standard, nonpharmacological treatment for insomnia (cognitive-behavioral therapy for insomnia; CBTI) among adults can be modified for use by adolescents with depression and 2) determine the preliminary effectiveness, feasibility, and tolerability of group CBTI in adolescents with depression (CBTI-AD) developed using feedback from the focus groups. This project will help to improve the quality and scope of delivery of mental health services in Michigan by a) gaining a greater understanding of how sleep disturbance may perpetuate depression in adolescents and b) to provide mental health professionals with a nonpharmacological treatment option for insomnia in adolescents with depression.

研究设计

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

入排标准

年龄范围
13 Years 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Between 13-19 years of age
  • Are depressed
  • Have insomnia

排除标准

  • Are not depressed
  • Do not have insomnia
  • Currently using a sleep aid
  • Have bipolar depression
  • Have psychotic disorder
  • Have a sleep disorder other than insomnia

结局指标

主要结局

Insomnia Severity Index

时间窗: Change from baseline in insomnia at 5 weeks

A 5-item insomnia severity questionnaire

Multidimensional Fatigue Inventory

时间窗: Change from baseline in fatigue at 5 weeks

A 14-item questionnaire on fatigue

Quick Inventory of Depressive Symptomatology

时间窗: Change from baseline in depression at 5 weeks

A 16-item questionnaire on depression

次要结局

  • Alcohol and drug use screening test (CRAFFT)(Baseline)
  • Morningness Eveningness Questionnaire -modified(Baseline)

研究者

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

Deirdre A. Conroy

Clinical Associate Professor

University of Michigan

研究点 (2)

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