Development of an Insomnia Treatment for Depressed Adolescents
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
- 否
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
Deirdre A. Conroy
Clinical Associate Professor
University of Michigan
