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Young Adult and Teen Sleep Study (YATSS)

2012年11月14日 更新者:Kaiser Permanente

Development and Piloting of CBT for Insomnia in Youth With Comorbid Depression

This study will develop and test a youth cognitive behavioral insomnia intervention to be employed as an adjunct to depression-focused cognitive behavioral treatments. The primary goal of the study is to improve the treatment and prevention of youth depression beyond that achieved with depression-focused pharmacotherapy and psychotherapies. The investigators' ultimate aim in developing this intervention is to enable a series of future outcome trials focused on improving unipolar depression outcomes in youth with comorbid insomnia, by addressing sleep dysfunction. The study will be recruiting from Kaiser Health Plan members in the Portland,Oregon metropolitan area and participants from the Bay Area region of California.

研究概览

详细说明

This controlled clinical trial (RCT) will be conducted at the Portland and UC Berkeley sites, directed respectively by Drs. Clarke and Harvey. We are conducting this small RCT at both sites is to establish the feasibility of conducting a fully-powered RCT at multiple sites to be funded by a later, separate R01 application..

Our goal is to enroll 20-30 cases at each of the two sites, for a total of up to 60 youth (30 per study condition). We propose to enroll this modest sample over a 12 month recruitment period. We expect facilitated referrals from several sources, different at each site. In Portland recruitment will be from the 16 HMO pediatric clinics in the Portland metropolitan area. In Berkeley recruitment will come in part from another region of the same HMO, with referrals facilitated by the Kaiser Permanente Department of Research in Oakland, a sister organization to Dr. Clarke's Center for Health Research (CHR) in Kaiser's Northwest region. Referrals will also come from the UBC Psychology Clinic and Dr. Harvey's Sleep and Psychological Disorders Laboratory.

Identified parents and teens will be sent study recruitment letters followed by phone calls to screened for initial eligibility. If the teen appears to be eligible the teen and parent will be scheduled to come to a baseline assessment interview. The baseline assessment is expected to take between 2-3 hours and in appreciation of their time the teen will receive a gift card for $20 and the parent will receive a gift card for $10. If the teen is eligible they will be randomized to either the control arm: sessions in time management and sleep hygiene as well as sessions of cognitive behavioral therapy for depression, or the experimental arm: a combination of CBT therapy sessions for insomnia and depression. Sessions will last from 10-12 weeks. Follow up assessments will be conducted at 12 and 26 weeks for both parent and teen with the same participant incentives as the Baseline. The teen will be asked to wear the ActiGraph watch and keep sleep diary several times throughout their enrollment.

研究类型

介入性

注册 (实际的)

41

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • California
      • Berkeley、California、美国、94720-1650
        • University of California at Berkeley
    • Oregon
      • Portland、Oregon、美国、97227
        • Kaiser Permanente Center for Health Research

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

12年 至 20年 (孩子、成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age between 12 and 20, living with a parent or guardian.
  • English language fluency.
  • Meets DSM-IV criteria for either major depression and/or dysthymia Meets Research Diagnostic Criteria (RDC) for insomnia.
  • Portland Oregon site participants must be Kaiser Health plan members.

Exclusion Criteria:

  • An active, progressive physical illness (e.g., cancer, respiratory disorder) or neurological degenerative disease (e.g., multiple sclerosis) directly related to the onset and course of the sleep disturbance.
  • Evidence from clinical diagnosis or report by youth or parent of sleep apnea, restless legs or periodic limb movements during sleep.
  • Mental retardation, autism spectrum disorder, or other significantly impairing pervasive developmental disorder.
  • Sleep treatment that might confound the interpretation of sleep outcomes.
  • Any non-insomnia, non-depressive disorder if the other comorbid condition is clearly the most severe and most impairing of all current diagnoses, and if there is a significant risk of harm and/or decompensation if treatment of that comorbid condition is delayed as a function of participating in any stage of this study. Otherwise, we will allow all other comorbid psychiatric conditions (e.g., anxiety, PTSD).

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Cognitive Behavioral Therapy for insomnia and depression
cognitive behavioral therapy for insomnia followed by cognitive behavioral therapy for depression
Experimental arm: Participants will receive sessions of cognitive behavioral treatment for insomnia followed by sessions of cognitive behavior treatment for depression for a total of about 10-12 therapy sessions Control arm: Participants will receive brief sleep hygiene and time management techniques and cognitive behavior treatment for depression for a total of about 10-12 therapy sessions.
有源比较器:contol
participants will receive sleep hygiene, time management techniques and cognitive therapy for depression
Experimental arm: Participants will receive sessions of cognitive behavioral treatment for insomnia followed by sessions of cognitive behavior treatment for depression for a total of about 10-12 therapy sessions Control arm: Participants will receive brief sleep hygiene and time management techniques and cognitive behavior treatment for depression for a total of about 10-12 therapy sessions.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Depression remission
大体时间:2 years
2 years

次要结果测量

结果测量
大体时间
Improved sleep
大体时间:2 years
2 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Gregory N Clarke, PhD、Kaiser Permanente
  • 研究主任:Allison G Harvey, PhD、University of California at Berkeley

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2009年9月1日

初级完成 (实际的)

2011年4月1日

研究完成 (实际的)

2011年8月1日

研究注册日期

首次提交

2009年7月29日

首先提交符合 QC 标准的

2009年7月29日

首次发布 (估计)

2009年7月30日

研究记录更新

最后更新发布 (估计)

2012年11月15日

上次提交的符合 QC 标准的更新

2012年11月14日

最后验证

2011年10月1日

更多信息

与本研究相关的术语

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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