CBT-Insomnia Augmenting Usual Care SSRIs to Improve Youth Depression Outcomes

描述（由申请人提供）：青年抑郁症的心理和药物治疗产生急性反应和缓解率最好是适度的。为了改善这些结果，我们利用NIMH的R34资金，开发并试点了一种针对失眠的青少年CBT干预，作为传统抑郁症治疗的辅助手段。这种改善抑郁症治疗效果的“间接途径”是基于以下研究：失眠会增加抑郁症的风险，睡眠问题会影响抑郁症治疗的成功，以及最近的随机对照试验中关于成人抑郁症和失眠的新研究。我们的青少年先导随机对照试验结果显示，抑郁和睡眠方面的结果很有希望。因此，我们建议对青少年失眠症CBT干预（N=160）进行一项足够有力的随机对照试验（N=160），这些青少年（12至19岁）患有合并症失眠，并且刚刚开始了常规治疗（TAU） SSRI抗抑郁药（ADs）的事件疗程。符合条件的青年将被随机分为两组：(a)以失眠为重点的CBT （CBT- i）增强TAU抗抑郁药，或(b)可信但效果最低的睡眠卫生（SH）教育的对照条件增强TAU抗抑郁药。我们将跟踪所有年轻人12个月。我们假设CBT-I+ADs联合治疗在主要抑郁结果（CGI-I < 2）和主要抑郁障碍诊断缓解，以及主要睡眠结果（活动图总睡眠时间和失眠严重程度指数评分）方面更优。二次分析将检查额外的睡眠和抑郁结果，以及与NIMH研究领域标准（RDoC）倡议相关的两个结构的结果/中介。调解分析将检验改善睡眠是否有助于抑郁反应恢复。适度分析将检查由于基线年龄和性别、父母参与、青少年自主性、基线睡眠和抑郁严重程度而导致的干预效果的变化。我们将利用综合电子病历系统获得的综合医疗利用数据，进行经济分析。如果我们发现预期的CBT-I益处，那么成本效益结果将是证明下一步传播和实施研究的重要依据。通过使用我们先前试点研究中的现有材料，包括CBT-I和SH处理材料以及方案，本研究的启动将大大加快。该应用程序响应了NIMH 2010年理事会工作组干预报告的优先事项，特别是因为它使用基于个体差异的个性化治疗；即，共病性失眠的存在。青少年和成年人之间的社会/发展和心理健康差异的证据证明，需要对青少年失眠和抑郁症进行单独的CBT-I试验。此外，失眠的性质和影响在不同的年龄是不同的，这有助于开发和测试的重要性

DESCRIPTION (provided by applicant): Psychological and pharmacological treatments for youth depression yield acute response and remission rates that are modest at best. In order to improve these outcomes, we developed and piloted a youth CBT intervention for insomnia, using R34 funding from NIMH, as an adjunct to traditional depression- focused treatment. This "indirect route" to improving depression outcomes is based on research indicating that the risk of depression is increased by insomnia, that sleep problems interfere with depression treatment success, and on emerging research on adult depression and insomnia from recent RCTs. Results from our youth pilot RCT showed promising depression and sleep outcomes. Therefore, we propose to conduct an adequately powered RCT (N=160) of our youth insomnia CBT intervention with depressed adolescents (ages 12 to 19) who have comorbid insomnia and have just initiated an incident course of treatment as usual (TAU) SSRI antidepressants (ADs). Qualified youth will be randomized to either: (a) insomnia-focused CBT (CBT-I) augmenting TAU antidepressants, or (b) a control condition of credible but minimally-effective sleep hygiene (SH) education augmenting TAU antidepressants. We will follow all youth for 12 months. We hypothesize that combined CBT-I+ADs will be superior for primary depression outcomes of response (CGI-I < 2) and major depressive disorder diagnostic remission, and primary sleep outcomes of actigraphy total sleep time and score on the Insomnia Severity Index. Secondary analyses will examine additional sleep and depression outcomes, and outcomes/mediation in two constructs relevant to the NIMH Research Domain Criteria (RDoC) initiative. Mediation analyses will examine whether improved sleep contributes to depression response-recovery. Moderation analyses will examine variation in intervention effect due to baseline age and gender, parent involvement, youth autonomy, and baseline sleep and depression severity. We will conduct economic analyses, aided by comprehensive healthcare-utilization data obtained via an integrated electronic medical record system. Should we find the predicted CBT-I benefits, cost-effectiveness results will be important for justifying next-step dissemination and implementation research. The launch of this study will be substantially expedited by the use of existing materials from our prior pilot study, including the CBT-I and SH treatment materials, and protocols. This application is responsive to priorities of the NIMH 2010 Council Workgroup Report on Interventions, in particular because of its use of personalized treatments based on individual differences; i.e., the presence of comorbid insomnia. Evidence on social/developmental and mental-health differences between youth and adults warrants a separate trial of CBT-I for youth insomnia and depression. In addition, the nature and impacts of insomnia are different for different ages, contributing to the importance of developing and testing adolescent-specific interventions for insomnia and depression.