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多是适度的。为了改善这些结果，我们开发并试点了一项针对失眠的青少年CBT干预，使用NIMH的R34资金，作为传统抑郁症集中治疗的辅助手段。这种改善抑郁症结局的“间接途径”是基于以下研究：失眠会增加抑郁症的风险，睡眠问题会干扰抑郁症治疗的成功，以及最近RCT中关于成人抑郁症和失眠的新兴研究。我们的青年试点RCT结果显示，抑郁症和睡眠结果很有希望。因此，我们建议进行一项有充分把握的RCT（N=160），对患有失眠症的抑郁青少年（12至19岁）进行青少年失眠CBT干预，这些青少年患有失眠症，并且刚刚开始了一个事件疗程（TAU）SSRI抗抑郁药（AD）。合格的青少年将被随机分配到：（a）失眠集中的CBT（CBT-I）增强TAU抗抑郁药，或（B）可信但最小有效的睡眠卫生（SH）教育增强TAU抗抑郁药的对照条件。我们将跟踪所有青年12个月。我们假设CBT-I+ AD联合治疗在原发性抑郁症疗效（CGI-I < 2）和重度抑郁症诊断缓解以及体动记录总睡眠时间和失眠严重程度指数评分的原发性睡眠结局方面具有上级优势。次要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中的结果/中介。中介分析将检查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，青少年自主性以及基线睡眠和抑郁严重程度而导致的干预效果的变化。我们将进行经济分析，通过综合电子病历系统获得的综合医疗保健利用数据的帮助。如果我们发现预测的CBT-I的好处，成本效益的结果将是重要的，证明下一步的传播和实施研究。本研究的启动将通过使用我们先前试点研究的现有材料（包括CBT-I和SH治疗材料和方案）而大大加快。该应用程序响应了NIMH 2010年理事会干预工作组报告的优先事项，特别是因为它使用了基于个体差异的个性化治疗;即，失眠症的存在关于青少年和成年人之间社会/发展和心理健康差异的证据表明，需要对CBT-I进行单独的青少年失眠和抑郁症试验。此外，失眠的性质和影响对不同年龄的人来说是不同的，这也说明了开发和测试失眠的重要性。 失眠症和抑郁症的治疗。

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.