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

描述(由申请人提供)：青少年抑郁症的心理和药物治疗产生的急性反应和缓解率充其量是适度的。为了改善这些结果，我们开发并试行了青年CBT对失眠的干预，使用来自NIMH的R34资金，作为传统的专注于抑郁症的治疗的辅助。这种改善抑郁结果的“间接途径”是基于研究表明，失眠会增加抑郁的风险，睡眠问题会干扰抑郁治疗的成功，以及最近的随机对照试验中关于成人抑郁和失眠的新研究。我们的青年飞行员随机对照试验的结果显示，抑郁症和睡眠结果令人振奋。因此，我们建议在12至19岁的抑郁青少年(12至19岁)中进行一项有足够能量的随机对照试验(N=160)，对患有失眠并刚刚开始照常使用SSRI抗抑郁药(ADS)事件疗程的抑郁青少年进行CBT干预。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)，增加TAU抗抑郁药；或(B)在对照条件下，接受可信但效果最低的睡眠卫生(SH)教育，增加TAU抗抑郁药。我们将对所有的年轻人进行12个月的跟踪。我们假设联合使用CBT-I+ADS将在初级抑郁症疗效(CGI-I和Lt；2)和重度抑郁障碍的诊断缓解方面更好，以及Actigraph的初级睡眠结局、总睡眠时间和失眠严重程度指数评分。二次分析将检验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的睡眠是否有助于抑郁症的反应-康复。适度分析将检验由于基线年龄和性别、父母参与、青年自主性、基线睡眠和抑郁严重程度而导致的干预效果的差异。我们将进行经济分析，辅以通过集成电子病历系统获得的综合医疗保健利用数据。如果我们发现CBT-I的预测效益，成本效益结果将对证明下一步的传播和实施研究是重要的。通过使用我们先前试点研究中的现有材料，包括CBT-I和SH处理材料和方案，这项研究的启动将大大加快。这项申请是对2010年全国儿童基金会理事会工作组关于干预措施的报告的优先事项的回应，特别是因为它使用了基于个体差异的个性化治疗；即存在共病失眠。青年和成年人之间的社会/发育和心理健康差异的证据表明，有必要单独试验CBT-I治疗青年失眠和抑郁症。此外，不同年龄段的失眠症的性质和影响也不同，因此开发和测试失眠症的重要性 针对青少年失眠和抑郁的干预措施。

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.