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

描述（由申请人提供）：青年抑郁症的心理和药物治疗产生的急性后反应和缓解率充其量是适度的。改善这些结果是我们的长期首要目标。为此，我们建议开发和测试一种青少年CBT失眠干预，作为抑郁症治疗的辅助手段。这种改善青少年抑郁症治疗效果的“间接途径”是基于一项研究，该研究表明，原发性失眠会增加患抑郁症的风险，而睡眠问题会影响抑郁症治疗的成功。我们提出的研究也基于对成年人的初步研究结果，表明在传统的抑郁症治疗中加入失眠治疗有助于显著改善抑郁症的治疗效果。然而，由于缺乏一种适合发育的、经过良好测试的治疗睡眠障碍的青少年抑郁症的方法，这一研究在青少年中的进展受到阻碍。因此，在本申请中，我们建议为患有共病抑郁症的青少年起草一份初始失眠CBT方案，并对15 - 20名患有共病失眠和单相抑郁症的青少年进行初步病例系列试验。这些试点案例将为失眠干预的最终修订提供信息。在此基础上，我们将进行一项小规模（N = 40）的青年失眠症CBT最终干预抑郁症青年共病失眠症的可行性试点RCT。这个可行性随机对照试验将把青少年随机分为以下两组：(a)以失眠为中心的CBT （CBT- i）课程，然后是以抑郁为中心的CBT (CBT- d)，或(b)失眠最小护理控制条件（观察等待，短暂的治疗师访问，睡眠卫生分发），然后是CBT- d。所有参与者将被随访6个月。该设计允许我们独立于CBT-D检查CBT-I单药治疗对睡眠和抑郁的影响。本项目主要产品为CBT-I治疗（领导者手册、青少年练习册、家庭心理教育资料）、随机对照试验方案、程序手册（MOP）、招募资料、电话脚本等。我们还将获得有关招聘成功的数据；干预交付保真度-坚持；参与者流失-留存的估计；CBT-I satisfaction-acceptability;评估电池可行性；和协议保真度时，在多个站点交付。这些材料和数据将使后续的多站点、全功率RCT能够快速启动，并通过未来的单独应用获得资金。现有的治疗青少年抑郁症的方法只有适度的效果，部分原因是失眠（经常出现）干扰了抑郁症治疗的效果。我们计划创造并测试一种失眠治疗方法，以改善青少年抑郁症的结果，同时改善睡眠。

DESCRIPTION (provided by applicant): Psychological and pharmacological treatments for youth depression yield post-acute response and remission rates that are modest at best. Improving these outcomes is our long-term, primary goal. To that end, we propose to develop and test a youth CBT insomnia intervention, to be employed as an adjunct to depression- focused treatments. This "indirect route" to improving youth depression treatment outcomes is based on research indicating that the risk of depression is increased by primary insomnia, and that sleep problems interfere with depression treatment success. Our proposed research is also based on preliminary findings with adults indicating that adding insomnia treatment to traditional depression treatments contributes to significantly better depression outcomes. However, progress in this line of research in adolescents is impeded by the lack of a developmentally-appropriate, well-tested treatment for sleep-disordered youth who are also depressed. Therefore, in this application we propose to draft an initial insomnia CBT protocol for youth with comorbid depression, and conduct initial case series piloting of the draft intervention with 15 to 20 youth with comorbid insomnia and unipolar depression. These pilot cases will inform a final revision of the insomnia intervention. Following this we will conduct a small scale (N = 40) feasibility pilot RCT of the final youth insomnia CBT intervention with depressed youth with comorbid insomnia. This feasibility RCT will randomize youth to either: (a) a course of insomnia-focused CBT (CBT-I) followed by depression-focused CBT (CBT-D), or (b) a insomnia minimal care control condition (watchful waiting, a brief therapist visit, sleep hygiene handouts), followed by CBT-D. All participants will be followed for 6 months. This design permits us to examine effects of CBT-I monotherapy on sleep and depression independent of CBT-D. The principal products of this project will be the CBT-I treatment (leader manual, youth workbook, family psycho-education materials), the RCT protocol, manual of procedures (MOP), recruitment materials, telephone scripts, etc. We will also have data regarding recruitment success; intervention delivery fidelity- adherence; estimates of participant attrition-retention; CBT-I satisfaction-acceptability; assessment battery feasibility; and protocol fidelity when delivered at multiple sites. These materials and data will enable a rapid launch of a subsequent multi-site, fully powered RCT to be funded through a future, separate application. Existing treatments for adolescent depression are only modestly effective, in part because insomnia (which is often present) interferes with how well depression treatments work. We plan to create and test an insomnia treatment to improve adolescent depression outcomes, as well as improving sleep.