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

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青年CBT失眠干预，作为专注于抑郁症的治疗的辅助手段。这种改善青少年抑郁症治疗结果的“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，而睡眠问题会干扰抑郁症治疗的成功。我们提出的研究也是基于对成年人的初步发现，即在传统的抑郁症治疗基础上增加失眠治疗有助于显著改善抑郁症结果。然而，由于缺乏对同样患有抑郁症的睡眠障碍青少年进行适合发育的、经过充分测试的治疗方法，在青少年这一领域的研究进展受到了阻碍。因此，在本申请中，我们建议为患有共病抑郁症的青年起草一份初步的失眠CBT方案，并对15至20名患有共病失眠和单相抑郁的青年进行初步的病例系列干预草案试点。这些试点案例将为失眠干预的最终修订提供信息。在此之后，我们将进行一项小规模(N=40)的可行性随机对照试验，以最终的青年失眠CBT干预抑郁青年合并失眠。这项可行性随机对照试验将青少年随机分为两组：(A)以失眠为重点的CBT-I疗程，然后是以抑郁为重点的CBT(CBT-D)，或(B)失眠最低限度护理控制条件(观察等待、短暂的治疗师访问、睡眠卫生讲义)，然后是CBT-D。所有参与者将被跟踪6个月。这项设计允许我们检验CBT-I单一疗法对睡眠和抑郁的影响，独立于CBT-D。该项目的主要产品将是CBT-I治疗(领导者手册、青年工作手册、家庭心理教育材料)、随机对照试验方案、程序手册(MOP)、招聘材料、电话脚本等。我们还将获得关于招募成功的数据；干预措施提供的忠诚度遵守情况；对参与者自然减员的估计-保留；CBT-I满意度-可接受性；评估小组的可行性；以及在多个地点提供的礼仪忠诚度。这些材料和数据将使随后的多站点、全功率随机对照试验能够迅速启动，并将通过未来的单独应用程序提供资金。现有的治疗青春期抑郁症的方法只有一定的效果，部分原因是失眠(通常存在)干扰了抑郁症治疗的效果。我们计划创造并测试一种治疗失眠的方法，以改善青少年抑郁症的结果，以及改善睡眠。

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.