An Adjunctive Behavioral Sleep Intervention to Prevent Veteran Suicides

描述(由申请人提供)： 对退伍军人管理局医疗保健的预期好处拟议中的研究将建立一个概念证据，即通过辅助治疗失眠可以减少自杀意念。失眠是一种常见的问题，既是自杀的危险因素，也在与自杀有关的常见疾病中非常普遍，如抑郁症和创伤后应激障碍。此外，在失眠得到改善的情况下，我们预计既能提高退伍军人的生活质量，又能增加他们对共生疾病的治疗参与度。项目背景自杀是美国第十大死因，是退伍军人事务部(VA)关注的主要问题，而且在退伍军人中的发生率很高。患有创伤后应激障碍、抑郁症、药物滥用和慢性疼痛等常见慢性疾病的退伍军人自杀风险更高。尽管存在针对这些疾病的循证治疗，但相当数量的退伍军人并未参与或完成此类治疗。这项应用专注于一种干预目标，该目标在所列的每一种情况下都会以高比率同时出现，本身就是自杀想法和行为的独立风险因素：失眠的睡眠障碍。因此，这项建议研究了失眠认知行为疗法(CBT-I)的使用，这是一种针对失眠的有效干预措施，作为减少高危退伍军人自杀意念的一种新方法。重要的是，CBT-I已经成功地用于创伤后应激障碍和抑郁症患者。在平民中进行的一项不受控制的试验的初步证据表明，CBT-I也可能减少自杀意念，但这还没有在退伍军人身上进行测试，在治疗共生疾病的背景下， 或在对照试验中。项目目标更广泛的研究项目的最终目标是减少退伍军人中的自杀，而拟议的试点项目将提供数据，指导更大规模试验的发展。该试点项目的主要目标是测试 使用CBT-I作为一种辅助治疗：(1)在其他持续护理的背景下提供是可行的，并为参与者所接受；(2)可以减轻有自杀风险的退伍军人的自杀念头的严重性；以及(3)可以提高参与治疗的比率，以解决也使他们面临自杀风险的共病情况。后一个目标将 帮助改进研究方法、设计和干预，以期进行更大规模的试验。项目方法为了实现这些概念验证目标，我们将进行一项小型随机临床试验。被标记为自杀风险高的退伍军人，或者患有抑郁症或创伤后应激障碍的退伍军人将仅从退伍军人管理局招募。大约56名这样的退伍军人也支持目前的自杀意念和目前的失眠，他们将被随机分成在照常治疗的基础上接受照常治疗或4个疗程的CBT-I治疗。将鼓励所有参与者继续接受治疗，或按照退伍军人管理局治疗提供者的建议寻求治疗。自杀意念、失眠、抑郁、创伤后应激障碍和生活质量的评估将在基线和治疗期之后进行。此外，我们将在治疗后评估后立即举行的离职面谈中收集提供者和参与者的反馈。我们将使用多元线性和Logistic回归模型来评估治疗对研究评估时间点结果的影响。

DESCRIPTION (provided by applicant): Anticipated Benefit to VA Heathcare The proposed study will establish proof of concept that suicidal ideation can be reduced by adjunctively treating insomnia, a common problem that is both a risk factor for suicide and highly prevalent in common conditions associated with suicide such as depression and PTSD. In addition, to the extent that insomnia is improved, we expect to both enhance Veteran's quality of life and increase their engagement with treatments for co-occurring conditions. Project Background Suicide is the tenth leading cause of death in the U.S., is a major concern of the Department of Veterans Affairs (VA), and occurs at elevated rates among Veterans. Veterans with common chronic conditions such as PTSD, depression, substance abuse and chronic pain are at increased risk for suicide. Although evidence- based treatments exist for these conditions, a significant number of Veterans do not engage in or complete such treatments. This application focuses on an intervention target that co-occurs in each of the listed conditions at high rates and is itself an independent risk factor for suicidal thoughts and behaviors: the sleep disturbance of insomnia. Therefore, this proposal examines the use of cognitive-behavioral therapy for insomnia (CBT-I), an efficacious intervention that targets insomnia, as a novel way to reduce suicidal ideation in at-risk Veterans. Importantly, CBT-I has been successfully used in patients with PTSD and depression. Preliminary evidence from an uncontrolled trial in civilians suggests that CBT-I may also decrease suicidal ideation, but this has not been tested in Veterans, in the context of treatments for co-occurring conditions, or in a controlled trial. Project Objectives The ultimate goal of the broader program of research is to reduce suicide among Veterans, while the proposed pilot project will provide data to guide the development of a larger trial. The primary objectives of this pilot project are to test whether using CBT-I as an adjunctive treatment: (1) is feasible to deliver in the context of other ongoing care and acceptable to participants; (2) can reduce the severity of suicidal ideation among Veterans at risk for suicide; and (3) can increase rates of engagement in treatments that address the co- morbid conditions that also put them at risk for suicide. The latter objective will help refine the study methods, design, and intervention in anticipation of a larger trial. Project Methods In order to achieve these proof-of-concept objectives we will conduct a small randomized clinical trial. Veterans who are either flagged as high risk for suicide or who have depression or PTSD will be recruited from VA sites only. Approximately 56 such Veterans who also endorse current suicidal ideation and current insomnia will be randomized to receive either treatment-as-usual or a 4-session CBT-I treatment in addition to treatment-as- usual. All participants will be encouraged to continue or to seek treatment for co-occurring conditions as recommended by their VA treatment providers. Assessments of suicidal ideation, insomnia, depression, PTSD, and quality of life will be conducted at baseline and following the treatment period. In addition, we will collect provider and participant feedback at an exit interview immediately following the post-treatment assessment. We will use multiple linear and logistic regression models to assess the effect of treatment on outcome measures across the study assessment time points.