An Adjunctive Behavioral Sleep Intervention to Prevent Veteran Suicides

描述（由申请人提供）： 拟议的研究将建立概念证据，即自杀意念可以通过预防性治疗失眠来减少，失眠是一种常见的问题，既是自杀的风险因素，也是与自杀相关的常见疾病（如抑郁症和创伤后应激障碍）的高度流行。此外，在失眠得到改善的程度上，我们希望既能提高退伍军人的生活质量，又能增加他们对并发症治疗的参与。项目背景自杀是美国第十大死亡原因，是退伍军人事务部（VA）的主要关注点，并且在退伍军人中发生率较高。患有常见慢性疾病的退伍军人，如创伤后应激障碍，抑郁症，药物滥用和慢性疼痛，自杀的风险增加。虽然这些疾病存在循证治疗，但相当多的退伍军人不从事或完成这种治疗。该应用程序侧重于一个干预目标，该目标在所列的每种情况下以高比率共同发生，并且本身是自杀想法和行为的独立风险因素：失眠的睡眠障碍。因此，这项提案研究了失眠症认知行为疗法（CBT-I）的使用，这是一种针对失眠症的有效干预措施，是减少高危退伍军人自杀意念的一种新方法。重要的是，CBT-I已成功用于PTSD和抑郁症患者。在平民中进行的一项非对照试验的初步证据表明，CBT-I也可能减少自杀意念，但这尚未在退伍军人中进行过测试，在治疗并发症的背景下， 或在对照试验中。项目目标更广泛的研究计划的最终目标是减少退伍军人的自杀，而拟议的试点项目将提供数据，以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作为预防性治疗：（1）在其他正在进行的护理的背景下是可行的，并且被参与者接受;（2）可以降低有自杀风险的退伍军人中自杀意念的严重程度;（3）可以增加参与治疗的比率，该治疗解决了也使他们处于自杀风险的共病状况。后一个目标将 帮助完善研究方法、设计和干预，以期待更大规模的试验。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。被标记为自杀高风险或患有抑郁症或创伤后应激障碍的退伍军人将仅从VA站点招募。大约56名同样支持当前自杀意念和当前失眠的退伍军人将随机接受常规治疗或除常规治疗外的4次CBT-I治疗。将鼓励所有参与者继续或寻求VA治疗提供者推荐的并发症治疗。将在基线和治疗期后评估自杀意念、失眠、抑郁、PTSD和生活质量。此外，我们将在治疗后评估后立即进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逻辑回归模型来评估治疗对研究评估时间点的结局指标的影响。

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.