Improving Sleep as a Strategy to Reduce Suicide Risk Among at-Risk Veterans: A Real World Clinical Trial

退伍军人医疗保健的预期收益 拟议的研究将确立在初级保健中治疗失眠的可行性和有效性。 环境作为一种预防自杀的策略。通过治疗失眠，这是一个常见的问题，既是一种风险 自杀因素，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(PTSD)，我们希望降低自杀意念(SI)的严重程度 经历SI、失眠和共病的退伍军人。 项目背景 自杀是美国第十大死因，是退伍军人事务部主要关注的问题 事务(VA)，并以退伍军人中较高的发生率发生。患有常见慢性病的退伍军人 创伤后应激障碍和抑郁症的自杀风险更高。尽管存在针对这些疾病的循证治疗方法 在这种情况下，相当数量的退伍军人没有参与或完成这种治疗，这让他们处于 自杀风险更高。 此应用程序建立在VA HSR&D资助的试点工作的基础上，该工作展示了交付一份简短的 失眠认知行为疗法(CBT-I)在经历SI的退伍军人的初级保健中。 试点数据表明，我们以初级保健为基础的短暂失眠治疗是高保真的， 退伍军人可以接受，并与显著减少失眠和抑郁症状有关，以及 降低了SI强度。这一研究计划的下一阶段是确定交付我们的 利用初级保健-精神卫生一体化(PC-MHI)的简要、基于初级保健的失眠干预 临床医生(相对于研究人员)，并确定干预措施的有效性，以减少 在一项确定的试验中，评估导致自杀风险的因素的严重性，并改善其他临床标志物。 项目目标 更广泛的研究计划的最终目标是通过干预来减少退伍军人的自杀 睡眠障碍是自杀的一个可改变的危险因素。在本应用程序中，我们重点关注失眠，这是 退伍军人中最常见的睡眠障碍，与自杀想法和行为密切相关。 这项拟议的临床试验的主要目标是测试是否(以及如何)使用短暂的行为失眠 治疗不仅可以改善睡眠，还可以降低其他自杀风险因素，包括自杀的严重程度 有自杀风险的退伍军人中的抑郁、创伤后应激障碍和自杀意念。次要目标是：(1) 收集有关实施障碍和促进者的初始数据，以帮助退伍军人管理局未来的实施工作 初级保健和(2)确定干预是否改善了对心理治疗的态度， 解决共同疾病的情况。 项目方法 为了实现这些目标，我们将在240名退伍军人中进行一项真实世界的随机临床试验 经历三个退伍军人病区的初级诊所招募的抑郁症或创伤后应激障碍。这些 退伍军人也将支持SI和失眠，他们将被随机接受CBT-I的一个简短疗程 或者进行类似长度的睡眠卫生干预。对自杀想法和行为的评估，失眠， 抑郁和创伤后应激障碍将在基线、治疗后和此后每6周进行一次，直到6 治疗后几个月。将应用混合效应建模和结构方程建模来确定 睡眠和其他症状(如抑郁、创伤后应激障碍)的改善如何有助于SI的减少 严肃性。此外，我们还将收集、编码和分析参与者和提供商的反馈，以评估障碍和 在现实世界的临床实践中实施的促进者。

Anticipated Benefit to VA Healthcare The proposed study will establish the feasibility and effectiveness of treating insomnia in the primary care environment as a suicide prevention strategy. By 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 posttraumatic stress disorder (PTSD), we expect to reduce the severity of suicidal ideation (SI) among Veterans experiencing SI, insomnia and a co-occurring condition. 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 and depression 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 leaving them at higher risk for suicide. This application builds upon VA HSR&D funded pilot work that demonstrated the feasibility of delivering a brief version of cognitive-behavioral therapy for insomnia (CBT-I) within primary care to Veterans experiencing SI. The pilot data suggest that our brief, primary-care based insomnia treatment was delivered with high fidelity, acceptable to Veterans and associated with significant reductions in insomnia and depression symptoms, and reduced SI intensity. The next stage of this program of research is to establish the feasibility of delivering our brief, primary care based, insomnia intervention utilizing primary care-mental health integration (PC-MHI) clinicians (as opposed to research staff) and to establish the effectiveness of the intervention on reducing the severity of factors that contribute to suicide risk and to improve other clinical markers in a definitive trial. Project Objectives The ultimate goal of the broader program of research is to reduce suicide among Veterans by intervening upon sleep disturbance as a modifiable risk factor for suicide. In this application we focus on insomnia, which is the most common sleep disorder among Veterans and is robustly associated with suicidal thoughts and behaviors. The primary objective of this proposed clinical trial is to test whether (and how) using brief behavioral insomnia treatment can not only improve sleep, but reduce other risk factors for suicide including the severity of depression, PTSD and suicidal ideation among Veterans at risk for suicide. Secondary objectives are to: (1) gather initial data on barriers and facilitators to implementation to aid future implementation efforts in VA primary care and (2) determine if the intervention improves attitudes towards psychotherapy treatments that address the co-morbid conditions. Project Methods In order to achieve these objectives we will conduct a real-world, randomized clinical trial among 240 Veterans experiencing either co-occurring depression or PTSD recruited from primary clinics at three VA sites. These Veterans, who will also endorse SI and insomnia, will be randomized to receive either a brief course of CBT-I or a sleep hygiene intervention of similar length. Assessments of suicidal thoughts and behaviors, insomnia, depression, and PTSD will be conducted at baseline, post-treatment, and every 6 weeks thereafter until 6 months post-treatment. Mixed effects modeling and structured equation modeling will be applied to determine how improvements in sleep and other symptoms (e.g. depression, PTSD) contribute to reductions in SI severity. In addition, we will collect, code and analyze participant and provider feedback to assess barriers and facilitators of implementation in real-world clinical practice.