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

改善睡眠作为降低高危退伍军人自杀风险的策略：真实世界的临床试验

• 批准号: 10532670
• 负责人: Jennifer S Funderburk
• 金额: --
• 依托单位: SYRACUSE VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-01-01 至 2023-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10532670
• 关键词: Address; Aftercare; Attitude; Behavioral; Caring; Cause of Death; Chronic; Clinic; Clinical Markers; Clinical Trials; Code; Cognitive Therapy; Data; Effectiveness; Effectiveness of Interventions; Environment; Equation; Evidence based treatment; Feedback; Feeling suicidal; Funding; Goals; Growth and Development function; Happiness; Health Personnel; Healthcare; Intervention; Interview; Length; Mediating; Mental Depression; Mental Health Services; Methods; Military Personnel; Modeling; Participant; Patient Self-Report; Post-Traumatic Stress Disorders; Prevention strategy; Primary Care; Provider; Psychotherapy; Randomized; Recommendation; Research; Risk; Risk Factors; Severities; Site; Sleep; Sleep Disorders; Sleep disturbances; Sleeplessness; Structure; Suicide; Suicide prevention; Symptoms; Testing; Time; Treatment Effectiveness; United States Department of Veterans Affairs; Veterans; Veterans Health Administration; Work; acceptability and feasibility; clinical practice; comorbidity; depressive symptoms; efficacious treatment; experience; follow-up; future implementation; high risk; implementation efforts; implementation facilitators; improved; improvement on sleep; information gathering; intervention delivery; intervention effect; modifiable risk; novel; optimism; post intervention; primary care clinic; primary care clinician; programs; randomized trial; randomized, clinical trials; recruit; reduce symptoms; reducing suicide; sleep health; social stigma; suicidal behavior; suicidal risk; suicide rate; treatment as usual

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.

VA Healthcare的预期受益 这项拟议的研究将确立在基层保健中治疗失眠的可行性和有效性 环境作为预防自杀的策略。通过治疗失眠这一既有风险又常见的问题 自杀因素，在与自杀相关的常见疾病中非常普遍，如抑郁症和 创伤后应激障碍（PTSD），我们希望减少自杀意念（SI）的严重程度， 退伍军人经历SI，失眠和共同发生的条件。 项目背景 自杀是美国第十大死亡原因，是退伍军人部的主要关注点 事务（VA），并发生在退伍军人的高利率。患有常见慢性病的退伍军人，如 PTSD和抑郁症会增加自杀的风险。虽然有证据为基础的治疗存在这些 在这种情况下，相当多的退伍军人不从事或完成这种治疗，使他们在 自杀的风险更高。 此应用程序建立在VA HSR&D资助的试点工作的基础上，该工作证明了提供简短的可行性 在初级保健中对经历SI的退伍军人进行失眠的认知行为疗法（CBT-I）。 试点数据表明，我们的简短，初级保健为基础的失眠治疗提供了高保真， 退伍军人可以接受，并与失眠和抑郁症状的显着减少有关， 降低SI强度。这项研究计划的下一阶段是确定提供我们的 利用初级保健-心理健康整合（PC-MHI）进行基于初级保健的简短失眠干预 临床医生（而不是研究人员），并确定干预措施对减少 导致自杀风险的因素的严重程度，并在确定性试验中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减少退伍军人的自杀。 睡眠障碍是自杀的可改变的危险因素。在这个应用程序中，我们专注于失眠，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的是测试是否（以及如何）使用短暂的行为失眠 治疗不仅可以改善睡眠，还可以减少自杀的其他危险因素，包括 抑郁症，创伤后应激障碍和自杀意念在退伍军人自杀风险。次要目标是：（1） 收集关于实施障碍和促进因素的初始数据，以帮助VA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， 解决并发症 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 从三个退伍军人管理局的初级诊所招募的同时患有抑郁症或创伤后应激障碍的患者。这些 退伍军人，谁也将赞同SI和失眠，将被随机接受一个简短的过程CBT-I 或类似长度的睡眠卫生干预。对自杀念头和行为，失眠， 抑郁症和PTSD将在基线、治疗后和此后每6周一次进行，直至6 治疗后数月。将采用混合效应模型和结构方程模型来确定 如何改善睡眠和其他症状（如抑郁症，创伤后应激障碍）有助于减少SI 严重性。此外，我们将收集、编码和分析参与者和提供者的反馈，以评估障碍， 在现实世界的临床实践中实施的促进者。