A Hybrid Effectiveness-Implementation Trial of Treatments for Veterans with PTSD at Elevated Acute Risk for Suicide

背景：创伤后应激障碍（PTSD）是退伍军人自杀的一个重要危险因素。 创伤后应激障碍的循证心理疗法（EBP）降低了自杀风险，但退伍军人的急性风险升高， 自杀者，如那些从事自我导向暴力（SDV）的人，很少接受这些治疗。这 这主要是由于历史上将高风险个体排除在PTSD治疗试验之外， 缺乏关于该人群治疗的循证指南。如果没有这样的指导， 临床医生通常不愿意对有自杀倾向的个体使用EBP治疗PTSD。一种治疗方法， 辩证行为疗法（DBT），一种以自杀为重点的EBP，与DBT延长暴露（DBT PE） 针对这一高风险人群制定了一项治疗PTSD的方案，并显示出降低SDV和 和创伤后应激障碍，同时是可行的，可接受的，安全交付。然而，一项大规模的随机对照研究 试验（RCT）。本研究将比较DBT + DBT PE与当前VHA Gold的有效性 该人群的护理标准，延长暴露治疗并加强自杀风险管理 (PE+ SRM），同时还审查了在VHA中实施两种干预措施的潜力。 重要性：关于如何治疗PTSD的知识在高风险个体中存在严重差距。 自杀行为因此，VA/DoD临床实践指南未规定适应症治疗 这一人口的战略。专家们建议了两种方法来促进安全有效的 对急性自杀风险升高的个体使用EBP治疗PTSD，包括联合这些治疗 与自杀为重点的EBP或增加他们的自杀风险管理策略。这个项目将有助于 通过在患有SDV的退伍军人中严格评估这两种方法来填补这一关键空白。结果将 提供重要的信息，为指导方针提供关于这一高危人群的适应症治疗的信息。 创新性：这将是第一个大规模的随机对照试验，以评估退伍军人中创伤后应激障碍的治疗， 参与了SDV，一个HSR&D的高优先级组。DBT + DBT PE干预是第一种治疗方法 旨在解决SDV和PTSD，结果将表明这种新的治疗方法是否改善了结果 与目前的VHA黄金标准护理相比。为了促进更迅速地执行这些调查结果， 在临床实践中，还将评估两种治疗方法的实施障碍和促进因素。 具体目的：这项研究将随机抽取200名患有PTSD、近期和反复SDV、目前有自杀倾向的退伍军人。 DBT + DBT PE（干预组）或PE + SRM（对照组）的思维和情绪失调。目标1将测试 假设DBT + DBT PE在改善临床结局和参与度方面上级PE + SRM 专注于创伤治疗。探索性分析将检查可能更好预测的退伍军人特征 DBT + DBT PE与PE + SRM的参与度和成果。目标2将审查以下方面的障碍和促进因素： 两种治疗方法的实施。 方法：这是一项多中心混合1型有效性-实施试验。退伍军人将在 在三个VA站点的门诊设置，并在18个月内的5个点进行评估。混合方法将 用于评估执行的障碍和促进因素，包括与45个关键的 利益相关者（退伍军人、供应商和领导层）。 主要结局/终点：主要结局为18个月随访时SDV发作减少 以及治疗后PTSD严重程度的降低。 实施/后续步骤：该项目将提供有关如何安全和 有效地治疗创伤后应激障碍退伍军人在高急性自杀风险。如果发现一种或两种治疗方法 目标2将提供有关如何最大限度地提高未来实施成功率的重要信息。未来 将与我们的国家业务伙伴协调执行活动。

Background: Posttraumatic stress disorder (PTSD) is a significant risk factor for suicide among Veterans. Evidence-based psychotherapies (EBPs) for PTSD reduce suicide risk, but Veterans at elevated acute risk for suicide, such as those who have engaged in self-directed violence (SDV), rarely receive these treatments. This is largely due to the historical exclusion of high-risk individuals from PTSD treatment trials, which has resulted in a lack of evidence-based guidance about indicated treatments for this population. Without such guidance, clinicians are often reluctant to use EBPs for PTSD with suicidal individuals. A treatment that combines Dialectical Behavior Therapy (DBT), a suicide-focused EBP, with the DBT Prolonged Exposure (DBT PE) protocol for PTSD has been developed for this high-risk population and shows promise in reducing both SDV and PTSD while being feasible, acceptable, and safe to deliver. However, a large-scale randomized controlled trial (RCT) is needed. This study will compare the effectiveness of DBT + DBT PE to the current VHA gold standard of care for this population, Prolonged Exposure therapy augmented with suicide risk management (PE + SRM), while also examining the potential for implementation of both interventions in VHA. Significance: There is a critical gap in knowledge about how to treat PTSD among individuals at high risk for suicidal behavior. As a result, VA/DoD Clinical Practice Guidelines do not specify indicated treatment strategies for this population. Experts have recommended two approaches to facilitate the safe and effective use of EBPs for PTSD with individuals at elevated acute suicide risk, including combining these treatments with suicide-focused EBPs or augmenting them with suicide risk management strategies. This project will help to fill this critical gap by rigorously evaluating these two approaches among Veterans with SDV. The results will provide important information to inform guidelines about indicated treatments for this high-risk population. Innovativeness: This will be the first large-scale RCT to evaluate treatments for PTSD among Veterans who have engaged in SDV, an HSR&D high priority group. The DBT + DBT PE intervention is the first treatment designed to address both SDV and PTSD, and results will indicate if this novel treatment improves outcomes compared to the current VHA gold standard of care. To facilitate more rapid implementation of these findings into clinical practice, implementation barriers and facilitators for both treatments will also be evaluated. Specific Aims: This study will randomize 200 Veterans with PTSD, recent and repeated SDV, current suicidal ideation, and emotion dysregulation to DBT + DBT PE (intervention) or PE + SRM (control). Aim 1 will test the hypothesis that DBT + DBT PE will be superior to PE + SRM in improving clinical outcomes and engagement in trauma-focused treatment. Exploratory analyses will examine Veteran characteristics that may predict better engagement and outcomes in DBT + DBT PE versus PE + SRM. Aim 2 will examine barriers and facilitators to implementation of both treatments. Methods: This is a multi-site hybrid type 1 effectiveness-implementation trial. Veterans will be treated in outpatient settings at three VA sites and assessed at 5 points over 18 months. A mixed-methods approach will be used to evaluate barriers and facilitators to implementation, including conducting interviews with 45 key stakeholders (Veterans, providers, and leadership). Primary Outcomes/Endpoints: Primary outcomes will be reductions in SDV episodes at 18-month follow-up and reductions in PTSD severity at post-treatment. Implementation/Next Steps: This project will provide much-needed information about how to safely and effectively treat PTSD among Veterans at elevated acute risk for suicide. If one or both treatments are found effective, Aim 2 will provide vital information about how to maximize future implementation success. Future implementation activities would be coordinated with our national operational partners.