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

针对急性自杀风险较高的患有创伤后应激障碍 (PTSD) 的退伍军人进行的混合有效性-实施试验

• 批准号: 10641252
• 负责人: Melanie Harned
• 金额: --
• 依托单位: VA PUGET SOUND HEALTHCARE SYSTEM
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-01 至 2027-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10641252
• 关键词: Acute; Address; Aftercare; Caring; Characteristics; Clinical; Clinical Practice Guideline; Clinical Treatment; Combined Modality Therapy; Data; Dialectical behavior therapy; Disease remission; Distress; Emotional; Evidence based treatment; Exclusion; Exposure to; Feeling suicidal; Frequencies; Guidelines; Hybrids; Individual; Intervention; Interview; Knowledge; Leadership; Life; Mental disorders; Methods; Outcome; Outpatients; Patients; Persons; Population; Post-Traumatic Stress Disorders; Prevention strategy; Promoting Action on Research Implementation in Health Services framework; Protocols documentation; Provider; Psychotherapy; Questionnaires; Randomized; Randomized, Controlled Trials; Readiness; Recommendation; Research; Risk Factors; Risk Management; Safety; Sampling; Self Direction; Severities; Site; Suicide; Suicide attempt; Suicide prevention; Testing; Time; Trauma; Veterans; Violence; clinical practice; comorbidity; compare effectiveness; effectiveness evaluation; effectiveness testing; effectiveness/implementation trial; emotion dysregulation; evidence base; follow-up; future implementation; high risk; high risk population; implementation barriers; implementation facilitators; implementation intervention; improved; improved outcome; innovation; military veteran; novel; primary outcome; psychiatric comorbidity; psychological distress; reducing suicide; response; secondary outcome; standard of care; success; suicidal; suicidal behavior; suicidal individual; suicidal risk; therapy design; treatment guidelines; treatment strategy; treatment trial

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.

背景：创伤后应激障碍（PTSD）是退伍军人自杀的重要危险因素。 PTSD的循证心理治疗（EBP）降低了自杀风险，但退伍军人的急性风险升高 自杀，例如那些从事自我指导的暴力（SDV）的自杀，很少接受这些治疗方法。这 很大程度上是由于历史排除高风险个体从PTSD治疗试验中，这导致了 在缺乏有关该人群的指定治疗方法的基于证据的指导中。没有这样的指导， 临床医生通常不愿意将EBP用于自杀个体的PTSD。一种结合的治疗 辩证行为疗法（DBT），一种以自杀为中心的EBP，DBT长期暴露（DBT PE） PTSD方案已为这种高风险人群开发，并显示出降低两种SDV的希望 和PTSD虽然可行，可接受且可以安全交付。但是，大规模随机控制 需要试验（RCT）。这项研究将将DBT + DBT PE的有效性与当前的VHA黄金进行比较 该人群的护理标准，长期暴露疗法增强了自杀风险管理 （PE + SRM），同时还研究了VHA中两种干预措施的实施的潜力。 意义：关于如何在高风险中处理PTSD的知识存在很大的差距 自杀行为。结果，VA/DOD临床实践指南未指定表示治疗 该人群的策略。专家建议采用两种方法来促进安全有效 将EBP用于PTSD，患有急性自杀风险的个体，包括结合这些治疗 以自杀为重点的EBP或通过自杀风险管理策略来增强它们。这个项目将有所帮助 通过严格评估SDV退伍军人的这两种方法，以填补这一关键空白。结果将 提供重要信息，以告知有关此高风险人群的指定治疗方法的指南。 创新性：这将是第一个评估在退伍军人中评估PTSD治疗方法的大规模RCT 已经参与了HSR＆D高优先级组SDV。 DBT + DBT PE干预是第一次治疗 旨在解决SDV和PTSD，结果将表明这种新颖的治疗方法是否改善了预后 与当前的VHA黄金护理标准相比。促进这些发现的更快实施 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子。 具体目的：这项研究将用PTSD，最近和重复的SDV随机将200名退伍军人随机 对DBT + DBT PE（干预）或PE + SRM（对照）的构想和情绪失调。 AIM 1将测试 DBT + DBT PE在改善临床结果和参与方面将优于PE + SRM的假设 以创伤为中心的治疗。探索性分析将检查可能预测更好的退伍军人特征 DBT + DBT PE与PE + SRM中的参与度和结果。 AIM 2将检查障碍和促进者 两种治疗的实施。 方法：这是一项多站点杂交1型有效性试验。退伍军人将在 在三个VA地点的门诊环境，并在18个月内以5点评估。混合方法方法将 用于评估障碍和促进者的实施，包括对45个关键进行访谈 利益相关者（退伍军人，提供者和领导人）。 主要结果/终点：主要结果将在18个月的随访中减少SDV发作 治疗后PTSD严重程度的降低。 实施/下一步：该项目将提供有关如何安全和 有效地治疗退伍军人的PTSD，急性自杀风险升高。如果发现一种或两种治疗 有效的AIM 2将提供有关如何最大化未来实施成功的重要信息。未来 实施活动将与我们的国家运营伙伴协调。