PTSD Treatment for Veterans with Serious Mental Illness to Improve Functional Outcomes

对患有严重精神疾病的退伍军人进行创伤后应激障碍 (PTSD) 治疗，以改善功能结果

• 批准号: 10641181
• 负责人: Mary Katherine Howell
• 金额: --
• 依托单位: BALTIMORE VA MEDICAL CENTER
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-04-01 至 2028-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10641181
• 关键词: Address; Adherence; Aftercare; Area; Assessment tool; Bipolar Disorder; Black race; Caring; Characteristics; Chronic; Clinic; Clinical; Clinical Trials; Data; Diagnosis; Disease; Disparity; Dropout; Education; Equity; Evaluation; Evidence based practice; Exclusion; Exhibits; Formulation; Future; Goals; Healthcare; High Prevalence; Impaired cognition; Impaired health; Improve Access; Indigenous; Individual; Intervention; Interview; K-Series Research Career Programs; Knowledge; Lead; Measures; Mental Health; Mental Health Services; Mental disorders; Mentors; Methodology; Methods; Minority; Monitor; Outcome; Participant; Patient Self-Report; Physical Function; Pilot Projects; Population; Post-Traumatic Stress Disorders; Prevalence; Protocols documentation; Psychotherapy; Quality of life; Questionnaires; Randomized; Randomized, Controlled Trials; Recording of previous events; Recovery; Recovery of Function; Rehabilitation therapy; Research; Research Personnel; Severities; Specific qualifier value; Symptoms; System; Testing; Therapeutic; Therapeutic Intervention; Therapy trial; Training; Trauma; Treatment Efficacy; Treatment outcome; Veterans; Veterans Health Administration; Writing; acceptability and feasibility; brief intervention; career; career development; cognitive capacity; contextual factors; equity, diversity, and inclusion; ethnic disparity; ethnic minority; evidence base; experience; feasibility testing; follow-up; functional improvement; functional outcomes; improved; instrument; people of color; physical conditioning; pilot test; process evaluation; programs; psychoeducation; psychoeducational; psychotic; racial disparity; racial minority; recruit; rehabilitation research; research and development; response; satisfaction; severe mental illness; skills; treatment trial

Anticipated Impact on Veteran's Healthcare: PTSD is a critical obstacle to the recovery of Veterans with serious mental illness (SMI; psychotic spectrum and bipolar disorders). The Veterans Health Administration (VHA) has made treatment of PTSD a high priority and has initiated dissemination of evidence-based practices (EBPs) for PTSD across the national VHA system. However, EBPs for PTSD have not been tested among, and are largely not provided to Veterans living with both PTSD and SMI, despite high co-occurrence rates and profound associated negative functional impact. This study will: [Aim 1) administer the Cultural Formulation Interview (CFI) during a pre-pilot study of WET with 10 Veterans with SMI and PTSD to inform how best to incorporate aspects of cultural identity into the WET intervention pilot-testing in Aim 2; Aim 2) conduct a pilot randomized controlled trial (RCT) with 48 Veterans with SMI and PTSD to examine the feasibility and acceptability of WET, [monitor fidelity], and preliminarily evaluate clinical and functional outcomes; Aim 3) complete a well-specified process evaluation to determine what, if any, considerations are needed to optimize WET for Veterans with SMI and regarding culturally responsive methods. Overall impact will be to move WET towards full evaluation as a potential EBP for Veterans with PTSD and SMI. Project Background: PTSD is prevalent among Veterans and others with SMI,3-8contributing to substantial mental and physical health impairments.7,14-22 Written Exposure Therapy (WET) is a new EBP for PTSD that may have special clinical utility for Veterans with SMI and PTSD. 31,41-42,44 However, such Veterans have been largely excluded from PTSD clinical trials, and no WET trials to date have focused on an SMI population.42,45 Further, there are significant race and ethnicity disparities in PTSD and SMI prevalence and treatment, even in VHA.2,47 For instance, persistence and chronicity of SMI and PTSD are higher for Black, Indigenous, and other people of color (BIPOC),48,103 underlining the need for PTSD EBPs to be delivered in culturally responsive ways. Project Objectives: The proposed CDA-2 research will address research and clinical gaps by integrating culturally responsive assessment methods and testing the feasibility and acceptability of WET among Veterans with SMI and PTSD. [The first step of this research will focus on administering culturally responsive assessments and WET to Veterans with PTSD and SMI in a training trial (n = 10), including qualitative interviews exploring participants' experiences with and views of these instruments and WET.] The second step will involve completing a small randomized controlled trial of WET to examine feasibility, acceptability, and fidelity of WET, and to preliminary explore changes to clinical outcomes and functioning among 48 Veterans randomized to WET (n = 32) vs. a PTSD psychoeducation control intervention (n = 16). We will assess rates of recruitment, initial intervention engagement, and session attendance (feasibility); Veteran satisfaction with WET (acceptability); and preliminarily explore response to WET. The final step of this research will involve conducting a process evaluation to consider ways to optimize WET for future clinical trials to improve functional recovery for Veterans with SMI. This evaluation will synthesize information from: 1) WET interventionist notes and 2) qualitative interviews with a subset of Veterans in the WET condition (n = 15). Project Methods: This project will include: [1) delivering WET with the CFI during a training trial followed by qualitative interviews with Veterans with PTSD and SMI;] 2) completing a randomized control trial (RCT) with 48 Veteran participants, monitoring fidelity, feasibility, and acceptability; and 3) studying Veterans' experiences of WET and culturally responsive assessment methods through qualitative interviews. We will measure functional outcomes during the RCT at baseline, post-treatment and 3-month follow-up using clinician-rated and self-report questionnaires for preliminary exploratory analysis, preparatory to a future full RCT if WET proves promising.

对退伍军人医疗保健的预期影响：创伤后应激障碍 (PTSD) 是退伍军人康复的一个关键障碍 严重精神疾病（SMI；精神病谱系和双相情感障碍）。退伍军人健康管理局 (VHA) 将治疗创伤后应激障碍 (PTSD) 列为高度优先事项，并开始传播循证实践 （EBP）用于整个国家 VHA 系统的 PTSD。然而，针对 PTSD 的 EBP 尚未在以下人群中进行过测试： 尽管同时发生率很高，但基本上没有向同时患有 PTSD 和 SMI 的退伍军人提供 深远的相关负面功能影响。这项研究将：[目标 1) 管理文化配方 在 WET 预试点研究期间对 10 名患有 SMI 和 PTSD 的退伍军人进行采访 (CFI)，以了解如何最好地融入 将文化认同方面纳入目标 2 中的 WET 干预试点测试；目标 2) 进行随机对照试验 对 48 名患有 SMI 和 PTSD 的退伍军人进行试验 (RCT)，以检验 WET 的可行性和可接受性、[监测保真度]、 并初步评估临床和功能结果；目标 3) 完成明确的过程评估 确定为具有 SMI 的退伍军人优化 WET 需要考虑哪些因素（如果有），并考虑 文化响应方法。总体影响将是使 WET 作为潜在的 EBP 走向全面评估 适用于患有 PTSD 和 SMI 的退伍军人。 项目背景：PTSD 在退伍军人和其他患有 SMI 的人中普遍存在，3-8 导致大量 精神和身体健康障碍。7,14-22 书面暴露疗法 (WET) 是治疗 PTSD 的一种新 EBP，可能会 对于患有 SMI 和 PTSD 的退伍军人有特殊的临床用途。 31,41-42,44 然而，这些退伍军人大多 被排除在 PTSD 临床试验之外，并且迄今为止还没有 WET 试验关注 SMI 人群。42,45 此外， 即使在 VHA 中，PTSD 和 SMI 的患病率和治疗也存在显着的种族和民族差异。2,47 例如，对于黑人、原住民和其他种族的人来说，SMI 和 PTSD 的持续性和长期性更高。 color (BIPOC),48,103 强调需要以文化响应方式提供 PTSD EBP。 项目目标：拟议的 CDA-2 研究将通过整合来解决研究和临床差距 文化响应评估方法并测试退伍军人中 WET 的可行性和可接受性 患有 SMI 和 PTSD。 [这项研究的第一步将侧重于管理文化响应评估 和 WET 在培训试验中向患有 PTSD 和 SMI 的退伍军人 (n = 10) 提供，包括定性访谈，探讨 参与者对这些文书和 WET 的经验和看法。] 第二步将涉及完成 一项 WET 的小型随机对照试验，旨在检验 WET 的可行性、可接受性和保真度，并 初步探索 48 名随机接受 WET 的退伍军人的临床结果和功能的变化（n = 32) 与 PTSD 心理教育控制干预 (n = 16)。我们将评估招聘率、初始招聘率 干预参与度和会议出席率（可行性）；退伍军人对 WET 的满意度（可接受性）；和 初步探索对WET的反应。这项研究的最后一步将涉及进行过程评估 考虑如何在未来的临床试验中优化 WET，以改善患有 SMI 的退伍军人的功能恢复。 该评估将综合以下信息：1) WET 干预者笔记和 2) 定性访谈 处于 WET 状态的退伍军人子集 (n = 15)。 项目方法：该项目将包括：[1) 在培训试验期间与 CFI 一起提供 WET，然后 对患有 PTSD 和 SMI 的退伍军人进行定性访谈；] 2) 完成一项随机对照试验 (RCT)，其中 48 名 经验丰富的参与者，监控保真度、可行性和可接受性； 3）研究退伍军人的经历 WET 和通过定性访谈进行文化响应的评估方法。我们将测量功能 使用临床医生评分和自我报告评估随机对照试验期间基线、治疗后和 3 个月随访的结果 初步探索性分析的调查问卷，如果 WET 证明有希望的话，为未来的全面随机对照试验做准备。