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：创伤后应激障碍是退伍军人康复的关键障碍 严重精神疾病(SMI；精神病谱和双相情感障碍)。退伍军人健康管理局 (VHA)已将治疗创伤后应激障碍列为高度优先事项，并已开始传播循证做法 (EBPS)在全国VHA系统中用于创伤后应激障碍。然而，针对创伤后应激障碍的EBPS尚未在 基本上不提供给同时患有创伤后应激障碍和精神分裂症的退伍军人，尽管同现率很高， 与之相关的深远的负面功能影响。本研究将：[目标1]管理文化提法 与10名患有SMI和创伤后应激障碍的退伍军人进行WEW试点研究期间的访谈(CFI)，以了解如何最好地将 将文化认同方面纳入湿干预试点--在目标2中进行测试；目标2)进行试点随机对照 对48名患有SMI和创伤后应激障碍的退伍军人进行试验(RCT)，以检查WEAM、[监控保真度]、 并初步评估临床和功能结果；目标3)完成详细说明的过程评估，以 确定为具有SMI的退伍军人优化湿润环境需要考虑的事项(如果有)，并考虑到 响应文化的方法。总体影响将是将湿性转向全面评估为潜在的EBP 适用于患有创伤后应激障碍和精神障碍的退伍军人。 项目背景：创伤后应激障碍在退伍军人和其他人中很普遍，3-8岁的SMI对 7、14-22书面暴露疗法(WEW)是一种治疗创伤后应激障碍的新EBP，它可能 对患有重度精神障碍和创伤后应激障碍的退伍军人有特殊的临床效用。31，41-42，44然而，这样的退伍军人基本上 被排除在创伤后应激障碍临床试验之外，到目前为止还没有湿性试验专注于SMI人群。42，45进一步， 在创伤后应激障碍和SMI的患病率和治疗方面存在显著的种族和民族差异，即使在VHA2，47 例如，SMI和PTSD的持久性和长期性对于黑人、土著和其他 颜色(BIPOC)，48,103强调需要以响应文化的方式提供创伤后应激障碍预防方案。 项目目标：拟议的CDA-2研究将通过整合 退伍军人文化响应性评估方法及其可行性和可接受性检验 患有SMI和创伤后应激障碍。[这项研究的第一步将侧重于管理文化响应性评估 对患有创伤后应激障碍和精神障碍的退伍军人进行培训试验(n=10)，包括定性访谈，探索 与会者对这些工具和湿润环境的经验和看法。]第二步将包括完成 一项小型随机对照湿润试验，以检验湿润的可行性、可接受性和保真度，并 48名退伍军人随机分为湿组(n=48)，初步探讨临床结局和功能的变化 32)与创伤后应激障碍心理教育控制干预(n=16)。我们将评估招聘率，最初 干预参与度和出席率(可行性)；退伍军人对湿润环境的满意度(可接受性)；以及 初步探索对潮湿的反应。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WEW，以改善患有SMI的退伍军人的功能恢复。 这项评估将综合以下信息：1)湿干预者笔记和2)定性访谈 湿条件下的退伍军人子组(n=15)。 项目方法：该项目将包括：[1]在培训试验期间使用CFI交付湿气，然后 对患有创伤后应激障碍和精神障碍的退伍军人进行定性访谈；]2)完成了一项随机对照试验(RCT)，共有48人 退伍军人参与者，监测忠诚度、可行性和可接受性；以及3)研究退伍军人的经验 通过定性访谈的湿性和文化响应性评估方法。我们将测量泛函 使用临床医生评分和自我报告进行随机对照试验期间基线、治疗后和3个月随访的结果 初步探索性分析的问卷调查，如果湿的话为未来的全面RCT做准备被证明是有希望的。