Improving PTSD Service Delivery for Veterans with Severe Mental Illness

描述（由申请人提供）： 对退伍军人医疗保健的预期影响：与一般人群一样，退伍军人事务医疗中心没有明确的治疗标准，用于治疗患有严重精神疾病的个人的创伤后应激障碍（PTSD）。这是一个相当大的问题，因为创伤，创伤后应激障碍和精神科合并症在退伍军人中特别常见，这种合并症明显加剧了精神疾病的整体病程和严重程度。这项研究的重要性在于，它提出了在VA医疗保健系统内治疗的退伍军人中建立PTSD（长期暴露）一线干预的有效性。在这方面，该项目的数据将用于为患有创伤后应激障碍的严重精神病退伍军人建立一个明确的、急需的临床行动方案。背景：创伤和创伤后应激障碍的发生率在患有严重精神疾病（SMI;即，双相情感障碍、精神分裂症）。创伤，特别是性侵害，和创伤后应激障碍也与精神疾病，生活质量下降，增加服务使用在这一人群中密切相关。尽管创伤后应激障碍的发病率很高，并且对SMI患者的功能有明显的负面影响，但关于如何有效治疗该患者人群中创伤相关症状的经验数据很少。这在很大程度上是由于历史上将患有SMI的个体排除在PTSD临床试验之外。然而，在临床环境中，临床医生也不愿意在患有SMI的患者中治疗创伤和PTSD，因为担心加重他们的主要症状。因此，大多数患有SMI的人不参加创伤/PTSD研究，在他们被照顾的公共部门环境中不治疗他们的创伤/PTSD症状，因此，继续遭受PTSD相关症状和痛苦。这个问题对于退伍军人来说尤其突出，他们通常患有创伤暴露率高，PTSD和精神病合并症相对于普通人群。目的：本研究的主要目的是比较长期暴露于PTSD（PE）加常规治疗（TAU）相对于单独TAU的相关卫生服务结局，如a）PTSD的临床症状; B）生活质量和社会适应指数; c）过程结局，如治疗可信度、服务满意度、治疗联盟和治疗依从性;以及d）成本 指数。一些额外的目的是：a）确定PE+TAU对严重精神疾病的主要症状的影响（即，精神病、单相和/或双相抑郁症状）和B）以确定临床、生活质量和过程变量（即，卫生服务变量）因农村/城市生活状况、种族、性别和/或严重精神疾病的初步诊断而异。总的来说，这些数据将为在VA医疗机构内接受治疗的患有PTSD和SMI的退伍军人建立明确的护理标准。方法：为了实现上述目标，我们将进行一项随机对照试验，比较PE+TAU与单独TAU在关键卫生服务结局中的作用。具体来说，我们将招募156名（每组n=78）种族多样的患有创伤后应激障碍和诊断为SMI的男性和女性退伍军人（即，精神障碍、双相情感障碍或严重抑郁症）。招募和同意将在查尔斯顿VA或附属社区门诊诊所（CBOC）进行。退伍军人将被随机分配至PE+TAU或单独TAU组，并在治疗后、3个月和6个月进行评价。在PE+TAU条件下的退伍军人将在查尔斯顿VA接受12次PE治疗，除了常规的SMI退伍军人护理标准（TAU;即，个案管理服务、精神科药物管理）。参与者将> 21患有PTSD和SMI。近期有精神病住院史或自杀意图和/或有活性物质滥用/依赖的退伍军人将被排除在参与之外。

DESCRIPTION (provided by applicant): Anticipated Impact on Veterans Health Care: As in the general population, there is no clear standard of care within Veterans Affairs Medical Centers for treating posttraumatic stress disorder (PTSD) among individuals with severe forms of mental illness. This is a considerable issue because trauma, PTSD, and psychiatric comorbidity are particularly common among Veterans and such comorbidity clearly exacerbates the overall course and severity of mental illness. This study is significant in that it proposes to establish the efficacy of a frontline intervention for PTSD, Prolonged Exposure, in Veterans treated within the VA healthcare system. In this regard, data from this project will be used to establish a clear, and much needed, clinical course of action for severely mentally ill Veterans suffering from PTSD. Background: Rates of trauma and PTSD are higher among individuals with severe mental illness (SMI; i.e., bipolar disorder, schizophrenia) relative to the general population. Trauma, particularly sexual victimization, and PTSD are also strongly correlated with psychiatric difficulties, decreased quality of life, and increased service use in this population. Despite the high rate of PTSD, and its clear negative impact on functioning among individuals with SMI, there are few empirical data on how to effectively treat trauma related symptoms in this patient population. This is due in large part to the historical exclusion of individuals with SMI from PTSD clinical trials. Within clinical settings as well, however, clinicians are reluctant to treat trauma and PTSD among their patients with SMI for fear of exacerbating their primary symptoms. As such, most individuals with SMI do not participate in trauma/PTSD research, are not treated for their trauma/PTSD symptoms within the public sector settings where they are cared for, and as such, continue to suffer from PTSD related symptoms and distress. This issue is particularly salient for Veterans who typically suffer from high rates of trauma exposure, PTSD, and psychiatric comorbidity relative to the general population. Objectives: The primary objectives of this study are to compare Prolonged Exposure for PTSD (PE) plus treatment as usual (TAU) relative to TAU alone across relevant health services outcomes such as a) clinical symptoms of PTSD; b) indices of quality of life and social adjustment; c) process outcomes, such as treatment credibility, satisfaction with services, therapeutic alliance, and treatment adherence; and d) cost indices. Some additional objectives are to a) determine the impact of PE+TAU on the primary symptoms of severe mental illness (i.e., psychosis, unipolar and/or bipolar depressive symptoms) relative to TAU alone and b) to determine if clinical, quality of life, and process variables (i.e., health services variables) vary by rural/urban living status, race, gender, and/ o primary diagnosis of severe mental illness. Collectively, these data will establish a clear standard of care for Veterans with PTSD and SMI who are treated within VA healthcare settings. Method: To achieve the above objectives, we will conduct a randomized controlled trial comparing PE+TAU to TAU alone across critical health services outcomes. Specifically, we will enroll 156 (n=78 per group) ethnically diverse male and female Veterans with PTSD and a diagnosis of SMI (i.e., a psychotic disorder, bipolar disorder, or severe depression) from the Charleston VA catchment area. Recruitment and consent will take place at the Charleston VA or affiliated community-based outpatient clinics (CBOCs). Veterans will be randomized to PE+TAU or TAU alone and evaluated at post, 3, and 6 months. Veterans in the PE+TAU condition will receive12 sessions of PE at the Charleston VA in addition to the regular standard of care for Veterans with SMI (TAU; i.e., case management services, psychotropic medication management). Participants will be > 21 with PTSD and SMI. Veterans with a recent history of psychiatric hospitalization or suicidal intent and/or who have active substance abuse/dependence will be excluded from participation.