Implementation of an Evidence-Based PTSD Treatment in Public Sector Settings

描述(由申请人提供)：女性创伤后应激障碍是一种特别有害的慢性疾病，与严重的精神共病、高自杀率、药物滥用、自我伤害和多重创伤有关，包括反复的性侵犯和家庭暴力。公共部门的精神卫生服务是精神创伤妇女的不成比例的接受者，62%至98%的寻求治疗的妇女报告有创伤病史，在这些人中，高达40%的人被诊断为创伤后应激障碍并有各种共病。已经进行了40多项认知行为疗法治疗创伤后应激障碍的单点随机试验。然而，到目前为止，只有两个大样本随机临床试验评估了这种治疗在社区的有效性，而且都涉及军队人口。这项申请建议在四个公共精神卫生诊所为不同人群服务的合作伙伴关系的背景下，评估基于证据的创伤后应激障碍治疗的有效性。干预分为两个模块，顺序治疗(STAIR/MPE)，其中第一模块强调针对日常生活困难的情感和人际调节(STAIR)方面的当前技能培训，第二模块结合过去侧重于创伤处理的工作，使用改良的长期暴露(MPE)。这种认知行为疗法是专门为治疗患有慢性创伤后应激障碍的高危、多次创伤的女性而设计的，已被证明能够显著缓解创伤后应激障碍，并改善情绪管理和人际功能。我们将在日常临床护理的背景下评估STAIR/MPE与常规治疗(TAU)的有效性。这项研究是一项随机的、有控制的重复措施意向治疗设计，以评估STAIR/MPE在治疗后以及3个月和6个月随访时与TAU的比较。四个地点(安大略省西部、波士顿、纽约和亚特兰大)，每个地点都位于一个大型公共部门精神卫生网络中，将招募88名患有与人际暴力有关的创伤后应激障碍的寻求治疗的妇女，总共有352名研究参与者。主要结果将是创伤后应激障碍症状的严重程度。次要结果将是消极的情绪调节自我效能感、人际问题和一般精神障碍水平(GAF分数)。探索性目标包括检查治疗实施和治疗结果的变化之间的关系，以及患者特征和其他可能影响实施的背景(治疗师和组织)变量的影响。我们还将引入基于网络的技术作为一种资源，旨在加强临床网络，并在试验结束后继续使用研究材料。

DESCRIPTION (provided by applicant): PTSD among women is a particularly pernicious and chronic disorder associated with significant psychiatric comorbidity, high rates of suicidality, substance abuse, self-injury and multiple traumatization including repeated sexual assault and domestic violence. Public-sector mental health services are the disproportionate recipient of traumatized women with between 62% to 98% of treatment seeking women reporting a history of trauma and of those, up to 40% carry a diagnosis of PTSD with various comorbidities. Over 40 single-site randomized trials of cognitive-behavioral therapy for PTSD have been conducted. However, to date, there are only two large-sample randomized clinical trials which have evaluated the effectiveness of such treatments in the community and both of them concerned military populations. This application proposes to evaluate the effectiveness of an evidence-based PTSD treatment in the context of a collaborative partnership of four public mental health clinics serving diverse populations. The intervention is a two module, sequential treatment (STAIR/MPE) in which the first module emphasizes present-focused skills training in affective an interpersonal regulation (STAIR) for day-to-day life difficulties and the second module incorporates past-focused work on the processing of the trauma, using a modified version of prolonged exposure (MPE). This cognitive behavioral treatment was specifically designed to treat high risk, multiply traumatized women with chronic PTSD and has been demonstrated to provide significant and clinically substantial relief from PTSD as well as improvement in emotion management and interpersonal functioning. We will assess the effectiveness of STAIR/MPE compared to Treatment as Usual (TAU) in the context of every day clinical care. The study is a randomized, controlled repeated measures intent-to-treat design to assess STAIR/MPE as compared to TAU at post-treatment and three and six-month follow-up. Four sites (Western Ontario, Boston, New York and Atlanta), each situated within a large public sector mental health network, will enroll 88 treatment-seeking women with PTSD related to interpersonal violence yielding a total of 352 study participants. The primary outcome will be PTSD symptom severity. Secondary outcomes will be negative mood regulation self-efficacy, interpersonal problems and general level of psychiatric impairment (GAF scores). Exploratory aims include the examination of the relationship between variations in treatment implementation and treatment outcome as well as the influence of patient characteristics and other contextual (therapist and organization) variables likely to impact implementation. We will also introduce web-based technology as a resource intended to strengthen clinical networks and maintain use of study materials after the trial has ended.