2/4-Optimizing Treatment of Complicated Grief

描述(由申请人提供)：此重新提交的申请是对我们之前的资助(MH060783)的竞争性续签，在该申请中，我们确定了一种有针对性的复杂悲伤治疗(CGT)的有效性。目前的应用是进行一项多中心研究，以采取下一步所需的步骤，以优化患有复杂悲痛的个人的治疗，并响应PA-07-092邀请拨款申请，用于成人精神障碍的合作研究。复杂性悲伤(CG)是一种使人虚弱的疾病，据估计，仅在美国就有数百万人受到影响。我们之前的研究是第一个解决这种情况的随机对照试验。我们研究的参与者在接受CGT或人际心理治疗(IPT)的同时继续稳定的抗抑郁药物治疗。服用抗抑郁药物的个体在两种治疗中都有更好的结果，尽管CGT在接受抗抑郁药物治疗(60%的应答者比40%)或不服用抗抑郁药物的人(42%比19%)时优于IPT。仅抗抑郁药物的研究就显示出好坏参半的结果，SSRI似乎是有希望的。然而，目前还没有针对CG的SSRIs的随机对照研究。在使用和不使用CGT的情况下，确定SSRI治疗CG的疗效具有重要的公共卫生意义。我们召集了4组研究人员，他们在丧亲研究方面有很强的记录，在干预研究和多中心项目方面有丰富的经验，对艾司西妥兰(Esc)的疗效进行了研究。我们计划招募440名初步诊断为复杂性悲伤超过4.5年的患者，并随机分配他们接受16周的ESC、PBO、ESC+CGT或PBO+CGT治疗。具体目的是比较1)ESC与PBO，2)ESC+CGT与PBO+CGT和3)CGT+ESC与ESC在应答者状态以及在CG症状、抑郁、焦虑、功能障碍、睡眠和自杀方面的改善。我们将探索调解人和主持人假说，以回答有关这些治疗如何起作用以及谁可能从每种方法中受益最大的问题。这些问题的答案具有重要的公共卫生意义。

DESCRIPTION (provided by applicant): This resubmission application is for competitive renewals of our prior grant (MH060783) in which we established the efficacy of a targeted complicated grief treatment (CGT). The current application is to conduct a multicenter study to take the next steps needed to optimize treatment for individuals suffering from complicated grief, and responds to PA-07-092 inviting grant applications for collaborative studies of mental disorders in adults. Complicated grief (CG) is a debilitating condition that is estimated to affect millions of people in the United States alone. Our prior study was the first RCT to address this condition. Participants in our study continued stable antidepressant medication while receiving CGT or Interpersonal Psychotherapy (IPT). Individuals taking antidepressants had better outcome in both treatments, though CGT was superior to IPT when administered with (60% responders v. 40%) or without (42% v. 19%) antidepressants. Studies of antidepressant medication alone have shown mixed results with SSRIs appearing to be promising. However, there has been no randomized controlled study of SSRIs for CG. Determining the efficacy of SSRI treatment for CG, when administered with and without CGT, is of great public health importance. We have assembled 4 groups of investigators with strong track records in bereavement research and extensive experience with intervention studies and multicenter projects, to conduct a study of escitalopram (ESC) efficacy. We plan to enroll 440 people with a primary diagnosis of Complicated Grief over 4.5 years, and to randomly assign them to receive 16 weeks of treatment with ESC, PBO, ESC + CGT or PBO + CGT. Specific aims are to compare 1) ESC v PBO, 2) ESC + CGT v PBO + CGT and 3) CGT + ESC v ESC on measures of responder status and on improvement in CG symptoms, depression, anxiety, functional impairment, sleep and suicidality. We will explore mediator and moderator hypotheses to answer questions about how these treatments work and who might benefit most from each approach. Answers to these questions have important public health significance.