3/4-Optimizing Complicated Grief Therapy

描述（由申请人提供）：此重新提交申请是为了竞争性更新我们先前的赠款（MH 060783），其中我们建立了有针对性的复杂悲伤治疗（CGT）的疗效。目前的申请是进行一项多中心研究，以采取下一步措施，优化对患有复杂性悲伤的个人的治疗，并回应PA-07-092邀请成人精神障碍合作研究的资助申请。复杂性悲伤（CG）是一种使人衰弱的疾病，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RCT。我们研究的参与者在接受CGT或人际心理治疗（IPT）的同时继续服用稳定的抗抑郁药物。服用抗抑郁药的个体在两种治疗中的结果都更好，尽管当与（60%对40%）或不与（42%对19%）抗抑郁药联合给药时，CGT优于IPT（上级）。单独使用抗抑郁药物的研究显示，SSRIs的结果好坏参半，似乎很有希望。然而，还没有SSRIs治疗CG的随机对照研究。确定SSRI治疗CG的疗效，当与CGT和不与CGT一起施用时，具有重要的公共卫生意义。我们召集了4组在丧亲研究方面有良好记录、在干预研究和多中心项目方面有丰富经验的研究者，以进行艾司西酞普兰（ESC）疗效研究。我们计划招募440名最初诊断为复杂性悲伤超过4.5年的患者，并将他们随机分配接受16周的ESC、PBO、ESC + CGT或PBO + CGT治疗。具体目的是比较1）ESC v PBO、2）ESC + CGT v PBO + CGT和3）CGT + ESC v ESC在应答者状态指标和CG症状、抑郁、焦虑、功能障碍、睡眠和自杀倾向改善方面的差异。我们将探索中介者和调节者假设，以回答有关这些治疗方法如何工作以及谁可能从每种方法中受益最多的问题。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.