3/4-Optimizing Complicated Grief Therapy

描述（由申请人提供）：本重新提交申请是为了对我们先前的批准（MH060783）进行竞争性续期，我们在该批准中确定了靶向复杂悲伤治疗（CGT）的有效性。目前的申请是开展一项多中心研究，以采取下一步需要的措施，以优化患有复杂悲伤的个人的治疗方法，并响应PA-07-092邀请成人精神障碍合作研究的资助申请。复杂悲伤（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针对这种情况的随机对照试验。本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。服用抗抑郁药物的个体在两种治疗中都有更好的结果，尽管CGT在服用抗抑郁药物（60%对40%）或不服用抗抑郁药物（42%对19%）时优于IPT。抗抑郁药物单独的研究表明，与SSRIs的混合结果似乎很有希望。然而，目前尚无SSRIs类药物治疗CG的随机对照研究。确定SSRI治疗CG的疗效，无论是合并还是不合并CGT，都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良好的记录，在干预研究和多中心项目方面有丰富的经验，以开展艾司西酞普兰（ESC）疗效的研究。我们计划在4.5年内招募440名初步诊断为复杂悲伤的患者，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对应答者状态的测量以及CG症状、抑郁、焦虑、功能障碍、睡眠和自杀倾向的改善。我们将探讨中介和调节假设，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获益最多的问题。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.