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2/4-Optimizing Treatment of Complicated Grief

2/4-复杂悲伤的优化治疗

基本信息

批准号：
7730276
负责人：
NAOMI M SIMON
金额：
$ 41.11万
依托单位：
MASSACHUSETTS GENERAL HOSPITAL
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-08-15 至 2014-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7730276
关键词：
Accounting Acquired Immunodeficiency Syndrome Address Adherence Administrative Coordination Adult Affect Aftercare Antidepressive Agents Anxiety Applications Grants Arbitration Audiotape Bereavement Biometry California Cardiovascular Diseases Certification Cessation of life Clinical Clinical Services Clinical Trials Data Monitoring Committees Combination Drug Therapy Combined Modality Therapy Communication Communities Confidentiality Consent Data Data Analyses Data Base Management Data Collection Diagnosis Disputes Distress Dose Electronic Mail Enrollment Ensure Equipment and supply inventories Escitalopram Ethnic group Exclusion Criteria Frequencies Funding Goals Grant Grief reaction Health Human Resources Impairment Individual Intervention Studies Interview Leadership Life Malignant Neoplasms Manuals Measures Mediating Mediator of activation protein Mental disorders Methods Modeling Monitor Multicenter Studies Online Systems Operative Surgical Procedures Outcome Participant Patients Persons Pharmaceutical Preparations Pharmacotherapy Phase Placebos Procedures Protocols documentation Psychopharmacology Psychotherapy Public Health Public Health Schools Publications Randomized Randomized Controlled Trials Records Recruitment Activity Reporting Request for Proposals Research Research Design Research Ethics Committees Research Personnel Risk Safety Sampling Studies Screening procedure Selective Serotonin Reuptake Inhibitor Severities Site Sleep Sleep disturbances Source Specific qualifier value Structure Suicide Supervision Symptoms Telephone Testing Time Training United States Universities Upper arm Work alcohol use disorder clinical research site data management depression depressive symptoms experience follow-up functional disability high standard impression improved meetings pill professor racial and ethnic response symposium treatment effect

项目摘要

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.

说明（由申请人提供）：此重新提交申请是为了对我们之前的资助 (MH060783) 进行竞争性续展，在该资助中我们确定了有针对性的复杂悲伤治疗 (CGT) 的功效。目前的申请是进行一项多中心研究，以采取下一步所需的步骤来优化遭受复杂悲伤的个人的治疗，并响应 PA-07-092 邀请资助成人精神障碍合作研究的申请。复杂性悲伤（CG）是一种使人衰弱的疾病，据估计仅在美国就影响了数百万人。我们之前的研究是第一个针对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都有更好的结果，尽管在联合（60% 响应者对 40%）或不联合（42% 对 19%）抗抑郁药时 CGT 优于 IPT。单独抗抑郁药物的研究表明，与 SSRIs 相比，结果好坏参半，似乎很有希望。然而，尚无 SSRIs 治疗 CG 的随机对照研究。确定 SSRI 治疗 CG（在联合或不联合 CGT 的情况下）的疗效对于公共卫生具有重要意义。我们召集了 4 组在丧亲研究方面拥有良好记录、在干预研究和多中心项目方面拥有丰富经验的研究人员，来开展艾司西酞普兰 (ESC) 疗效的研究。我们计划招募 440 名初步诊断为复杂悲伤超过 4.5 年的人，并随机分配他们接受 ESC、PBO、ESC + CGT 或 PBO + CGT 为期 16 周的治疗。具体目标是比较 1) ESC 与 PBO、2) ESC + CGT 与 PBO + CGT 和 3) CGT + ESC 与 ESC 在反应者状态测量以及 CG 症状、抑郁、焦虑、功能障碍、睡眠和自杀方面的改善。我们将探索中介和调节假设，以回答有关这些治疗如何发挥作用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。