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.

描述（由申请人提供）：此重新提交申请是用于我们先前的赠款（MH060783）的竞争续订，在该授权中，我们确定了目标复杂的悲伤待遇（CGT）的功效。当前的应用是进行一项多中心研究，以采取为患有复杂悲伤的人提供优化治疗所需的下一步，并对PA-07-092做出邀请拨款申请，以供成人精神障碍协作研究。复杂的悲伤（CG）是一种令人衰弱的状况，估计仅会影响美国数百万人。我们先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）时继续稳定抗抑郁药。服用抗抑郁药的个体在两种治疗中都有更好的结果，尽管CGT在使用（60％响应者v。40％）或没有（42％v。19％）抗抑郁药时优于IPT。单独的抗抑郁药的研究显示，SSRI的结果混合了，似乎很有希望。但是，CG的SSRIS没有随机对照研究。确定SSRI治疗对CG的疗效，如果有或没有CGT，则具有很大的公共健康重要性。我们已经组建了4组研究人员，在丧亲研究中具有很强的记录，并在干预研究和多中心项目中进行了丰富的经验，以对Escitalopram（ESC）疗效进行研究。我们计划在4。5年内招募440人，主要诊断为复杂的悲伤，并随机分配他们接受ESC，PBO，ESC + CGT或PBO + CGT的16周治疗。具体目的是比较1）ESC V PBO，2）ESC + CGT V PBO + CGT和3）CGT + ESC V ESC在响应者状态的措施以及CG症状，抑郁症，焦虑，功能障碍，睡眠和自杀性方面的改善。我们将探索调解人和主持人假设，以回答有关这些治疗方法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。