Perinatal Depression

围产期抑郁症

• 批准号: 8020764
• 负责人: GREGORY G SIMON
• 金额: $ 5.31万
• 依托单位: KAISER FOUNDATION HEALTH PLAN OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-09-24 至 2013-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8020764
• 关键词: Acute; Address; Adherence; Adult; Antidepressive Agents; Behavior Therapy; Behavioral; Birth; Brief Psychotherapy; Caring; Cognitive; Cognitive Therapy; Complex; Data; Depressed mood; Depression screen; Effectiveness; Exposure to; Face; Female of child bearing age; Fetus; General Population; Health Personnel; Healthcare; Infant; Internet; Intervention; Low Birth Weight Infant; Low income; Mails; Medical Records; Mental Depression; Mental Health; Methods; Modeling; Mothers; Outcome; Perinatal; Persons; Pharmaceutical Preparations; Pharmacological Treatment; Pharmacotherapy; Phase; Postpartum Depression; Postpartum Period; Pregnancy; Pregnant Women; Premature Birth; Prevalence; Provider; Psychotherapy; Public Health; Publishing; Randomized; Randomized Clinical Trials; Relapse; Research; Review Literature; Risk; Risk Factors; Sample Size; Sampling; Site; Stress; Structure; Surveys; Telephone; Testing; Training; Visit; Voice; Woman; Work; adverse outcome; base; comparative effectiveness; cost; effective therapy; effectiveness research; effectiveness trial; evidence base; fetal; in utero; innovation; medical specialties; neonatal exposure; novel; offspring; pilot trial; placebo controlled study; point of care; population based; preference; psychologic; psychosocial; response; routine care; standard of care; volunteer

1. Public health importance of depression in pregnancy. Women of childbearing age are the demographic group at greatest risk for onset and prevalence of depression. Depression is especially common during pregnancy (1), and perinatal depression is a robust risk factor for postpartum depression (2). In addition to the major personal and societal impacts of depression in general, depression during pregnancy is associated with a wide range of negative outcomes for both mothers and infants (3). 2. Concerns Regarding Antidepressant Treatment in Pregnancy. Although antidepressant medication is frequently prescribed to treat depression in pregnancy (4, 5), there are important limitations to pharmacotherapy for perinatal depression. For example, two studies from MHRN sites have used medical records data to examine birth outcomes among infants exposed to antidepressants in utero, finding significantly increased risk for premature delivery, low birth weight, and perinatal complications (6, 7). Many women are reluctant to start or continue antidepressant medications due to concern about impact on the fetus (8). Many pregnant women disconfinue antidepressants, leading to a high rate of depression relapse (9). Pregnant women and their care providers considering antidepressant treatment must weigh the potential benefits of treating depression against the potential risks of neonatal exposure to antidepressants (10). 3. Efficacy and Transportability of Brief Psychotherapies. In contrast, psychological or behavioral interventions offer the promise of efficacy without the concerns regarding fetal or infant exposure to medications (11). Cognitive behavior therapy has been most widely investigated psychotherapy for depression, with recent research suggesting that the simple behavioral component (behavioral activation; BA) demonstrates benefit with respect to pharmacotherapy. In a recent placebo controlled trial conducted by Co-I Dimidjian and colleagues, BA, as compared to pharmacotherapy, was found to have comparable acute phase depression outcomes, superior rates of adherence to care, and enduring benefit following treatment terminafion (12, 13). These results are especially encouraging given that the BA approach may be more easily disseminated outside of specialty mental health care (14). Simon and colleagues also showed that a related intervention (including behavioral activation and brief cognitive re-structuring) was demonstrated to be an effective treatment for depression when delivered in a novel telephone based format (15, 16). 4. Inadequate Evidence Base for Psychological Treatment of Perinatal Depression. There is a surprising paucity of research examining non-pharmacological interventions among depressed pregnant women. In fact, only two randomized clinical trials in the US have been published (17, 18). Findings were promising; however, both were limited by small sample size and restriction of entry to low income women. Available data are not adequate to guide treatment decisions forthe general population of pregnant women with depression. 5. Pressing Need for Effectiveness Research. Research to inform pafients' and providers' decisions regarding depression treatment during pregnancy must consider overall effectiveness rather than simple efficacy. While pregnant women with depression may express a preference for psychotherapy over medication (see Preliminary Studies below), the stresses and competing priorities of pregnancy and postpartum create significant barriers to participation in traditional mental health treatments. Research must address the question "Will this treatment prove acceptable and effective when delivered by real-worid providers to typical pafients treated in everyday practice settings?" rather than "Will this treatment prove efficacious when delivered by research clinicians to highly motivated volunteers seeking treatment through a research center?" 6. Summary and Study Rationale. The significance of the proposed project, thus, is supported by four key points as evident in the literature reviewed here and in our own work (Preliminary Studies). Specifically, 1) untreated antenatal depression has serious adverse consequences for women and their offspring, 2) pharmacotherapy, the current standard of care, presents women and their care providers with complex riskbenefit decisions, 3) BA and related non-pharmacological treatments have demonstrated efficacy among depressed adults and are transportable to routine care settings, and 4) few studies have examined such intervenfions with pregnant women. The proposed MHRN provides an ideal setting in which to test innovative interventions for depressed pregnant women.

1.妊娠期抑郁症的公共卫生重要性。育龄妇女是抑郁症发病和流行风险最大的人口统计学群体。抑郁症在怀孕期间特别常见（1），围产期抑郁症是产后抑郁症的一个强大的风险因素（2）。除了一般抑郁症的主要个人和社会影响外，怀孕期间的抑郁症还与母亲和婴儿的广泛负面结果有关（3）。 2.关于妊娠期抗抑郁治疗的担忧。虽然抗抑郁药物经常被用于治疗妊娠期抑郁症（4，5），但药物治疗围产期抑郁症有重要的局限性。例如，来自MHRN网站的两项研究使用医疗记录数据来检查子宫内暴露于抗抑郁药的婴儿的出生结果，发现早产，低出生体重和围产期并发症的风险显着增加（6，7）。由于担心对胎儿的影响，许多妇女不愿意开始或继续服用抗抑郁药物 （八）、许多孕妇禁用抗抑郁药，导致抑郁症复发率很高（9）。 考虑抗抑郁治疗的孕妇及其护理人员必须权衡治疗抑郁症的潜在益处与新生儿暴露于抗抑郁药的潜在风险（10）。 3.短期心理治疗的有效性和可移植性。相比之下，心理或行为干预提供了疗效的承诺，而无需担心胎儿或婴儿暴露于药物（11）。认知行为疗法是抑郁症最广泛研究的心理疗法，最近的研究表明，简单的行为成分（行为激活; BA）显示出药物治疗的益处。在Co-I Dimidjian及其同事最近进行的一项安慰剂对照试验中，发现BA与药物治疗相比具有相当的急性期抑郁结局、上级护理依从率以及治疗终止后的持久获益（12，13）。这些结果特别令人鼓舞，因为BA方法可能更容易在专业精神卫生保健之外传播（14）。Simon及其同事还表明，相关干预（包括行为激活和短暂的认知重构）被证明是一种有效的治疗抑郁症的方法，当以一种新的基于电话的形式提供时（15，16）。 4.心理治疗围产期抑郁症的证据基础不足。令人惊讶的是，关于抑郁症孕妇非药物干预的研究很少。事实上，只有两个随机临床试验在美国已出版（17，18）。调查结果是有希望的，但两者都受到样本量小和限制进入低收入妇女的限制。现有的数据不足以指导抑郁症孕妇的一般人群的治疗决策。 5.迫切需要有效性研究。研究告知pafients'和供应商的决定，关于抑郁症治疗在怀孕期间必须考虑整体的有效性，而不是简单的疗效。虽然患有抑郁症的孕妇可能会表示更喜欢心理治疗而不是药物治疗（见下文的初步研究），但怀孕和产后的压力和相互竞争的优先事项会造成 参与传统心理健康治疗的重大障碍。研究必须解决这样一个问题：“当现实世界的提供者在日常实践中向典型的病人提供这种治疗时，这种治疗是否被证明是可接受的和有效的？而不是“当临床研究人员将这种治疗方法提供给通过研究中心寻求治疗的高度积极的志愿者时，这种治疗方法是否有效？”" 6.总结和研究依据。因此，在这里回顾的文献和我们自己的工作（初步研究）中，四个关键点明显支持了拟议项目的意义。具体而言，1）未经治疗的产前抑郁症对妇女及其后代具有严重的不良后果，2）药物治疗，目前的护理标准，为妇女及其护理提供者提供了复杂的风险-受益决定，3）BA和相关的非药物治疗已证明在 抑郁的成年人，并可转移到常规护理机构，和4）很少有研究探讨这种干预与孕妇。拟议的MHRN提供了一个理想的环境，在其中测试抑郁症孕妇的创新干预措施。