An anxiety-focused early prenatal intervention for the prevention of common mental disorders in Pakistan

摘要：常见的精神障碍（CMD），如焦虑和抑郁，经常发生在怀孕期间 低收入和中等收入国家（LMIC）的产后期。产前焦虑，均低于阈值 和临床，不利地影响产妇的福祉和后代的结果，是一个主要的预测因素， 随后的抑郁症预防性办法具有巨大的潜力，可以减少 产后精神障碍的母亲和改善儿童的结果。我们建议创建一个可扩展的， 可持续的早期预防干预，重点是孕妇的焦虑症状，将由 非专科医生（目标1）。我们将通过一项随机试验来评估这种预防性干预措施。 1100名孕妇从巴基斯坦伊斯兰堡的一家公立医院来到我们的认知行为疗法- 基于CBT的早期妊娠计划或常规护理。我们将研究干预的效果 1）妊娠晚期和产后6周的CMD（目标2）和2）胎儿和新生儿 小于胎龄儿（SGA）结局（目标3）。我们还将研究人际暴力， 压力和社会支持介导和/或改变干预对CMD和围产期结局的影响（Aim 4）。最后，我们将进行成本效益评估，比较成本和医疗保健利用率， 产前干预和加强日常护理小组中的妇女（目标5）。 关注减少焦虑是一项重大创新;产前焦虑尚未得到解决。 在中低收入国家的干预包，尽管它与增加产后抑郁症和次优 胎儿和婴儿的结果。巴基斯坦的产前焦虑症患病率很高（35%至49%） 和SGA新生儿（~47%），提供了理想的研究机会。我们基于CBT的方法， 考虑到它对焦虑和抑郁的指示，是基于我们在这一人群中的初步工作， 曾成功减少产后抑郁症。在怀孕早期进行干预是一个进一步的 创新对于建立减少孕产妇CMD预防方法的证据基础至关重要 和相关的围产期结局。我们建议的调解和效果修改分析将改善 了解行动机制，并帮助确定方案目标群体。使用 非专业服务提供者和初级保健环境内的一体化将指导扩大规模， 纳入成本效益分析将有助于决策者作出资源分配决定。 这项研究将告知整合的预防策略，目标是焦虑与现有的方法， 治疗围产期抑郁症，以促进跨诊断精神卫生倡议的证据基础 全球范围内，并将告知政策，以支持终身孕产妇心理健康和跨代复原力。

SUMMARY: Common mental disorders (CMDs) such as anxiety and depression occur frequently in pregnancy and the postnatal period in lower- and middle income countries (LMICs). Prenatal anxiety, both subthreshold and clinical, adversely affects maternal wellbeing and outcomes among offspring, and is a major predictor of subsequent depression. Preventive approaches have enormous potential to reduce the negative effects of postnatal mental disorders in mothers and improve child outcomes. We propose to create a scalable and sustainable early prevention intervention focusing on anxiety symptoms in pregnant women, to be delivered by non-specialist providers (Aim 1). We will evaluate this preventive intervention through a trial by randomizing 1100 pregnant women from a public hospital in Islamabad Pakistan to either our Cognitive Behavioral Therapy- based (CBT-based) early-in-pregnancy program or to usual care. We will study the effects of the intervention on 1) CMDs in the 3rd trimester of pregnancy and at 6 weeks postpartum (Aim 2) and on 2) fetal and newborn small-for-gestational age (SGA) outcomes (Aim 3). We will also examine if interpersonal violence, perceived stress and social support mediate and/or modify the intervention effects on CMDs and perinatal outcomes (Aim 4). Finally, we will conduct a cost-effectiveness evaluation, comparing costs and healthcare utilization for women in the prenatal intervention and enhanced usual care groups (Aim 5). Focusing on anxiety reduction is a major innovation; anxiety has not been addressed within prenatal intervention packages in LMICs, despite its association with increased postpartum depression and suboptimal fetal and infant outcomes. Pakistan has high prevalence of both women with prenatal anxiety (35% to 49%) and SGA newborns (~47%), providing an ideal research opportunity. Our CBT-based approach, appropriate given its indication for anxiety and depression, is grounded in our preliminary work in this population, where we have previously successfully reduced postpartum depression. Intervening early in pregnancy is a further innovation that is critical for building the evidence base for preventative approaches to reduce maternal CMDs and related perinatal outcomes. Our proposed mediation and effect modification analyses will improve understanding of mechanism(s) of action and help identify subpopulations for programmatic targeting. The use of non-specialized providers and integration within the primary care environment will guide scale up, while incorporating a cost-effectiveness analysis will aid policy-makers in resource allocation decisions. This study will inform the integration of preventive strategies that target anxiety with existing approaches for treatment of perinatal depression to further the evidence-base for transdiagnostic mental health initiatives globally, and will inform policies to support lifelong maternal mental health and resilience across generations.