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

摘要：常见精神障碍(CMD)，如焦虑和抑郁，常见于妊娠期 低收入和中等收入国家(LMIC)的出生后时期。产前焦虑，两者都在临界值以下 和临床上，对母亲的福祉和后代的结局产生不利影响，并且是 随之而来的抑郁。预防方法具有巨大的潜力，可以减少 减少母亲的产后精神障碍，改善孩子的结局。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，由 非专业提供者(目标1)。我们将通过随机试验来评估这一预防性干预措施。 巴基斯坦伊斯兰堡一家公立医院的1100名孕妇接受我们的认知行为疗法- 基于(基于CBT的)怀孕早期计划或常规护理。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(SGA)结局(目标3)。我们还将研究人际暴力，感知到 压力和社会支持调节和/或改变对CMD和围产儿结局的干预效果 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 产前干预组和加强日常护理组的妇女(目标5)。 专注于减少焦虑是一项重大创新；焦虑还没有在产前得到解决 LMICs中的干预包，尽管它与产后抑郁增加和次优相关 胎儿和婴儿的结局。巴基斯坦有很高的产前焦虑症患病率(35%到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，适当 鉴于其焦虑和抑郁的迹象，是基于我们在这一人群中的初步工作，在那里我们 之前已经成功地减少了产后抑郁症。在怀孕早期进行干预是进一步的 对于为减少孕产妇慢性精神疾病的预防性方法建立证据基础至关重要的创新 以及相关的围产期结局。我们建议的调解和效果修改分析将会改进 了解行动机制(S)，并帮助确定规划目标的亚群。它的用途 非专科提供者和初级保健环境中的整合将指导扩大规模，而 纳入成本效益分析将有助于政策制定者做出资源分配决策。 这项研究将提供针对焦虑的预防策略与现有方法的整合 围产期抑郁症的治疗以促进跨诊断心理健康倡议的证据基础 在全球范围内，并将为支持终身产妇心理健康和世代复原力的政策提供信息。

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.