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

以焦虑为重点的早期产前干预，以预防巴基斯坦常见的精神障碍

• 批准号: 9228669
• 负责人: PAMELA J SURKAN
• 金额: $ 51.72万
• 依托单位: JOHNS HOPKINS UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-07-15 至 2022-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9228669
• 关键词: Address; Affect; Anxiety; Anxiety Disorders; Birth; Budgets; Child; Clinical; Cognitive; Cognitive Therapy; Cost Effectiveness Analysis; Costs and Benefits; Coupled; Data; Decision Making; Development; Early Intervention; Effectiveness; Employee Strikes; Environment; Evaluation; Evidence based intervention; Exposure to; Fetal Growth; Future; Generalized Anxiety Disorder; Generations; Growth; Health; Health Services Accessibility; High Prevalence; Human; Infant; Interpersonal Violence; Intervention; Light; Low Birth Weight Infant; Major Depressive Disorder; Maternity Hospitals; Mediating; Mediation; Mental Depression; Mental Health; Mental disorders; Modification; Mothers; Newborn Infant; Outcome; Pakistan; Policies; Policy Maker; Population; Postpartum Depression; Postpartum Period; Poverty; Pregnancy; Pregnancy Trimesters; Pregnant Women; Premature Birth; Prevalence; Prevention; Prevention strategy; Preventive; Preventive Intervention; Primary Health Care; Provider; Public Health; Public Hospitals; Public Policy; Randomized; Randomized Controlled Trials; Research; Resource Allocation; Resources; Risk Factors; Second Pregnancy Trimester; Sex Discrimination; Small for Gestational Age Infant; Social support; Stress; Symptoms; Testing; Therapeutic Intervention; Time; Woman; Work; anxiety reduction; anxiety symptoms; base; caregiving; cost; cost-effectiveness evaluation; economic cost; evidence base; evidence based guidelines; experience; fetal; health care service utilization; improved; infant outcome; innovation; intervention effect; low and middle-income countries; low income country; maternal anxiety; maternal depression; neglect; offspring; perinatal outcomes; peripartum depression; postnatal; prenatal; prenatal intervention; prevent; programs; psychosocial; randomized trial; resilience; scale up; secondary analysis; secondary outcome; social; stressor; success; therapy development; treatment as usual

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.

摘要：妊娠期频繁发生焦虑、抑郁等常见精神障碍 (CMD) 以及中低收入国家 (LMIC) 的产后期。产前焦虑，均低于阈值 和临床，对母亲的健康和后代的结果产生不利影响，并且是一个主要的预测因素 随后的抑郁症。预防方法具有减少负面影响的巨大潜力 母亲产后精神障碍并改善儿童结局。我们建议创建一个可扩展且 可持续的早期预防干预措施，重点关注孕妇的焦虑症状，由 非专业提供者（目标 1）。我们将通过随机试验来评估这种预防性干预措施 巴基斯坦伊斯兰堡一家公立医院的 1100 名孕妇接受了我们的认知行为治疗- 基于（CBT）的早期妊娠计划或常规护理。我们将研究干预措施的效果 1) 妊娠第 3 个月和产后 6 周的 CMD（目标 2）以及 2) 胎儿和新生儿 小于胎龄 (SGA) 的结果（目标 3）。我们还将检查人际暴力是否被感知 压力和社会支持调节和/或改变对 CMD 和围产期结局的干预效果（目标 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 产前干预和加强常规护理组中的妇女（目标 5）。 专注于减少焦虑是一项重大创新；产前焦虑尚未得到解决 中低收入国家的干预方案，尽管它与产后抑郁症增加和次优相关 胎儿和婴儿的结局。巴基斯坦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 的方法适合 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，我们 此前已成功减少产后抑郁症。怀孕早期干预是进一步 对于建立减少孕产妇 CMD 预防方法的证据基础至关重要的创新 以及相关的围产期结局。我们提出的中介和效果修改分析将得到改善 了解行动机制并帮助确定计划目标的亚人群。用途 非专业提供者的数量以及初级保健环境中的整合将指导扩大规模，同时 纳入成本效益分析将有助于决策者做出资源分配决策。 这项研究将有助于将针对焦虑的预防策略与现有的焦虑方法相结合。 治疗围产期抑郁症，以进一步为跨诊断心理健康举措提供证据基础 全球范围内，并将为支持终身孕产妇心理健康和几代人的复原力的政策提供信息。