Reductions in biopsychosocial risks for pregnant Latinas and their infants: the Mastery Lifestyle Intervention

项目概要/摘要 怀孕的墨西哥裔美国妇女（西班牙裔妇女的最大亚组），下文 被称为拉丁裔，是在增加风险的心理困扰，导致不利的 出生结局，如早产（PTB，胎龄< 37周）和低出生体重 (LBW<2500克）。我们之前的研究，使用心理神经免疫学（PNI）框架， 已经确定了心理风险因素（抑郁症状，焦虑，压力，应对）， 神经内分泌风险因素（高促肾上腺皮质激素释放激素[CRH]，低孕酮， 高雌三醇）作为拉丁妇女PTB的强预测因子。新 需要确定和严格测试针对这些风险因素的干预措施。解决 针对拉丁美洲人的干预措施存在的差距，我们已经制定并成功地进行了试点测试， 掌握生活方式干预（MLI）：一个文化相关的，手动的心理社会小组 整合两种循证行为疗法的干预-接受和 承诺疗法（ACT）和问题解决疗法（PST）。MLI是一个为期6周的项目， 旨在纳入定期产前护理，以促进更全面的护理 由执业护士（NP）或注册护士助产士（CNM）接生。我们建议 随机对照试验的以下目的：主要目的1：确定 MLI在怀孕的拉丁妇女，以减少抑郁症状，焦虑，感知和 与常规护理（UC）相比，从基线（14-20 妊娠20-26周）至治疗结束（妊娠20-26周）和6周随访时（妊娠26-32周） 周妊娠），与文化适应和心理灵活性作为调解人。探索性目标 2：探讨MLI对PTB神经内分泌危险因素（CRH，孕酮， 雌三醇）与UC之间的差异。探索性目标3：探索 MLI对婴儿出生结局（胎龄、出生体重、NICU入院）的影响。的分析 每个假设都将依赖于具有随机效应的广义线性混合模型（GLMM）， 参与者和必要的时间来解释相关的观察结果。纵向分析 将每个结果建模为治疗组、时间和 治疗组和时间。我们还将使用SEM来分析介质。 我们期望多边工具将提供一个迫切需要的，新颖的，可行的，有效的， 非药理学程序添加到治疗工具箱中，帮助提供者改善 怀孕期间的健康嵌入到产前护理，它的目标是心理困扰， 怀孕的拉丁裔妇女，一个得不到充分服务的群体它可以大大降低风险， 出生结果不佳，从而减少对母亲和婴儿的长期破坏性影响。

Project Summary/Abstract Pregnant Mexican-American women (the largest subgroup of Hispanic women), hereafter referred to as Latinas, are at increasing risk for psychological distress which leads to adverse birth outcomes such as preterm birth (PTB, gestational age < 37 weeks) and low birthweight (LBW, <2500 grams). Our prior research, using a psychoneuroimmunology (PNI) framework, has identified psychological risk factors (depressive symptoms, anxiety, stress, coping) and neuroendocrine risk factors (high Corticotropin Releasing Hormone [CRH], lower progesterone, higher estriol) at 22-24 weeks gestation as strong predictors of PTB in Latina women. New interventions targeting these risk factors need to be identified and rigorously tested. To address the gaps related to interventions for Latinas, we have developed and successfully pilot tested the Mastery Lifestyle Intervention (MLI): a culturally-relevant, manualized psychosocial group intervention that integrates two evidence-based behavioral therapies – Acceptance and Commitment Therapy (ACT) and Problem-Solving Therapy (PST). The MLI is a 6-week program designed to be integrated into regular prenatal care to facilitate more comprehensive care delivered by a nurse practitioner (NP) or certified nurse midwife (CNM). We propose the following aims for a randomized controlled trial: Primary Aim 1: Determine the efficacy of the MLI in pregnant Latina women to decrease depressive symptoms, anxiety, perceived and acculturative stress, and to improve coping, versus usual care (UC), from baseline (14-20 weeks gestation) to end-of-treatment (20-26 weeks gestation) and at a 6 week follow-up (26-32 weeks gestation), with acculturation and psychological flexibility as mediators. Exploratory Aim 2: Explore the effect of the MLI on neuroendocrine risk factors of PTB (CRH, progesterone, and estriol) versus UC from baseline to end-of treatment. Exploratory Aim 3: Explore the effect of the MLI on infant birth outcomes (gestational age, birthweight, NICU admission). Analyses for each hypothesis will rely on generalized linear mixed modeling (GLMM) with random effects for participant and time as necessary to account for correlated observations. Longitudinal analyses will model each outcome as a function of treatment group, time, and the interaction between treatment group and time. We will also use SEM to analyze for mediators. We expect the MLI will provide a greatly needed, novel, feasible, and effective nonpharmacological program added to the toolbox of treatments assisting providers to improve health during pregnancy. Embedded into prenatal care, it targets psychological distress among pregnant Latina women, an underserved population. It may substantially reduce the risks for poor birth outcomes, thus reducing devastating and long-term effects for both mother and infant.