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

降低拉丁裔孕妇及其婴儿的生物心理社会风险：掌握生活方式干预

基本信息

批准号：
10117401
负责人：
Roberta Jeanne Ruiz
金额：
$ 64.34万
依托单位：
MICROGEN, LLC
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-04-08 至 2026-02-28
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10117401
关键词：
Acculturation Address Admission activity American Anxiety Behavior Therapy Biological Birth Caproates Cervical Cerclage Child Clinical Cognitive Therapy Comprehensive Health Care Corticotropin-Releasing Hormone Depressed mood Diagnosis Discipline of obstetrics Estriol Gestational Age Gynecology Health Hispanics Hormonal Hydroxyprogesterone Infant Intervention Latina Long-Term Effects Low Birth Weight Infant Mediating Mediator of activation protein Medical Mental Depression Mexican Americans Mission Modeling Mothers National Institute of Child Health and Human Development Neurosecretory Systems Nurse Midwives Nurse Practitioners Outcome Participant Pharmaceutical Preparations Pilot Projects Population Postpartum Depression Pregnancy Premature Birth Prenatal care Progesterone Provider Psychological Stress Psychoneuroimmunology Public Health Randomized Controlled Trials Reporting Research Risk Risk Factors Stress Stress and Coping Subgroup Testing Time Underserved Population United States Woman Work adverse birth outcomes antepartum depression base biopsychosocial care providers college coping depressive symptoms design early pregnancy effectiveness testing evidence base flexibility follow-up group intervention health disparity improved innovation intervention participants lifestyle intervention longitudinal analysis novel perceived stress pregnant premature prenatal health prevent problem solving therapy programs psychologic psychological distress psychosocial response screening treatment as usual treatment group

项目摘要

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.

项目概要/摘要墨西哥裔美国孕妇（西班牙裔女性中最大的一个群体），以下简称被称为拉丁裔的人，遭受心理困扰的风险越来越大，从而导致不利的影响出生结局，例如早产（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，已确定心理危险因素（抑郁症状、焦虑、压力、应对）神经内分泌危险因素（促肾上腺皮质激素释放激素 [CRH] 高、黄体酮低、妊娠 22-24 周时较高的雌三醇）是拉丁裔女性 PTB 的强预测因子。针对这些风险因素需要进行识别和严格测试来解决。与拉丁裔干预措施相关的差距，我们已经开发并成功进行了试点测试掌握生活方式干预（MLI）：一个与文化相关的、手动的心理社会团体整合两种基于证据的行为疗法的干预措施——接受和承诺疗法 (ACT) 和问题解决疗法 (PST) 是一个为期 6 周的计划。旨在融入常规产前护理，以促进更全面的护理由执业护士 (NP) 或认证护士助产士 (CNM) 提供。随机对照试验的目标如下：主要目标 1：确定 MLI 可以减少拉丁裔孕妇的抑郁症状、焦虑、感知和抑郁症状与常规护理（UC）相比，从基线（14-20 妊娠周）到治疗结束（妊娠 20-26 周）以及 6 周随访时（妊娠 26-32 周）妊娠周），以文化适应和心理灵活性作为探索性目标。 2：探讨MLI对PTB神经内分泌危险因素（CRH、黄体酮和雌三醇）与 UC 从基线到治疗结束的比较探索性目标 3：探索 UC 的效果。 MLI 对婴儿出生结局（胎龄、出生体重、新生儿重症监护室 (NICU) 入院）的分析。每个假设将依赖于具有随机效应的广义线性混合模型 (GLMM) 考虑相关观察所需的参与者和时间。将每个结果建模为治疗组、时间和之间相互作用的函数我们还将使用 SEM 来分析中介因素。我们期望 MLI 能够提供急需的、新颖的、可行的、有效的非药物方案添加到治疗工具箱中，帮助提供者改善怀孕期间的健康纳入产前护理，针对心理困扰。怀孕的拉丁裔妇女是服务不足的人群，这可能会大大降低风险。不良的出生结果，从而减少对母亲和婴儿的破坏性和长期影响。