Microgen Laboratories LLC, La Marque, Tx, USA.
The Ohio State University, Columbus, Ohio, USA.
BMC Pregnancy Childbirth. 2022 Dec 28;22(1):979. doi: 10.1186/s12884-022-05284-9.
Pregnant Mexican Americans (hereafter called Latinas) and Black/African American women are at increased risk for psychological distress, contributing to preterm birth and low birthweight; acculturative stress combined with perceived stress elevates depressive symptoms in Latinas. Based on our prior research using a psychoneuroimmunology framework, we identified psychological and neuroendocrine risk factors as predictors of preterm birth in Latina women that are also identified as risk factors for Black/African American women.
METHODS/DESIGN: In this prospective, randomized controlled trial with parallel group design we will explore psychosocial, neuroendocrine, and birth outcome effects of the Mastery Lifestyle Intervention (MLI). The MLI is a culturally relevant, manualized, psychosocial, group intervention integrating two cognitive behavioral therapies for both pregnant Latinas and Black/African American women (total n = 221). Study inclusion criteria are: women with current pregnancy at 14-20 weeks gestation, ability to read and speak English or Spanish, self-identify as Latina of Mexican heritage or Black/African American, 18-45 years old, born in the US or Mexico, and currently living in the US. Participants must receive Medicaid or other government-supported insurance, and meet screening criteria for anxiety, depressive symptoms, or stress. Participants are randomly assigned to either the intervention (MLI) or usual care group (UCG) in groups of 6-8 participants that occur over 6 consecutive weeks. Data are collected at 3 time points: enrollment (14-20 weeks gestation), following treatment (20-26 weeks), and 6 weeks after treatment (32-36 weeks gestation). Additional outcome, mediating, and moderating data are collected from the electronic health record during pregnancy and at birth. Analyses will primarily use generalized linear mixed modeling (GLMM) to evaluate the relationships between predictors and outcomes.
This RCT will test the efficacy of two combined third generation cognitive behavioral therapies (the MLI), given in a group format over 6 sessions, as compared to a usual prenatal care group, for both Latina and African American pregnant women. If efficacious, it may be provided as an adjunct to routine prenatal care and improve mental health, as well as babies being born too small and too soon.
The trial was retrospectively registered at ClinicalTrials.gov . Bethesda (MD): National Library of Medicine. Identifier NCT05012072 , Reducing Pregnancy Risks: The Mastery Lifestyle Intervention (MLI); August 19, 2021. The trial is currently recruiting participants.
墨西哥裔美国孕妇（后文简称拉丁裔）和非裔美国黑人女性患心理困扰的风险增加，这会导致早产和低出生体重；文化适应压力加上感知压力会使拉丁裔女性的抑郁症状加重。基于我们之前使用心理神经免疫学框架的研究，我们确定了心理和神经内分泌风险因素，这些因素可以预测拉丁裔女性的早产，也被认为是非裔美国黑人女性的风险因素。
方法/设计：在这项前瞻性、随机对照试验中，我们将采用平行分组设计来探索掌控生活方式干预（MLI）对心理社会、神经内分泌和分娩结局的影响。MLI 是一种文化相关的、标准化的心理社会小组干预措施，将两种认知行为疗法整合在一起，适用于怀孕的拉丁裔和非裔美国黑人女性（共 221 名）。研究纳入标准为：处于 14-20 孕周妊娠的当前妊娠妇女、能够阅读和说英语或西班牙语、自我认同为墨西哥裔的拉丁裔或非裔美国黑人、18-45 岁、出生于美国或墨西哥、目前居住在美国。参与者必须接受医疗补助或其他政府支持的保险，并符合焦虑、抑郁症状或压力的筛查标准。参与者按 6-8 人的小组随机分配至干预组（MLI）或常规护理组（UCG），每组持续 6 周。数据在 3 个时间点收集：入组时（14-20 孕周）、治疗后（20-26 孕周）和治疗后 6 周（32-36 孕周）。在妊娠期间和分娩时，从电子健康记录中收集其他结局、中介和调节数据。分析主要使用广义线性混合模型（GLMM）来评估预测因素与结局之间的关系。
这项 RCT 将测试两种联合第三代认知行为疗法（MLI）的疗效，这些疗法以小组形式在 6 个疗程中提供，与常规产前护理组相比，适用于拉丁裔和非裔美国的孕妇。如果有效，它可以作为常规产前护理的辅助手段，改善心理健康，以及避免婴儿出生时体重过轻和早产。
该试验在 ClinicalTrials.gov 进行了回顾性注册。贝塞斯达（马里兰州）：美国国立医学图书馆。标识符 NCT05012072，降低妊娠风险：掌控生活方式干预（MLI）；2021 年 8 月 19 日。该试验正在招募参与者。
