Le Huynh-Nhu, Andescavage Nickie, Keller Jennifer M, Bassa Maariya M, Danielson Aimee L, Henderson Diedtra, Bond Shanae, Mjenga Nandi, Wells Stephanie, Quinn Patricia, Limperopoulos Catherine
Department of Psychological and Brain Sciences, George Washington University, Washington, DC, United States of America.
Developing Brain Institute, Department of Neonatology, Children's National Hospital, Washington, DC, United States of America.
Contemp Clin Trials Commun. 2025 Apr 21;45:101489. doi: 10.1016/j.conctc.2025.101489. eCollection 2025 Jun.
Mental health disorders, including stress, anxiety, and depression, are the most common complications during pregnancy, with significant racial disparities in prevalence and access to care. Low-income Black/African American/of African descent (Black) individuals are at greater risk for perinatal mental health issues and face more obstacles to care due to a variety of barriers, including poor implementation of screening protocols, stigma, adverse experiences of social determinants of health, and distrust of healthcare systems. These disparities are particularly striking in Washington, DC, and worsened during the COVID-19 pandemic.
This study has two aims: (1) to refine an individualized plan to integrate patient navigation and a culturally adapted cognitive-behavioral (CBT) prevention and treatment intervention for low-income Black pregnant women; and (2) to determine the effectiveness of multiple interventions: patient navigation, culturally adapted CBT, and/or peer support groups versus usual care for pregnant individuals at subthreshold and threshold risk for prenatal stress, depression and/or anxiety in a two-arm prospective longitudinal randomized controlled study. Outcomes will be tracked from pregnancy through 12 months postpartum, assessing maternal mental health, engagement with the intervention, healthcare experiences and utilization, and infant outcomes.
If found to be efficacious, results will help develop scalable, culturally relevant interventions aimed at reducing racial disparities in maternal mental health care and improving health outcomes for both mothers and infants. Trial registration: ClinicalTrials.gov ID NCT05345834.
心理健康障碍，包括压力、焦虑和抑郁，是孕期最常见的并发症，在患病率和获得护理方面存在显著的种族差异。低收入的黑人/非裔美国人/非洲裔（黑人）个体围产期心理健康问题的风险更高，并且由于各种障碍，包括筛查方案实施不佳、耻辱感、健康社会决定因素的不良经历以及对医疗系统的不信任，在获得护理方面面临更多障碍。这些差异在华盛顿特区尤为显著，在新冠疫情期间进一步恶化。
本研究有两个目标：（1）完善一项个性化计划，将患者导航与针对低收入黑人孕妇的文化适应性认知行为（CBT）预防和治疗干预相结合；（2）在一项双臂前瞻性纵向随机对照研究中，确定多种干预措施的有效性：患者导航、文化适应性CBT和/或同伴支持小组与常规护理相比，对产前压力、抑郁和/或焦虑处于亚阈值和阈值风险的孕妇的效果。从孕期到产后12个月跟踪结果，评估产妇心理健康、对干预的参与度、医疗体验和利用情况以及婴儿结局。
如果被证明有效，研究结果将有助于开发可扩展的、具有文化相关性的干预措施，旨在减少孕产妇心理健康护理方面的种族差异，并改善母婴的健康结局。试验注册：ClinicalTrials.gov标识符NCT05345834。
