University of Massachusetts Medical School, 55 Lake Avenue, Worcester, MA, 01655, USA.
Department of Obstetrics and Gynecology, University of Massachusetts Medical School, 119 Belmont Street, Worcester, MA, 01605, USA.
BMC Pregnancy Childbirth. 2019 Jul 22;19(1):256. doi: 10.1186/s12884-019-2387-3.
Perinatal depression, the most common pregnancy complication, is associated with negative maternal-offspring outcomes. Despite existence of effective treatments, it is under-recognized and under-treated. Professional organizations recommend universal screening, yet multi-level barriers exist to ensuring effective diagnosis, treatment, and follow-up. Integrating mental health and obstetric care holds significant promise for addressing perinatal depression. The overall study goal is to compare the effectiveness of two active interventions: (1) the Massachusetts Child Psychiatry Access Program (MCPAP) for Moms, a state-wide, population-based program, and (2) the PRogram In Support of Moms (PRISM) which includes MCPAP for Moms plus a proactive, multifaceted, practice-level intervention with intensive implementation support.
This study is conducted in two phases: (1) a run-in phase which has been completed and involved practice and patient participant recruitment to demonstrate feasibility for the second phase, and (2) a cluster randomized controlled trial (RCT), which is ongoing, and will compare two active interventions 1:1 with ten Ob/Gyn practices as the unit of randomization. In phase 1, rates of depressive symptoms and other demographic and clinical features among patients were examined to inform practice randomization. Patient participants to be recruited in phase 2 will be followed longitudinally until 13 months postpartum; they will have 3-5 total study visits depending on whether their initial recruitment and interview was at 4-24 or 32-40 weeks gestation, or 1-3 months postpartum. Sampling throughout pregnancy and postpartum will ensure participants with different depressive symptom onset times. Differences in depression symptomatology and treatment participation will be compared between patient participants by intervention arm.
This manuscript describes the full two-phase study protocol. The study design is innovative because it combines effectiveness with implementation research designs and integrates critical components of participatory action research. Our approach assesses the feasibility, acceptance, efficacy, and sustainability of integrating a stepped-care approach to perinatal depression care into ambulatory obstetric settings; an approach that is flexible and can be tailored and adapted to fit unique workflows of real-world practices.
ClinicalTrials.gov Identifier: NCT02760004, registered prospectively on May 3, 2016.
围产期抑郁症是最常见的妊娠并发症，与母婴不良结局有关。尽管有有效的治疗方法，但它的识别和治疗仍不足。专业组织建议进行普遍筛查，但在确保有效诊断、治疗和随访方面存在多层次障碍。将心理健康和产科护理相结合，为解决围产期抑郁症提供了很大的希望。总体研究目标是比较两种积极干预措施的效果：（1）马萨诸塞州儿童精神病学准入计划（MCPAP）为妈妈们，这是一个全州性的、基于人群的计划，（2）支持妈妈计划（PRISM），包括 MCPAP 为妈妈们，以及一个积极的、多方面的、实践层面的干预措施，具有强化实施支持。
本研究分两个阶段进行：（1）已完成的预试验阶段，涉及实践和患者参与者的招募，以证明第二阶段的可行性，（2）正在进行的集群随机对照试验（RCT），将 10 个妇产科实践作为随机分组单位，比较两种积极干预措施 1:1。在第 1 阶段，根据实践随机化情况，检查患者的抑郁症状和其他人口统计学及临床特征的发生率。第 2 阶段将招募患者参与者进行纵向随访，直到产后 13 个月；根据他们的初始招募和访谈是在 4-24 周还是 32-40 周妊娠，或 1-3 个月产后，他们将进行 3-5 次总研究访视。整个孕期和产后的抽样将确保参与者有不同的抑郁症状发作时间。将根据干预组比较患者参与者的抑郁症状学和治疗参与差异。
本手稿描述了完整的两阶段研究方案。该研究设计具有创新性，因为它结合了有效性和实施研究设计，并整合了参与式行动研究的关键组成部分。我们的方法评估了将一种针对围产期抑郁症的阶梯式护理方法纳入门诊产科环境的可行性、可接受性、疗效和可持续性；这种方法具有灵活性，可以根据实际实践的独特工作流程进行调整和适应。
ClinicalTrials.gov 标识符：NCT02760004，于 2016 年 5 月 3 日前瞻性注册。
