Green Eric P, Pearson Nicholas, Rajasekharan Sathyanath, Rauws Michiel, Joerin Angela, Kwobah Edith, Musyimi Christine, Bhat Chaya, Jones Rachel M, Lai Yihuan
Duke Global Health Institute, Duke University, Durham, NC, United States.
Jacaranda Health, San Francisco, CA, United States.
JMIR Res Protoc. 2019 Apr 29;8(4):e11800. doi: 10.2196/11800.
Depression during pregnancy and in the postpartum period is associated with a number of poor outcomes for women and their children. Although effective interventions exist for common mental disorders that occur during pregnancy and the postpartum period, most cases in low- and middle-income countries go untreated because of a lack of trained professionals. Task-sharing models such as the Thinking Healthy Program have shown great potential in feasibility and efficacy trials as a strategy for expanding access to treatment in low-resource settings, but there are significant barriers to scale-up. We are addressing this gap by adapting Thinking Healthy for automated delivery via a mobile phone. This new intervention, Healthy Moms, uses an existing artificial intelligence system called Tess (Zuri in Kenya) to drive conversations with users.
The objective of this pilot study is to test the Healthy Moms perinatal depression intervention using a single-case experimental design with pregnant women and new mothers recruited from public hospitals outside of Nairobi, Kenya.
We will invite patients to complete a brief, automated screening delivered via text messages to determine their eligibility. Enrolled participants will be randomized to a 1- or 2-week baseline period and then invited to begin using Zuri. Participants will be prompted to rate their mood via short message service every 3 days during the baseline and intervention periods. We will review system logs and conduct in-depth interviews with participants to study engagement with the intervention, feasibility, and acceptability. We will use visual inspection, in-depth interviews, and Bayesian estimation to generate preliminary data about the potential response to treatment.
Our team adapted the intervention content in April and May 2018 and completed an initial prepilot round of formative testing with 10 women from a private maternity hospital in May and June. In preparation for this pilot study, we used feedback from these users to revise the structure and content of the intervention. Recruitment for this protocol began in early 2019. Results are expected toward the end of 2019.
The main limitation of this pilot study is that we will recruit women who live in urban and periurban centers in one part of Kenya. The results of this study may not generalize to the broader population of Kenyan women, but that is not an objective of this phase of work. Our primary objective is to gather preliminary data to know how to build and test a more robust service. We are working toward a larger study with a more diverse population.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/11800.
孕期及产后抑郁与女性及其子女的一系列不良后果相关。尽管针对孕期和产后常见精神障碍存在有效的干预措施，但在低收入和中等收入国家，由于缺乏专业培训人员，大多数病例未得到治疗。诸如“健康思考计划”等任务分担模式在可行性和疗效试验中显示出巨大潜力，可作为在资源匮乏地区扩大治疗可及性的策略，但扩大规模存在重大障碍。我们正在通过使“健康思考计划”适应通过手机自动提供服务来填补这一空白。这项新的干预措施“健康妈妈”使用名为苔丝（在肯尼亚为祖里）的现有人工智能系统与用户进行对话。
本试点研究的目的是采用单病例实验设计，对从肯尼亚内罗毕以外的公立医院招募的孕妇和新妈妈进行“健康妈妈”围产期抑郁干预测试。
我们将邀请患者通过短信完成一项简短的自动筛查，以确定其是否符合条件。入选的参与者将被随机分配到1周或2周的基线期，然后被邀请开始使用祖里。在基线期和干预期，参与者将每3天通过短信服务被提示对自己的情绪进行评分。我们将查看系统日志并对参与者进行深入访谈，以研究他们对干预措施的参与度、可行性和可接受性。我们将使用目视检查、深入访谈和贝叶斯估计来生成有关治疗潜在反应的初步数据。
我们的团队在2018年4月和5月调整了干预内容，并于5月和6月对一家私立妇产医院的10名女性进行了初步预试验阶段的形成性测试。为准备这项试点研究，我们利用这些用户的反馈意见修订了干预措施的结构和内容。该方案的招募工作于2019年初开始。预计2019年底得出结果。
这项试点研究的主要局限性在于，我们将招募居住在肯尼亚一个地区城市和城郊中心的女性。本研究结果可能不适用于更广泛的肯尼亚女性群体，但这并非此阶段工作的目标。我们的主要目标是收集初步数据，以了解如何构建和测试更强大的服务。我们正在努力开展一项针对更多样化人群的更大规模研究。
国际注册报告识别码（IRRID）：DERR1-10.2196/11800。
