Ecological Momentary Assessment of Posttraumatic Stress Disorder and Prenatal Bonding Predicting Opioid Use Disorder Relapse Among Pregnant Women

这项重新提交的申请回应了PA-18-602，并试图在日常基础上确定在怀孕期间，创伤后应激障碍(PTSD)症状与阿片类药物使用障碍(OUD)复发之间的关系，这是研究中的一个根本差距。建立了一个理论框架，将产前结合和阿片类药物渴求确定为中心创伤后应激障碍/复发关系的中介，情绪调节和焦虑敏感性作为调节因素。这将是第一次研究孕妇再次吸食毒品的风险和保护因素的时间消长，因此，这项研究推进了更常见的情况，即研究使用固定的评估，调查患有各种物质使用障碍(Sud)的孕妇。这是一个很好的模型，因为孕妇有独特的特征，这些特征随着时间的推移而变化，可能与复发有关。他们有很高的创伤后应激障碍(复发风险因素和常见的OUD共病)，而创伤后应激障碍线索会引发渴望，从而触发复发。重要的是，孕妇有一个独特的相关生物变量，可能是一个保护因素-产前胎儿结合。这项研究的长期目标是开发基于经验的移动健康干预措施，以针对OUD复发的近期风险，当它们实时发生时。中心假设是，在怀孕期间，创伤后应激障碍的症状会随着时间的推移而波动，并将增加或降低近期复发的风险，创伤后应激障碍/复发的关系将由阿片类药物渴望和产前结合的波动调节，并受到特质情绪调节和焦虑敏感性的调节。理由是，与复发相关的因素不是静态的，而是随着时间的推移而波动的。此外，故态复萌的事件在时间上也会发生。我们建议使用生态瞬时评估(EMA：使用移动设备)来收集关于波动的危险因素和阿片类药物每天多次使用的数据，采用基于事件和时间的混合设计，为期6周，以评估孕妇(N=75)OUD复发的近距离危险因素。OUD在妊娠期的复发不同于其他的SUD，因为药物辅助治疗是推荐的护理标准，因此更好地单独检查。在支持设计可行性的强有力的初步数据的指导下，这一假说将通过两个具体的目标进行检验：目的1.研究妊娠期创伤后应激障碍症状和阿片类药物使用之间的近实时联系。目的2.检验妊娠期创伤后应激障碍症状和阿片类药物使用之间的联系的中介因素(产前结合和渴望)和调节因素(焦虑、敏感性和情绪调节)。这项拟议的研究意义重大，因为它有望促进我们对创伤后应激障碍症状、渴求和妊娠特有的保护因素产前结合如何影响复发的理解。最终，这些知识将导致为孕妇量身定做的基于科学的移动健康应用程序。这种方法是创新的，因为它以研究不足的人群为目标，使用以前没有在这方面应用的技术(EMA)，在考虑调节因素的同时，检查最近风险的波动和OUD复发的保护性因素。

This resubmitted application responds to PA-18-602 and seeks to determine on a day-to-day basis how, during pregnancy, posttraumatic stress disorder (PTSD) symptoms are associated with opioid use disorder (OUD) relapse, a fundamental gap in the research. A theoretical framework is developed that identifies prenatal bonding and opioid craving as mediators, and emotion regulation and anxiety sensitivity as moderators, of the central PTSD/relapse relationship. This will be the first study to investigate the temporal ebb and flow of risk and protective factors for OUD relapse for pregnant women and, as such, this study advances the more common situation where research, using fixed assessments, investigates pregnant women with various substance use disorders (SUD). This is an excellent model because pregnant women have unique characteristics that change over time potentially associated with relapse. They have high rates of PTSD (relapse risk factor and common OUD comorbidity), and PTSD cues induce craving that triggers relapses. Importantly, pregnant women have a unique relevant biological variable that may be a protective factor - prenatal fetal bonding. The long term goal of this research is to develop empirically-based mobile-health interventions to target proximal risks for OUD relapse as they occur in real time. The central hypothesis is that during pregnancy PTSD symptoms will fluctuate over time and will increase or reduce proximal risk of relapse, and that the PTSD/relapse relationship will be mediated by fluctuations in opioid craving and prenatal bonding and moderated by trait emotion regulation and anxiety sensitivity. The rationale is that factors associated with relapse are not static, but fluctuate over time. Moreover, relapse events occur at moments in time. We propose to use ecological momentary assessment (EMA: using mobile devices) to collect data on fluctuating risk factors and opioid use multiple times per day using a mixed event and time-based design for 6 weeks, to assess proximal risk factors for OUD relapse in pregnant women (N=75). OUD relapse during pregnancy differs from other SUD, since medication-assisted treatment is the recommended standard of care, and is thus better examined separately. Guided by strong preliminary data supporting design feasibility, this hypothesis will be tested via two specific aims: Aim 1. Examine near real time associations during pregnancy between PTSD symptoms and opioid use. Aim 2. Examine mediators (prenatal bonding and craving) and moderators (anxiety sensitivity and emotion regulation) of associations during pregnancy between PTSD symptoms and opioid use. The proposed research is significant, because it is expected to advance our understanding of how fluctuations in PTSD symptoms, craving, and a pregnancy specific protective factor – prenatal bonding – impact OUD relapse. Ultimately, this knowledge will lead to science-based mobile-health applications tailored for pregnant women. The approach is innovative because it targets an understudied population and examines fluctuation in proximal risk and protective factors for OUD relapse, while accounting for moderators, using a technique (EMA) not previously applied in this context.