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

创伤后应激障碍的生态瞬时评估和预测孕妇阿片类药物使用障碍复发的产前联系

• 批准号: 9894212
• 负责人: Pilar M Sanjuan
• 金额: $ 23.13万
• 依托单位: UNIVERSITY OF NEW MEXICO
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-03-15 至 2022-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9894212
• 关键词: Accounting; Address; Affect; Alcohol or Other Drugs use; Area; Behavior; Biological; Characteristics; Child; Cues; Data; Data Collection; Development; Drug usage; Ecological momentary assessment; Event; Family; Feeling; Fetal Development; Fetus; Goals; Intervention; Knowledge; Link; Mediating; Mediator of activation protein; Mission; Mobile Health Application; Modeling; National Institute of Drug Abuse; Neonatal Abstinence Syndrome; Opioid; Outpatients; Parents; Population; Post-Traumatic Stress Disorders; Postpartum Depression; Pregnancy; Pregnant Women; Recording of previous events; Relapse; Research; Risk; Risk Factors; Role; Science; Severities; Sex Differences; Substance Use Disorder; Symptoms; Techniques; Testing; Time; Tobacco use; Trauma; United States; United States National Institutes of Health; Woman; alcohol consumption during pregnancy; anxiety sensitivity; associated symptom; base; comorbidity; craving; design; drug craving; drug relapse; emotion regulation; experience; fetal; handheld mobile device; improved; innovation; mHealth; medication-assisted treatment; opioid use; opioid use disorder; opioid use in pregnancy; post-traumatic symptoms; pregnant; prenatal; prenatal health; prenatal risk factor; prevent; protective factors; psychosocial; recruit; relapse risk; standard of care; therapy development; trait

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.

这种重新提交的应用对PA-18-602做出了反应，并寻求每天确定在怀孕期间，创伤后应激障碍（PTSD）症状与阿片类药物使用障碍（OUD）救济（PTSD）症状如何，这是研究中的基本差距。开发了一个理论框架，该框架将产前粘结和阿片类药物渴望视为介体，以及中央PTSD/复发关系的情绪调节和焦虑敏感性。这将是第一项研究孕妇的暂时潮起潮落和风险流动和受保护因素的研究，因此，本研究进展了更常见的情况，在这种情况下，研究使用固定评估调查患有各种药物使用障碍（SUD）的孕妇。这是一个出色的模型，因为孕妇具有独特的特征，随着时间的流逝而变化可能与救济有关。它们具有很高的PTSD（复发风险因素和常见的OUD合并症），而PTSD提示引起了触发继电器的渴望。重要的是，孕妇具有独特的相关生物学变量，可能是保护因素 - 产前胎儿粘结。这项研究的长期目标是开发基于经验的移动医疗干预措施，以实时实现OUD救济的替代风险。中心假设是，在怀孕期间，PTSD症状会随着时间的流逝而波动，并会增加或减少近端缓解风险，并且PTSD/复发关系将通过在阿片类药物的渴望和产前粘结中波动，并通过特质情绪调节和焦虑敏感性来介导。理由是，与缓解相关的因素不是静态的，而是随着时间的流逝而波动。此外，接力赛及时发生。我们建议使用生态瞬时评估（EMA：使用移动设备）来收集有关波动风险因素的数据，并使用基于时间和时间的设计在6周内每天多次使用OID，以评估孕妇的OUD救济率因素（n = 75）。由于药物辅助治疗是推荐的护理标准，因此在怀孕期间与其他SUD差异的释放相差，因此可以更好地检查。在强大的初步数据支持设计可行性的指导下，该假设将通过两个具体目标进行检验：AIM 1。检查PTSD症状和OID使用之间怀孕期间接近实时关联。 AIM 2。检查PTSD症状与OID使用期间怀孕期间的关联过程中的介体（产前粘结和渴望）和主持人（焦虑敏感性和情绪调节）。拟议的研究很重要，因为预计它将提高我们对PTSD症状，渴望和特定特定保护因素的波动（产前粘结）的理解。最终，这些知识将导致针对孕妇量身定制的基于科学的移动健康应用程序。这种方法具有创新性，因为它针对可理解的人群，并且考试在近端风险和保护因素上的波动，同时使用以前在这种情况下未应用的技术（EMA）来考虑主持人。