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.

此重新提交的申请是对 PA-18-602 的回应，旨在每天确定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，这是阿片类药物使用障碍 (OUD) 复发的一个根本差距。研究建立了一个理论框架，将产前联结和阿片类药物的渴望作为调节因素，将情绪调节和焦虑敏感性作为中心创伤后应激障碍/复发关系的调节因素。孕妇 OUD 复发的保护因素，因此，这项研究提出了更常见的情况，即研究使用固定评估来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，因为孕妇具有独特的特征。随着时间的推移，这些变化可能与复发有关。她们有很高的 PTSD（复发风险因素和常见 OUD 合并症）发生率，而 PTSD 线索会诱发引发复发的渴望，重要的是，孕妇有一个独特的相关生物变量，这可能是一个保护因素。 - 这项研究的长期目标是开发基于移动健康的干预措施，以针对实时发生的 OUD 复发的近端风险。中心假设是，在怀孕期间 PTSD 症状会随着时间的推移而波动。增加或减少复发的近端风险，并且 PTSD/复发关系将由阿片类药物渴望和产前联系的波动介导，并受到特质情绪调节和焦虑敏感性的调节。其基本原理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。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和每天多次阿片类药物使用的数据。为期 6 周的基于事件和时间的设计，用于评估孕妇 OUD 复发的近端危险因素（N = 75），与其他 SUD 不同，因为药物辅助治疗是推荐的护理标准，并且是因此，在支持设计可行性的有力初步数据的指导下，该假设将通过两个具体目标进行检验： 目标 1. 检查妊娠期间 PTSD 症状与阿片类药物使用之间的近实时关联 目标 2. 检查中介因素（产前联系和阿片类药物使用）。妊娠期间 PTSD 症状与阿片类药物使用之间关联的调节因素（焦虑敏感性和情绪调节）这项研究意义重大，因为它有望增进我们对 PTSD 症状、渴望和妊娠特异性保护作用如何波动的理解。最终，这些知识将带来为孕妇量身定制的基于科学的移动健康应用程序，因为它针对的是未充分研究的人群，并检查了 OUD 复发的近端风险和保护因素的波动。 ，在考虑主持人的同时，使用了以前未在此背景下应用的技术（EMA）。