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

TRANSFER 创伤后应激障碍和产前结合的生态瞬时评估预测孕妇阿片类药物使用障碍复发

• 批准号: 10452007
• 负责人: Pilar M Sanjuan
• 金额: $ 17.12万
• 依托单位: UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR
• 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 2024-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10452007
• 关键词: Accounting; Address; Affect; 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; substance use; 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.

这份重新提交的申请是对PA-18-602的回应，旨在确定在怀孕期间，创伤后应激障碍（PTSD）症状如何与阿片类药物使用障碍（OUD）复发相关，这是研究中的一个根本空白。一个理论框架的发展，确定产前的粘接和阿片类药物的渴求作为调解人，情绪调节和焦虑敏感性作为主持人，中央创伤后应激障碍/复发的关系。这将是第一项研究，以调查的时间潮起潮落的风险和保护因素的OUD复发的孕妇，因此，这项研究的进展更常见的情况下，研究，使用固定的评估，调查孕妇与各种物质使用障碍（SUD）。这是一个很好的模型，因为孕妇有独特的特征，随着时间的推移而改变，可能与复发有关。他们有很高的PTSD（复发风险因素和常见的OUD合并症），PTSD的线索诱导了引发复发的渴望。重要的是，孕妇有一个独特的相关生物变量，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医疗的移动健康干预措施，以针对真实的时间发生的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，并会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结合的波动介导，并由特质情绪调节和焦虑敏感性调节。其基本原理是，与复发有关的因素不是静态的，而是随着时间的推移而波动。此外，复发事件发生在时间的时刻。我们建议使用生态瞬时评估（EMA：使用移动的设备），使用混合事件和基于时间的设计，收集6周内每天多次使用阿片类药物和波动风险因素的数据，以评估孕妇（N=75）OUD复发的近端风险因素。妊娠期间OUD复发与其他SUD不同，因为药物辅助治疗是推荐的护理标准，因此最好单独检查。在支持设计可行性的强有力的初步数据的指导下，将通过两个具体目标对该假设进行检验：目标1。检查怀孕期间PTSD症状和阿片类药物使用之间的真实的时间关联。目标2.检查调解人（产前结合和渴望）和调解人（焦虑敏感性和情绪调节）之间的关联在怀孕期间PTSD症状和阿片类药物的使用。这项拟议中的研究意义重大，因为它有望促进我们对创伤后应激障碍症状、渴望和妊娠特异性保护因素（产前结合）的波动如何影响OUD复发的理解。最终，这些知识将为孕妇量身定制基于科学的移动健康应用程序。该方法是创新的，因为它针对研究不足的人群，并检查波动的近端风险和保护因素的OUD复发，同时占主持人，使用的技术（EMA）以前没有在这种情况下应用。