Development of a lifestyle physical activity intervention to reduce risk for perinatal cannabis use

制定生活方式体育活动干预措施以降低围产期大麻使用风险

基本信息

批准号：
10584540
负责人：
CYNTHIA L. BATTLE
金额：
$ 22.08万
依托单位：
BUTLER HOSPITAL (PROVIDENCE, RI)
依托单位国家：
美国
项目类别：
财政年份：
2022
资助国家：
美国
起止时间：
2022-04-01 至 2025-02-28
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10584540
关键词：
Abstinence Addictive Behavior Address Alcohol consumption Anxiety Birth Cannabis Child Clinical Coping Skills Counseling Data Depressed mood Development Distress Dropout Drug usage Educational Intervention Effectiveness Emotional Exhibits Feeling Future Goals Health Status High Risk Woman Household Individual Intervention Interview Lactation Life Life Style Light Low Birth Weight Infant Manuals Mediating Medical Mental Depression Monitor Moods Mothers Nausea Outcome Pain Participant Patient Self-Report Phase Physical activity Play Postpartum Period Pregnancy Pregnant Women Premature Birth Process Program Acceptability Psyche structure Public Health Recommendation Recording of previous events Relapse Research Risk Risk Reduction Safety Self Efficacy Structure Substance Use Disorder Symptoms Technology Testing Time Tobacco Treatment Efficacy Walking Woman acceptability and feasibility adverse maternal outcomes adverse outcome alcohol abuse therapy anxiety symptoms coping cost craving depressive symptoms design effective intervention exercise intervention experience fitbit fitness flexibility follow-up high risk improved infant outcome marijuana use marijuana use in pregnancy negative affect novel perinatal cannabis use perinatal period perinatal women physical symptom pilot test pilot trial pregnant prenatal prevent primary outcome programs psychopharmacologic randomized trial secondary outcome substance use therapy development vigorous intensity

项目摘要

Rates of cannabis use (CU) among pregnant women are increasing dramatically. A sizable proportion of women who use cannabis prenatally exhibit clinical levels of distress (e.g., depression and anxiety), conditions that already raise risk for poor outcomes. Indeed, some women may use cannabis because it is perceived as less risky, or more acceptable, than psychopharmacological treatments for depression and anxiety. Pregnancy-related physical symptoms (e.g., nausea) are also identified motives for CU. However, adverse outcomes to both mother and child associated with perinatal CU have been documented. Despite medical recommendations to avoid cannabis use during pregnancy, there are currently no empirically-tested effective interventions to aid pregnant women in doing so. Our team’s pilot data, as well as others’ findings, show that many women who continue CU prenatally have conflicted feelings about their use, and experience challenges with the process of quitting. Among women who are able to quit CU when they become pregnant, relapse is not uncommon, especially after delivery. Interventions that address the needs of cannabis-using perinatal women - elevated distress (depression, anxiety) and physical symptoms (nausea, pain) are critically needed. Physical activity (PA) interventions may play a key role as an alternate coping strategy for distressed pregnant women – thus decreasing CU. Our team has a strong history of developing PA interventions for pregnant women and individuals with addictive behaviors. We were the first group to develop and test a lifestyle physical activity (LPA) approach with depressed pregnant women, and for women with depression in alcohol treatment. LPA interventions represent simple low-cost approaches that are supported by brief counseling and activity monitors (e.g., Fitbit) to facilitate goal-setting and monitoring. Because LPA involves short bouts of activity integrated into the structure of daily life, pregnant women can engage in PA in-the-moment to cope with negative affect or cravings as an alternate to CU. In light of its potential as an efficacious, acceptable, and disseminable intervention to reduce perinatal CU, we propose to develop an LPA intervention for women at high risk for prenatal CU, and obtain data on the intervention’s feasibility and acceptability. This R34 will have an intervention development phase, which will include a small open pilot trial (N=20), followed by a pilot RCT phase, during which we will conduct a pilot randomized trial (N=50) comparing the LPA+Fitbit condition to a Fitbit Only condition, with assessments of CU, PA, and other outcomes at multiple points extending to 4 weeks postpartum. At the study’s conclusion, we will have developed and pilot-tested a novel, technology- supported PA intervention for pregnant women at high risk for prenatal CU. If deemed acceptable and feasible, the efficacy of this intervention can be evaluated in a subsequent fully-powered trial. Ultimately, this research will facilitate development of an alternate coping strategy for women to manage their distress and symptoms during pregnancy, thus decreasing prenatal CU and lowering risk for adverse maternal and infant outcomes.

孕妇的大麻使用率（CU）急剧增加。相当一部分使用大麻产前暴露的临床苦难水平（例如抑郁和动画）的妇女这已经增加了不良结果的风险。确实，有些女性可能会使用大麻，因为它被认为是与抑郁症和动画的心理药物治疗相比，风险较小，或更容易接受。与妊娠有关的身体症状（例如恶心）也是CU的动机。但是，逆境已经记录了与围产期铜有关的母子和儿童的结果。尽管有医疗建议避免怀孕期间使用大麻的建议，目前尚无经验测试的有效性干预措施以帮助孕妇这样做。我们团队的飞行员数据以及其他人的发现表明许多继续产前CU的女性对自己的使用有着矛盾的感觉，并经历了挑战随着退出的过程。在怀孕时能够退出Cu的女性中，退休是并不少见，尤其是在交货之后。解决大麻围产期需求的干预措施妇女 - 迫切需要苦难（抑郁，动画）和身体症状（恶心，疼痛）。体育锻炼（PA）干预措施可能会作为困扰怀孕的替代应对策略发挥关键作用妇女 - 从而减少Cu。我们的团队有悠久的历史来为怀孕开发PA干预措施具有加性行为的妇女和个人。我们是第一个发展和测试生活方式的小组活动（LPA）与抑郁症的妇女以及酒精治疗中抑郁症的妇女接近。 LPA干预措施代表简单的低成本方法，这些方法得到了简短的咨询和活动的支持监视（例如Fitbit），以促进目标设定和监视。因为LPA涉及短暂的活动孕妇可以融入日常生活的结构中负面影响或渴望作为CU的替代品。鉴于它具有有效，可接受的潜力我们提出的可融合干预措施以减少围产期CU，我们建议为妇女开发LPA干预措施产前CU的高风险，并获取有关干预措施的可行性和可接受性的数据。这个R34将有干预开发阶段，其中将包括一项小型开放试验试验（n = 20），然后是飞行员 RCT阶段，在此期间，我们将进行一项试验（n = 50），将LPA+FITBIT条件与仅FITBIT条件，对CU，PA和其他结果进行评估，以延伸到4 产后周。在研究的结论中，我们将开发并试点测试了一种新颖的技术 - 支持对产前CU风险高风险的孕妇的PA干预。如果认为可以接受和可行，可以在随后全力以赴的试验中评估这种干预措施的效率。最终，这项研究将促进制定妇女管理痛苦和症状的替代应对策略在怀孕期间，从而降低了产前CU并降低了不良母乳和婴儿预后的风险。