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：
10463443
负责人：
CYNTHIA L. BATTLE
金额：
$ 23.19万
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/10463443
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 Self Efficacy Structure Substance Use Disorder Symptoms Testing Time Tobacco Treatment Efficacy Walking Woman acceptability and feasibility adverse maternal outcomes adverse outcome alcohol abuse therapy anxiety symptoms base coping cost craving design effective intervention exercise intervention experience fitbit fitness flexibility follow-up high risk improved infant outcome marijuana use marijuana use in pregnancy negative affect new technology pain symptom perinatal cannabis use perinatal period perinatal women physical symptom pilot test pilot trial pregnant prenatal prevent primary outcome programs psychopharmacologic randomized trial safety and feasibility 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.

孕妇吸食大麻的比例（CU）正在急剧增加。产前使用大麻的妇女表现出临床水平的痛苦（例如抑郁、焦虑）、状况事实上，这已经增加了不良结果的风险，一些妇女可能会使用大麻，因为它被认为是一种药物。与抑郁症和焦虑症的精神药物治疗相比，风险更小，或更容易接受。与怀孕相关的身体症状（例如恶心）也被确定为 CU 的动机。尽管有医疗记录，但与围产期 CU 相关的母亲和儿童的结果已有记录。建议在怀孕期间避免使用大麻，目前没有经过实证检验的有效性我们团队的试点数据以及其他人的研究结果表明，帮助孕妇这样做的干预措施。许多在产前继续使用 CU 的女性对其使用有矛盾的感受，并遇到挑战在怀孕后能够戒烟的女性中，复发率很高。并不少见，特别是在分娩后解决使用大麻的围产期需求的干预措施。女性——迫切需要缓解痛苦（抑郁、焦虑）和身体症状（恶心、疼痛）。体力活动 (PA) 干预措施可能作为痛苦孕妇的替代应对策略发挥关键作用女性 – 从而减少 CU 我们的团队在开发孕妇 PA 干预措施方面拥有丰富的历史。我们是第一批开发和测试生活方式身体的人。活动（LPA）方法治疗抑郁症孕妇，以及针对抑郁症妇女的酒精治疗。 LPA 干预措施是简单的低成本方法，由简短的咨询和活动支持监视器（例如 Fitbit）以促进目标设定和监控，因为 LPA 涉及短暂的活动。融入日常生活结构，孕妇可以即时进行PA来应对鉴于其作为一种有效、可接受和可靠的潜力，可以将其作为 CU 的替代品。为了减少围产期 CU，我们建议为妇女制定 LPA 干预措施产前 CU 的高风险，并获得有关干预措施可行性和可接受性的数据。干预开发阶段，其中包括小型开放试点试验（N = 20），然后是试点 RCT 阶段，在此期间我们将进行一项试点随机试验 (N=50)，将 LPA+Fitbit 条件与仅 Fitbit 条件，对 CU、PA 和其他结果的多个点的评估扩展到 4 在研究结束后几周，我们将开发并试点测试一种新颖的技术—— 支持对产前 CU 高风险孕妇进行 PA 干预如果认为可以接受且可行，最终，这项研究可以在后续的全功率试验中评估这种干预的效果。将有助于制定女性的替代应对策略来管理她们的痛苦和症状怀孕期间，从而减少产前 CU 并降低母婴不良结局的风险。