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

• 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
• 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

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.

孕妇使用大麻的比率正在急剧增加。相当大的一部分 产前使用大麻的妇女表现出临床水平的痛苦（例如，抑郁症和焦虑症），条件 这已经增加了不良结果的风险。事实上，一些妇女可能使用大麻，因为它被认为是 风险更小，或者更容易被接受。 妊娠相关的身体症状（例如，恶心）也被确定为CU的动机。然而，不利的 与围产期CU相关的母亲和儿童的结果已经被记录。尽管医疗 建议避免在怀孕期间使用大麻，目前还没有经过药物测试的有效方法。 采取干预措施，帮助孕妇这样做。我们团队的试验数据以及其他人的发现表明， 许多在产前继续使用CU的妇女对使用它们有矛盾的感觉，并经历挑战 退出的过程。在怀孕时能够退出CU的女性中，复发是 并不罕见，尤其是在分娩后。满足使用大麻的围产期妇女需求的干预措施 妇女-痛苦（抑郁、焦虑）和身体症状（恶心、疼痛）加剧，急需治疗。 身体活动（PA）干预可能发挥关键作用，作为一种替代的应对策略，痛苦的怀孕 女性-从而降低CU。我们的团队在为孕妇开发PA干预措施方面有着悠久的历史。 有成瘾行为的女性和个人。我们是第一个开发和测试生活方式体检的团队 活动（LPA）的方法与抑郁的孕妇，并为妇女与抑郁症的酒精治疗。 LPA干预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涉及短时间的活动 融入日常生活的结构，孕妇可以在从事PA的时刻，以科普 负面影响或渴望作为CU的替代品。鉴于其作为一种有效的、可接受的 可传播的干预措施，以减少围产期CU，我们建议制定一个LPA干预妇女在 产前CU的高风险，并获得有关干预措施的可行性和可接受性的数据。这台R34将拥有 干预开发阶段，包括小型开放性试点试验（N=20），随后是试点 RCT阶段，在此期间，我们将进行一项初步随机试验（N=50），比较LPA+Fitbit条件与 a仅Fitbit条件，在多个点评估CU、PA和其他结果，扩展至4 产后几周在研究结束时，我们将开发和试点测试一种新的技术， 支持对产前CU高危孕妇进行PA干预。如果被认为是可接受和可行的， 这一干预措施的有效性可在随后的充分把握度试验中进行评估。最终，这项研究 将促进妇女制定一种替代应对策略，以管理其痛苦和症状 在怀孕期间，从而减少产前CU和降低风险的不利孕产妇和婴儿的结果。