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.

孕妇的大麻使用率(CU)正在急剧增加。相当大比例的 使用大麻的妇女在产前表现出临床水平的痛苦(例如，抑郁和焦虑)、条件 这已经增加了糟糕结果的风险。事实上，一些女性可能会使用大麻，因为它被认为是 与抑郁症和焦虑症的精神药物治疗相比，风险更低，或更容易接受。 与怀孕有关的身体症状(如恶心)也被认为是CU的动机。然而，不利的是 与围产期CU相关的母亲和儿童的结局都已被记录在案。尽管医学上 建议避免在怀孕期间使用大麻，目前还没有经验证明有效 帮助孕妇这样做的干预措施。我们团队的试点数据以及其他人的发现表明， 许多继续产前接受CU的女性对CU的使用有矛盾的感觉，并经历了挑战 在戒烟的过程中。在怀孕后能够退出CU的女性中，复发是 并不少见，尤其是在分娩之后。应对围产期吸食大麻需求的干预措施 妇女--极度需要增加痛苦(抑郁、焦虑)和身体症状(恶心、疼痛)。 体力活动(PA)干预可能作为应对窘迫妊娠的替代策略发挥关键作用 女性--因此降低了CU。我们的团队在为怀孕开发PA干预方面有很强的历史 有上瘾行为的妇女和个人。我们是第一批开发和测试生活方式体格的人 活动(LPA)方法适用于抑郁症孕妇，并适用于抑郁症妇女的酒精治疗。 LPA干预代表了简单、低成本的方法，得到了短暂的咨询和活动的支持 监控器(例如Fitbit)，以促进目标设定和监控。因为LPA包括短时间的活动 融入日常生活结构，孕妇可在瞬间搞PA应对 消极的情绪或渴望作为CU的替代品。鉴于其作为有效的、可接受的和 为减少围产期CU，我们建议为妇女制定一项LPA干预措施 产前CU的高风险，并获得关于干预的可行性和可接受性的数据。这款R34将拥有 干预发展阶段，将包括一项小型开放试点试验(N=20)，然后是一项试点 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 仅限Fitbit的情况，CU、PA和其他结果在多个点的评估延伸到4 产后几周。在研究结束时，我们将开发并试点测试一种新型技术-- 支持PA对产前CU高危孕妇的干预。如果认为可以接受和可行， 这种干预的效果可以在随后的全功率试验中进行评估。最终，这项研究 将促进为妇女制定另一种应对策略，以管理她们的痛苦和症状 在怀孕期间，从而减少产前CU，降低不良母婴结局的风险。