IMPORTANCE Mindfulness curricula can improve physician burnout, but implementation during residency presents challenges. OBJECTIVE To examine whether a novel mindfulness curriculum implemented in the first 6 months of internship reduces burnout. DESIGN, SETTING, AND PARTICIPANTS This pragmatic, multicenter, stratified cluster randomized clinical trial of a mindfulness curriculum randomized 340 pediatric interns to the intervention or control arm within program pairs generated based on program size and region. Fifteen US pediatric training programs participated from June 14, 2017, to February 28, 2019. INTERVENTIONS The intervention included 7 hour-long sessions of a monthly mindfulness curriculum (Mindfulness Intervention for New Interns) and a monthly mindfulness refresher implemented during internship. The active control arm included monthly 1-hour social lunches. MAIN OUTCOMES AND MEASURES The primary outcome was emotional exhaustion (EE) as measured by the Maslach Burnout Inventory 9-question EE subscale (range, 7-63; higher scores correspond to greater perceived burnout). Secondary outcomes were depersonalization, personal accomplishment, and burnout. The study assessed mindfulness with the Five Facet Mindfulness Questionnaire and empathy with the Interpersonal Reactivity Index subscales of perspective taking and empathetic concern. Surveys were implemented at baseline, month 6, and month 15. RESULTS Of the 365 interns invited to participate, 340 (93.2%; 255 [75.0%] female; 51 [15.0%] 30 years or older) completed surveys at baseline; 273 (74.8%) also participated at month 6 and 195 (53.4%) at month 15. Participants included 194 (57.1%) in the Mindfulness Intervention for New Interns and 146 (42.9%) in the control arm. Analyses were adjusted for baseline outcome measures. Both arms' EE scores were higher at 6 and 15 months than at baseline, but EE did not significantly differ by arm in multivariable analyses (6 months: 35.4 vs 32.4; adjusted difference, 3.03; 95% CI, -0.14 to 6.21; 15 months: 33.8 vs 32.9; adjusted difference, 1.42; 95% CI, -2.42 to 5.27). None of the 6 secondary outcomes significantly differed by arm at month 6 or month 15. CONCLUSIONS AND RELEVANCE A novel mindfulness curriculum did not significantly affect EE, burnout, empathy, or mindfulness immediately or 9 months after curriculum implementation. These findings diverge from prior nonrandomized studies of mindfulness interventions, emphasizing the importance of rigorous study design and suggesting that additional study is needed to develop evidence-based methods to reduce trainee burnout. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT03148626.

中文翻译：

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新型正念课程对儿科实习期间倦怠的影响：一项整群随机临床试验。

重要性正念课程可以改善医生的倦怠，但在住院期间的实施会带来挑战。目的 检验在实习的前 6 个月实施的新颖正念课程是否能减少职业倦怠。设计、设置和参与者这项实用的、多中心的、分层的正念课程集群随机临床试验将 340 名儿科实习生随机分配到根据项目规模和地区生成的项目对中的干预或控制组。从 2017 年 6 月 14 日到 2019 年 2 月 28 日，参加了 15 个美国儿科培训项目。干预措施包括 7 小时的月度正念课程（新实习生正念干预）和实习期间实施的每月正念复习。主动控制臂包括每月 1 小时的社交午餐。主要结果和测量 主要结果是情绪耗竭 (EE)，由 Maslach 职业倦怠量表 9 问题 EE 子量表测量（范围，7-63；较高的分数对应于更大的感知倦怠）。次要结果是人格解体、个人成就和倦怠。该研究使用五方面正念问卷评估正念，并使用观点采择和同理心关注的人际反应指数子量表评估同理心。调查在基线、第 6 个月和第 15 个月进行。 结果 在受邀参与的 365 名实习生中，340 名（93.2%；255 [75.0%] 女性；51 [15.0%] 30 岁或以上）在基线时完成了调查；273 (74.8%) 人也在第 6 个月参加，195 (53.4%) 人在第 15 个月参加。参与者包括 194 (57. 1% 在新实习生的正念干预中，146 (42.9%) 在控制组。分析针对基线结果测量进行了调整。两组的 EE 评分在 6 个月和 15 个月时均高于基线，但在多变量分析中各组的 EE 没有显着差异（6 个月：35.4 vs 32.4；调整后的差异，3.03；95% CI，-0.14 至 6.21；15个月：33.8 对 32.9；调整后的差异，1.42；95% CI，-2.42 至 5.27）。在第 6 个月或第 15 个月时，6 个次要结果中没有一个在组间有显着差异。结论和相关性一种新颖的正念课程不会立即或在课程实施后 9 个月显着影响 EE、倦怠、同理心或正念。这些发现不同于之前关于正念干预的非随机研究，强调严格的研究设计的重要性，并建议需要进行额外的研究来开发基于证据的方法来减少受训者的倦怠。试验注册 ClinicalTrials.gov 标识符：NCT03148626。