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JAMA Network logoLink to JAMA Network
. 2022 Jan 24;176(4):365–372. doi: 10.1001/jamapediatrics.2021.5740

Effect of a Novel Mindfulness Curriculum on Burnout During Pediatric Internship

A Cluster Randomized Clinical Trial

Yarden S Fraiman 1,2,3,, Christine C Cheston 4, Howard J Cabral 5, Celeste Allen 6, Andrea G Asnes 7, Jefferson T Barrett 8,9,10, Maneesh Batra 11, William Bernstein 12, Tammy Bleeker 13, Pam M Dietz 14, Joanna Lewis 15, Su-Ting T Li 16, T Marsha Ma 17, John D Mahan 18, Catherine D Michelson 4, Sue E Poynter 19, Mark A Vining 20, Katherine Watson 21, Colin M Sox 4
PMCID: PMC8787682  PMID: 35072694

Key Points

Question

Can a novel mindfulness curriculum designed for implementation in residency that does not require facilitator training reduce burnout among pediatric interns?

Findings

This cluster randomized clinical trial found that the levels of emotional exhaustion, depersonalization, burnout, empathy, and mindfulness among pediatric interns who completed the 6-month mindfulness curriculum did not significantly differ from those assigned to social lunches both immediately after completing the training experience and 9 months later.

Meaning

A novel mindfulness curriculum did not affect pediatric interns’ levels of burnout, empathy, and mindfulness compared with social time only, suggesting that additional study is needed to develop evidence-based methods to reduce trainee burnout.

Abstract

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


This cluster randomized clinical trial of pediatric interns assesses whether a novel mindfulness training program reduces burnout.

Introduction

Burnout is a triad of emotional exhaustion (EE), depersonalization, and feelings of inefficacy.1 Between 39% and 75% of pediatric trainees experience burnout, with a worsening trend in prevalence during the past few decades.2,3,4,5 Burnout affects physicians’ well-being, performance during training, risk of suicide, and patient care. Physicians with burnout are more likely to make medical errors and be less empathetic, and the patients of physicians with burnout are less likely to adhere to medical plans.6,7,8,9,10,11 Physician burnout costs the US health care system approximately $4.6 billion per year related to physician turnover and reduced productivity.12

Mindfulness, a state of nonjudgmental awareness in the present moment, can prevent burnout. Mindfulness curricula can reduce burnout among physicians and other professionals.13,14,15,16,17,18 Mindfulness is the only evidence-based approach to reduce burnout included in an Accreditation Council for Graduate Medical Education and American Academy of Pediatrics call for systems-level change to address trainee burnout.19 Although mindfulness curricula are effective, potential barriers to implementing mindfulness curricula include time required by the trainees and availability of facilitators with content expertise. Small single-center trials17,18,20,21 of mindfulness have found variable effects. We know of no published multicenter randomized clinical trials of mindfulness curricula that target trainee burnout. To assess the effectiveness of a novel mindfulness curriculum that does not require prior facilitator training, Mindfulness Intervention for New Interns (MINdI),22 on burnout among pediatric interns, we conducted a multicenter cluster randomized clinical trial. We hypothesized that interns training in programs randomized to the mindfulness curriculum would have less burnout than interns randomized to the control arm.

Methods

Study Sample and Randomization

We conducted a pragmatic, multicenter, stratified cluster randomized clinical trial of a mindfulness curriculum during pediatric internship. See Supplement 1 for full trial protocol. We recruited 15 US pediatric residency programs to participate in this study and sent surveys to 365 eligible interns (Figure 1). All sites’ institutional review boards approved the study. To be eligible for inclusion, each participating pediatric residency program agreed to be randomized to have their interns experience the MINdI curriculum or social lunches. From June 14 to September 29, 2017, pediatric and medicine-pediatric interns training in study programs gave implied written consent by returning the baseline survey. All data were deidentified. This study followed the Consolidated Standards of Reporting Trials (CONSORT) reporting guideline.

Figure 1. CONSORT Study Flow Diagram.

Figure 1.

MINdI indicates Mindfulness Intervention for New Interns.

After pairing programs by location and size, we used a random-number generator to assign, within a pair, each program’s cluster of interns to experience a novel 7-session MINdI curriculum or an active control experience of nondidactic social lunch. Because an odd number of programs participated, we created 1 dummy variable for paired randomization. Each program’s interns had the same arm-specific unblinded training experience.

Intervention Arm

A 6-step approach to curricular design informed the development of MINdI.22,23 The MINdI curriculum easily integrates into existing 1-hour didactic time ubiquitous among training programs and requires no additional facilitator training.22 Intervention programs received the MINdI facilitator manual and all necessary curriculum implementation supplies. The intervention was delivered monthly, starting during the first quarter of the intern year and continuing for 6 months, for a total of 7 sessions; programs were encouraged to facilitate interns’ attendance at MINdI sessions, although attendance was not required.

The MINdI curriculum was developed by a multidisciplinary team of medical education experts, residency program leadership, a chief resident, mindfulness practitioners, and trainees. Briefly, each session begins with a social lunch, followed by a minute of silence, introductory remarks regarding the mindfulness exercise, a mindfulness exercise, and a debriefing period. The curriculum is designed to provide mindfulness exercises that can easily be integrated into a medical trainee’s day or highlight a unique aspect of mindfulness that can be beneficial to medical trainees. In addition to the monthly curriculum, intervention programs were encouraged to invite participants to conduct a short mindfulness refresher, a 10-minute prerecorded body scan exercise, 2 weeks after each MINdI session.

Control Arm

In the active control arm, participants were scheduled to attend 6 interns-only, 1-hour social lunches that involved no mindfulness activities, as other mindfulness curricula randomized clinical trials have done.18

Outcomes

Outcomes were measured through surveys at baseline, month 6, and month 15. The Maslach Burnout Inventory Human Services Survey was used under license with Mind Garden Inc. The primary outcome (EE) was measured using the Maslach Burnout Inventory 9-question EE subscale (range, 7-63; higher scores correspond to higher degrees of perceived burnout).1 Prespecified secondary outcomes included dichotomized burnout and the Maslach Burnout Inventory 5-item depersonalization subscale (range, 7-35; higher scores correspond to higher degrees of perceived burnout) and 8-item personal accomplishment subscale (range, 7-56; higher scores correspond to lower degrees of perceived burnout), as well as mindfulness and empathy. We defined burnout as having an EE score of 27 or higher and/or a depersonalization score of 10 or higher.1,24 We measured mindfulness using the 39-item Five Facet Mindfulness Questionnaire, on which higher scores on a scale of 39 to 195 are interpreted as increased mindfulness.25,26 We assessed empathy using the Interpersonal Reactivity Index’s Perspective Taking and Empathic Concern subscales, on which higher scores are interpreted as increased empathy.27,28

The baseline survey also collected demographic information and report of prior mindfulness behaviors; surveys at months 6 and 15 also collected self-report of mindfulness-related knowledge, attitudes, and behaviors. Surveys at baseline were implemented before participants completed the first study session, and those at month 6 were implemented after completing the final study session. Participants were offered a $5 coffee gift card after completing each survey.

Statistical Analysis

To examine whether subject characteristics varied by study arm while addressing hierarchical effects of cluster randomization, we conducted bivariate linear generalized estimating equations and logistic regressions clustered on center. To estimate the between-group difference in outcome between the randomized groups while addressing hierarchical effects of cluster randomization, we used multivariate generalized estimating equations and logistic regressions clustered on center. All regressions included study arm, independent measures that significantly differed by study arm, or measures that were of a priori clinical interest, including self-identified gender and age. Race and ethnicity data were not collected because we did not consider race or ethnicity to be significantly associated with burnout during the study design. To address the concern of including independent variables possibly in the causal pathway, we performed additional sensitivity analyses without these variables and that included only baseline variables.

In addition, analyses of data at month 6 and/or month 15 controlled for the outcome at baseline, baseline survey month, prior weekend off at month 6, inpatient or intensive care rotation at month 15, and an arm × survey period interaction term based on prior data.29 If the arm × survey month interaction term was statistically significant, we conducted stratified analyses of the month 6 and month 15 data. If the interaction term was not significant, then we removed the interaction term and conducted longitudinal analyses comparing the pooled outcomes at month 6 and month 15 while controlling for baseline.

Because 29.8% of data was missing, we conducted all multivariable analyses on 20 imputed data sets created using individual-level data following standard imputation procedures using PROC MI and PROC MI ANALYZE in SAS software, version 9.4 (SAS Institute Inc). These imputations were performed in PROC MI via a multiple imputation with chained equations approach with fully conditional specification. Data were imputed when missing at baseline given variables with fully observed values. Then the baseline data and fully observed variables at 6 months were used to impute values for variables with missing data at 6 months. This process continued in a similar fashion, with prior data and variables fully observed at 15 months used to impute missing values at 15 months. We report effect sizes as linear regression coefficients quantifying differences in means or in logistic model odds ratios (ORs) with 95% CIs, as well as 2-sided P values for primary outcome analyses. A 2-sided P < .05 was considered statistically significant.

Setting 1 − β = 0.8 and 2-sided α = .05, our a priori power calculations determined that at least 139 participants per group were needed to determine a 0.29 difference in mean EE to be statistically significant, a threshold selected because a meta-analysis30 found that burnout reduction interventions significantly lowered EE scores by 0.28. These calculations, however, did not account for possible clustering by site. Had this been done, applying a reasonable intraclass correlation of 0.01 would have yielded a required enrollment sample with an additional 256 participants to achieve 80% power with a 2-sided α = .05. This addition of participants to the sample would not have been feasible, however, given the planned study period. We note that our sample as implemented was larger than other randomized clinical trials of mindfulness curricula that have intended to address burnout. We have provided 95% CIs with all estimates of group differences so that readers can judge the precision, or lack thereof, of our findings in this sample, in particular with respect to prior research14,15,16,17 with smaller samples.

Results

Study Participants

Of the 359 consenting interns, 340 (94.7%; 255 [75.0%] female; 51 [15.0%] 30 years or older) completed surveys at baseline, 273 at month 6 (76.0%), and 195 at month 15 (54.3%); the 19 interns who did not complete the baseline survey were excluded. Analyses included 194 intervention participants (57.1%) and 146 control participants (42.9%). The dropout rate was 19.7% at 6 months and 42.6% at 15 months. Characteristics between those who were lost to follow-up and those who completed the study were not markedly different (eTable in Supplement 2).

Table 1 presents the study population characteristics. Gender was the only personal or program characteristic that significantly differed by arm, with more female interns in the MINdI arm than in the control arm (female vs male: 255 [75.0%] vs 85 [25.0%] for all interns; 153 [78.9%] vs 41 [21.1%] for MINdI arm; and 102 [69.9%] vs 44 [30.1%] for the control arm; P = .002). The only outcome that significantly differed at baseline in bivariate analyses was personal accomplishment, with the MINdI arm’s mean (SD) personal accomplishment score being higher than that in the control group (41.5 [4.1] vs 36.3 [10.9]; P = .003). Although burnout and mean EE and depersonalization scores did not differ at baseline by arm, these measures significantly increased during the 78-day enrollment period for 4 months in both groups (Figure 2). At month 6, MINdI participants were significantly less likely to have had the prior weekend off than controls (54 [39.4%] vs 54 [46.6%]; P = .04). At month 15, MINdI participants were significantly less likely to be rotating on an inpatient or intensive care service than controls (44 [43.1%] vs 48 [58.5%]; P = .02). Table 2 and Table 3 present results of multivariable analyses of 20 imputed data sets conducted to determine the effect of arm on continuous and dichotomous outcomes, respectively.

Table 1. Study Sample Characteristics and Outcome at Baselinea.

Characteristic or outcome All (N = 340) MINdI arm (n = 194) Control arm (n = 146)
Personal characteristics
Gender
Female 255 (75.0) 153 (78.9) 102 (69.9)
Male 85 (25.0) 41 (21.1) 44 (30.1)
Age ≥30 y 51 (15.0) 32 (16.6) 19 (13.0)
No prior mindfulness training 103 (30.5) 61 (31.6) 42 (29.0)
No prior mindfulness practice 56 (16.5) 30 (15.5) 26 (17.8)
Program characteristics
Program with <20 interns 93 (27.4) 48 (24.7) 45 (30.8)
US region
Eastern 159 (44.3) 66 (34.0) 91 (62.3)
Central 118 (32.9) 59 (30.4) 42 (27.8)
Western 82 (22.8) 69 (35.6) 13 (8.9)
Medicine-pediatrics residents 16 (4.7) 11 (5.7) 5 (3.5)
Survey implementation
Baseline (survey during intern orientation) 213 (62.7) 118 (60.8) 95 (65.1)
Month 6
Vacation in prior month 77 (30.4) 43 (31.4) 34 (29.3)
Prior weekend off 108 (42.7) 54 (39.4) 54 (46.6)
Rotating on inpatient or intensive care service 184 (73.0) 104 (76.5) 80 (69.0)
Month 15
Vacation in prior month 61 (32.8) 29 (28.2) 32 (38.6)
Prior weekend off 98 (52.7) 58 (56.3) 40 (48.2)
Rotating on inpatient or intensive care service 92 (50.0) 44 (43.1) 48 (58.5)
Outcomes at baselineb
Burnout 233 (68.5) 145 (74.7) 88 (60.3)
Emotional exhaustion, mean (SD)c 27.2 (9.7) 28.2 (10.1) 25.9 (8.9)
Depersonalization, mean (SD)d 11.5 (5.1) 11.9 (5.0) 11.0 (4.8)
Personal accomplishment, mean (SD)e 39.3 (8.2) 41.5 (4.1) 36.3 (10.9)
Empathetic concerns, mean (SD)f 17.9 (2.2) 18.0 (2.0) 17.9 (2.2)
Perspective taking, mean (SD)f 19.3 (2.9) 19.4 (3.0) 19.2 (2.8)
Mindfulness, mean (SD)g 127.7 (16.3) 126.7 (16.5) 126.7 (16.1)

Abbreviation: MINdI, Mindfulness Intervention for New Interns.

a

Data are presented as number (percentage) of interns unless otherwise indicated.

b

On the basis of analyses of nonimputed responses from study participants measured at baseline.

c

Total scores on the 9-item emotional exhaustion subscale (range, 7-63; higher scores correspond to higher degrees of perceived burnout).

d

Total scores on the 5-item depersonalization subscale (range, 7-35; higher scores correspond to higher degrees of perceived burnout).

e

Total scores on the 8-item personal accomplishment subscale (range, 7-56; higher scores correspond to lower degrees of perceived burnout).

f

Total scores on the 7-item perspective taking subscale (range, 7-35; higher scores correspond to higher degrees of perceived empathy).

g

Total scores on the 39-item Five Facet Mindfulness scale (range, 39-195; higher scores correspond to higher degrees of perceived mindfulness).

Figure 2. Burnout at Baseline Measurement.

Figure 2.

MINdI indicates Mindfulness Intervention for New Interns.

Table 2. Impact of the MINdI Curriculum on Continuous Measures of Burnout, Mindfulness, and Empathy at Baseline, Month 6, and Month 15a.

Outcomes Baseline, unadjusted mean Month 6 Month 15 Pooled MINdI vs control
Unadjusted mean Adjusted difference (95% CI)b Unadjusted mean Adjusted difference (95% CI)c Unadjusted mean Adjusted difference (95% CI)d
Emotional exhaustion
MINdI arm 28.3 35.4 3.03 (−0.14 to 6.21) 33.8 1.42 (−2.42 to 5.27) NA NA
Control arm 25.6 32.4 32.9 NA NA
Depersonalization
MINdI arm 11.9 16.0 1.2 (−0.56 to 2.96) 15.0 −0.27 (−2.37 to 1.83) NA NA
Control arm 11.0 14.8 15.5 NA NA
Personal accomplishment
MINdI arm 41.5 41.6 0.06 (−1.80 to 7.91) NA NA 40.5 0.14 (−1.70 to 1.98)
Control arm 36.3 41.6 NA NA 39.5
Mindfulness
MINdI arm 126.6 125.5 −0.91 (−5.67 to 3.85) NA NA 128.6 −1.07 (−5.27 to 3.13)
Control arm 126.5 126.4 NA NA 127.1
Empathetic concerns
MINdI arm 18.0 17.2 0.24 (−0.71 to 1.18) NA NA 16.7 0.27 (−0.54 to 1.08)
Control arm 17.9 17.0 NA NA 17.0
Perspective taking
MINdI arm 19.4 21.5 1.02 (−0.36 to 2.41) NA NA 20.7 0.74 (−0.53 to 2.02)
Control arm 19.2 20.4 NA NA 20.8

Abbreviations: MINdI, Mindfulness Intervention for New Interns; NA, not applicable (pooled analyses were not completed based on the interaction term).

a

Mean results are from multivariable analyses of 20 imputed data sets.

b

Results of multivariable generalized estimating equation regressions at month 6 clustered on site while controlling for gender, age, month at baseline, baseline personal accomplishment, prior weekend off, and the outcome of interest at baseline.

c

Results of multivariable generalized estimating equation regressions at month 15 clustered on site while controlling for gender, age, month at baseline, baseline personal accomplishment, current inpatient rotation, and the level of the outcome at month 6. The longitudinal data were stratified by assessment period (month 6 and month 15) because preliminary models that included a MINdI arm × period interaction term were statistically significant.

d

Results of multivariable longitudinal generalized estimating equation regressions comparing pooled month 6 and month 15 while controlling for gender, age, month at baseline, baseline personal accomplishment, current inpatient rotation, and the outcome at baseline.

Table 3. Impact of the MINdI Curriculum on Dichotomous Measure of Burnout and Mindfulness-Related Knowledge, Behavior, and Attitudes at Baseline, Month 6, and Month 15a.

Outcomes Baseline, unadjusted rate Month 6 Month 15 Pooled MINdI vs control
Unadjusted rate, % AOR (95% CI)b Unadjusted rate, % AOR (95% CI)c Unadjusted rate, % AOR (95% CI)d
Burnout e
MINdI arm 74.7 92.0 2.28 (0.77-6.71) 83.7 0.60 (0.17-2.20) NA NA
Control arm 60.3 80.5 88.3 NA NA
Knows evidence supporting mindfulness
MINdI arm NA 69.4 3.23 (1.63-6.39) NA NA 68.3 2.56 (1.46-4.47)
Control arm NA 40.4 NA NA 58.1
Knows how to apply mindfulness in own life
MINdI arm NA 76.9 3.99 (3.25-4.90) 80.4 1.64 (0.66-4.10) NA NA
Control arm NA 42.5 71.0 NA NA
Believes mindfulness benefited their life
MINdI arm NA 60.1 2.51 (1.03-6.11) 73.0 1.24 (0.44-3.49) NA NA
Control arm NA 27.0 63.2 NA NA
Holds positive attitude toward mindfulness
MINdI arm NA 72.2 2.60 (1.67-4.07) 64.1 0.64 (0.24-1.74) NA NA
Control arm NA 56.5 67.8 NA NA
Uses mindfulness techniques more often
MINdI arm NA 38.9 1.48 (0.72-3.02) NA NA 64.7 1.02 (0.57-1.82)
Control arm NA 25.9 NA NA 61.9

Abbreviations: AOR, adjusted odds ratio; MINdI, Mindfulness Intervention for New Interns; NA, not applicable (pooled analyses were not completed based on the interaction term).

a

Mean results are from multivariable analyses of 20 imputed data sets.

b

Results of multivariable logistic regressions at month 6 clustered on site while controlling for gender, age, month at baseline, baseline personal accomplishment, prior weekend off, current inpatient rotation, and the outcome of interest at baseline.

c

Results of multivariable logistic regressions at month 15 clustered on site while controlling for gender, age, month at baseline, baseline personal accomplishment, prior weekend off, current inpatient rotation, and the level of the outcome at month 6. The longitudinal data were stratified by assessment period (month 6 and month 15) because preliminary models that included a MINdI arm × period interaction term were statistically significant.

d

Results of multivariable longitudinal logistic regressions comparing month 6 to month 15 while controlling for gender, age, month at baseline, baseline personal accomplishment, prior weekend off, current inpatient rotation, the outcome at baseline, assessment period, and a MINdI arm × period interaction term.

e

Because initial logistic regressions models analyzing burnout at month 6 that clustered on site did not converge, the final regression model for burnout at month 6 did not cluster on site.

Primary Outcomes

In multivariable analyses of imputed data, EE at baseline did not significantly differ between the MINdI and control arms (adjusted difference, −0.37; 95% CI, −3.03 to 3.77) (Table 2). The MINdI and control arms’ mean (SD) EE scores were higher at month 6 (35.4 vs 32.4) than baseline (28.3 vs 25.6); however, multivariable analyses controlling for baseline EE revealed that EE at month 6 did not significantly differ by study arm (adjusted difference, 3.03; 95% CI, −0.14 to 6.21). Both arms’ mean EE scores remained higher than baseline at month 15 (33.8 vs 32.9). In multivariable longitudinal analyses, the arm-period interaction term was statistically significant (P = .02); in stratified multivariable analyses, EE did not significantly differ by arm at month 15 (adjusted difference, 1.42; 95% CI, −2.42 to 5.27).

Secondary Outcomes

Most respondents had burnout at baseline (74.7% in the MINdI arm and 60.3% in the control arm, month 6 (92.0% in the MINdI arm and 80.5% in the control arm), and month 15 (83.7% in the MINdI arm and 88.3% in the control arm) (Table 3). At baseline, no differences by arm were found in burnout, depersonalization (mean [SD] scores, 11.9 [5.0] for the MINdI arm and 11.0 [4.8] for the control arm), mindfulness (mean [SD] scores, 126.6 [16.4] for the MINdI arm and 126.5 [16.1] for the control arm), empathetic concerns (mean [SD] scores, 18.0 [2.0] for the MINdI arm and 17.9 [2.2] for the control arm), or perspective taking (mean [SD] scores 19.4 [3.0] for the MINdI arm and 19.2 [2.8] for the control arm).

No significant differences by arm were found in prior mindfulness training (31.6% in the MINdI arm and 29.0% in the control arm) or practice (15.5% in the MINdI arm and 17.8% in the control arm) at baseline. Multivariable longitudinal analyses revealed that levels of mindfulness (adjusted difference, −1.07; 95% CI, −5.27 to 3.13), empathetic concerns (adjusted difference, 0.27; 95% CI, −0.54 to 1.08), perspective taking (adjusted difference, 0.74; 95% CI, −0.53 to 2.02), and personal accomplishment (adjusted difference, 0.14; 95% CI, −1.70 to 1.98) did not significantly differ by arm between month 6 and month 15. The arm × period interaction term was statistically significant in multivariable longitudinal analyses conducted to the effect of arm on depersonalization (P < .001) and burnout (P = .004); subsequent multivariable analyses stratified by period revealed that these outcomes did not significantly differ by arm at month 15.

At month 6, multivariable analyses identified significant increases in report of knowing the evidence to support mindfulness (adjusted OR, 3.23; 95% CI, 1.63-6.39), how to apply mindfulness (adjusted OR, 3.99; 95% CI, 3.25-4.90), the belief that mindfulness benefited their life (adjusted OR, 2.51; 95% CI, 1.03-6.11), and having a positive attitude toward mindfulness (adjusted OR, 2.60; 95% CI, 1.67-4.07). Most of these changes were not persistent over time. Self-reported frequency of mindfulness practice at baseline and month 6 did not significantly differ by arm (adjusted OR, 1.48; 95% CI, 0.72-3.02). The odds of using these techniques more after the curriculum did not significantly differ by arm between month 6 and month 15 (adjusted OR, 1.02; 95% CI, 0.57-1.82). The arm × period interaction term was statistically significant (P < .001) in multivariable longitudinal analyses conducted to test the effect of arm on reporting to know how to apply, belief in the benefit of, and having a positive attitude toward mindfulness; subsequent multivariable analyses stratified by period revealed that none of these outcomes significantly differed by arm at month 15.

In the sensitivity analyses in which time-dependent variables were removed, the results relating to intervention effects were similar to those described above and in the tables of our regression models.

Discussion

Our multicenter cluster randomized clinical trial of a novel mindfulness curriculum implemented early in pediatric internship found that the intervention did not significantly affect interns’ EE, depersonalization, burnout, personal accomplishment, mindfulness, or empathy immediately after curriculum implementation and 15 months later. After the 6-month curriculum was completed, MINdI participants were significantly more likely than controls to report knowing how to apply mindfulness techniques and their evidence, as well as having a positive attitude about mindfulness and believing it benefited their life. Fifteen months after curriculum implementation, the only measure with a statistically significant between-arm difference was in knowledge of the evidence supporting the use of mindfulness.

In contrast to prior studies14,15,17,18 of mindfulness curriculum, our study found no changes in burnout rates or levels of EE, depersonalization, mindfulness, or empathy between intervention and control participants. Our study intervention differs from prior studies14,15 in a number of important ways. First, our curriculum was not facilitated by an experienced mindfulness practitioner. Recognizing the limitation of facilitation by a local content expert on the feasibility of widespread dissemination of mindfulness curricula, our curriculum relied on a scripted curriculum that did not require a content expert to facilitate education. However, our results prompt us to question the potential effect of greater facilitator experience in mindfulness training on curriculum effectiveness.

Second, prior curricula have been more robust compared with MINdI.13,14,15,21,30,31 For example, the mindfulness-based stress reduction curriculum published by Krasner et al14 was composed of an 8-week intensive phase that included 2.5 hours per week and a 7-hour retreat followed by a 2.5-hour per month maintenance period for 10 months. In contrast, our 7-session monthly curriculum was specifically designed to integrate into preexisting residency didactic time. It is possible our curriculum may not have been robust enough to induce a change in behavior and objective metrics of burnout, mindfulness, or empathy, although changes in mindfulness-related knowledge and attitudes were apparent. Although programs were encouraged to take attendance, it was not required. Thus, we have no consistent data on how many training sessions each intern experienced. We wonder whether there could be a dose response in the mindfulness training that we are not able to assess in which more participation may have led to better outcomes among trainees.

In our study population, most participants in both arms had scores indicating burnout at baseline, and burnout worsened during the study period. Because most participants completed the baseline survey before internship began, efforts to reduce burnout among trainees should be integrated into undergraduate medical education. Despite reporting increased mindfulness-related knowledge and positive attitudes toward mindfulness after completing the curriculum, participants did not report corresponding increases in mindfulness practice or objective measures of mindfulness. Perhaps competing demands and priorities early in medical training, including a primary focus on increasing clinical competence, persistently outweighed prioritization of new self-care techniques to prevent burnout.

Finally, selection bias may have influenced prior cohort studies13,14,15,16 conducted among physicians who chose to participate in the mindfulness training that found mindfulness to be associated with decreased burnout. Small studies and those among medical trainees have often failed to show large or statistically significant effects of mindfulness on objective measures of burnout, empathy, or mindfulness.13,16,17,20,21,30

Limitations

This study has several limitations. First, cluster randomization resulted in an imbalance in gender and baseline personal accomplishment between study arms. Second, our study is limited by missing data, a common limitation that may introduce bias into the results; to address this, we estimated missing values by multiple imputation, which may have resulted in underestimation of SEs. Third, our sample size was based on power calculations that did not account for possible clustering by site. Thus, findings of clinical importance that were not statistically significant should be cautiously interpreted and their precision judged by the widths of their 95% CIs. Fourth, our pragmatic trial design allowed variation in month of the intervention and control experiences and survey implementation, so temporal trends in burnout during training may have influenced intervention efficacy and our findings.

The mixed results of our methodologically rigorous cluster randomized clinical trial of MINdI may indicate that trainees face unique challenges in integrating mindfulness knowledge into behavior change. The study demonstrated that improvements in mindfulness-related knowledge and attitudes failed to translate into effects on burnout, empathy, and mindfulness. Although we cannot be sure why the intervention did not have its intended effect, we hypothesize 2 explanations. First, although MINdI was robust enough to affect knowledge and attitudes, it was not strong enough to affect distal outcomes. Second, our study identified higher rates of burnout than previously reported in the literature of pediatric trainees. It is possible that the high levels of burnout we detected represent a meaningful temporal shift and the diminished efficacy of individual-level interventions, such as mindfulness, to address epidemic levels of burnout. Burnout in medical training may be driven more at a systems level than a personal one, and in the context of pediatric internship, efforts to reduce burnout should focus more on system reform than personal training.21,30,32

Conclusions

This multicenter cluster randomized clinical trial of a novel mindfulness curriculum demonstrated that the intervention did not significantly affect measures of burnout, mindfulness, or empathy among pediatric interns training across the US. However, intervention participants reported improved mindfulness-related knowledge, behaviors, and attitudes. The mixed results of this large, multicenter randomized clinical trial suggest that there is a need for further study, mechanism elucidation for behavior change, and curriculum optimization.

Supplement 1.

Trial Protocol

Supplement 2.

eTable. Study Sample and Lost to Follow-up Baseline Characteristics

Supplement 3.

Data Sharing Statement

References

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Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Supplementary Materials

Supplement 1.

Trial Protocol

Supplement 2.

eTable. Study Sample and Lost to Follow-up Baseline Characteristics

Supplement 3.

Data Sharing Statement


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