Most medical students begin to experience the full effect of their future profession for the first time during their clinical clerkships. These senior years of medical school, in which students rotate through different medical specialties, can be stressful because of the high workload and professional socialization process.1,2 Levels of overall psychological distress among U.S. and Canadian medical students are higher than in the general population and age-matched peers.3 Prevalence rates outside these two nations vary widely (12%–97%), and higher-quality studies report lower prevalences.4
Compared with psychological distress, there is a paucity of literature on positive mental health in medical students, although Dyrbye and colleagues suggest that positive mental health attenuates some adverse consequences of burnout.5 According to Ryff and Keyes,6 positive mental health consists of the six dimensions of psychological well-being: self-acceptance, positive relationships, autonomy, ability to master one’s environment, purpose in life, and personal growth. In later research, Keyes7 added aspects of emotional and social well-being to these dimensions. Keyes7,8 has shown repeatedly that positive mental health is not just the opposite of psychological distress but is actually an independent contributor to psychosocial functioning over and above psychological distress.
A possible intervention to reduce distress and increase positive mental health is mindfulness-based stress reduction training (MBSR), an eight-week group training program that teaches participants to be aware of bodily sensations, thoughts, and emotions in a curious, nonjudgmental attitude.9
Effects of MBSR on preclinical medical students have previously been examined by Shapiro and colleagues,10 who conducted a randomized waitlist controlled trial. Compared with the control group (n = 36), students who chose MBSR as an enrichment elective (n = 37) reported a significant reduction in depression, in both state and trait anxiety, and in psychological distress, plus a significant increase in empathy and spirituality.10 Authors of a second, nonrandomized, cohort-controlled study found a significant reduction in psychological distress in students who chose to participate in a 10-week MBSR seminar (n = 140) in comparison with those participating in a seminar on complementary medicine (n = 160).11 In both studies, the participants were self-selected, the response rates were modest, and the authors did not report follow-up data. A more recent randomized controlled trial conducted by Erogul and colleagues12 has reported less perceived stress and more self-compassion in students participating in MBSR (n = 30) than those allocated to the control group (n = 28); however, after six months, only the difference in self-compassion continued.
Two studies have focused on the effect of mindfulness on clinical clerkship students. Garneau and colleagues13 described a significant reduction in depression, emotional exhaustion, and perceived stress and a significant increase in self-compassion and mindfulness after a four-week mindfulness elective (n = 58); however, this study lacked both a control group and a follow-up. A set of investigators conducting a randomized controlled trial comparing the eight-week use of a 30-minute, CD-based mindfulness exercise with treatment as usual demonstrated a reduction of perceived stress, which was maintained at eight weeks post intervention.14 So far, to our knowledge, no authors have reported the effectiveness, including the long-term effectiveness, of the classical eight-week MBSR integrated into clinical clerkships.15–18
In their survey of 14 medical schools offering mindfulness training, Dobkin and Hutchinson17 reported that although such training might be useful, issues regarding timing, format, and long-term effect remained unresolved. In our current study, we have addressed some of these issues by examining the effects of MBSR on both psychological distress and positive mental health, by integrating the intervention into the existing curriculum, and by including long-term follow-up. We hypothesized that MBSR would reduce psychological distress and improve the positive mental health of clinical clerkship students.
Design and setting
We conducted a cluster-randomized controlled trial of MBSR during clinical clerkships versus clinical clerkships as usual (CAU) in first-year clinical clerkship students (who are similar to late second- or early third-year U.S. or Canadian students) of the Radboudumc in Nijmegen, the Netherlands (Figure 1). Recruitment took place between February 2011 and August 2012, and follow-up assessments lasted until May 2014. The medical curriculum in Nijmegen consists of three years of preclinical bachelor study and three years of master study, which involve rotating through a fixed order of hospital placements alternated with short periods of didactic classroom teaching.
We informed the students about the trial during classroom teaching in the fifth month of their clerkships. Interested students left their e-mail address and received an information leaflet by e-mail within two days, thus enabling them to decide to participate (or not) outside of the teaching environment free of any external pressure. Students did not receive any incentives for participation. Students unwilling to participate indicated their lack of interest by not leaving their e-mail address at the time of invitation, by not replying to the e-mail with the information leaflet, or by stating that they were not interested in participation in their reply to the invitation e-mail. We asked nonparticipants if they would be willing to complete the baseline assessment for the sake of assessing possible selection bias.
After providing informed consent, the students willing to participate in the trial completed an online baseline assessment, and we sent links to follow-up assessments 3, 7, 12, 15, and 20 months after baseline, during periods of didactic classroom teaching. We purposefully sent these assessments between (not during) clerkships to avoid variations in measures due to the nature of the clerkship. We did not inform instructors and supervisors of subsequent placements about student participation in the study, to preclude students from different groups being treated differently. The medical ethical research committee of Arnhem-Nijmegen approved the trial.
During the recruitment period, between February 2011 and August 2012, 232 students from 18 clerkship groups started their neurology clerkships in Nijmegen (where the MBSR was taught) and were eligible to participate in the study. Exclusion criteria were as follows:
- (1) under 18 years of age;
- (2) non–Dutch speaking; and
- (3) previous participation in MBSR.
One of us (the coordinating researcher, I.v.D.) was responsible for randomizing the groups by means of a computer-generated number every six months during the inclusion period. For the sake of feasibility and to integrate the intervention in the existing curriculum, we cluster-randomized students by their clerkship groups. The Faculty of Medicine determines the composition of groups (and, as a result, the timing of when students start their clerkships) based on a random allocation system which is not related to student performance. We did not inform students of their allocation to either the MBSR or CAU study group until all participants in each clerkship group had completed the online baseline assessment.
The intervention for the MBSR group consisted of eight weekly two-hour sessions (4:30 to 6:30 PM) which took place during the classroom teaching period (n = 2), the neurology clerkship (n = 4), and the psychiatry clerkship (n = 2). Appendix 1 provides a detailed description of the intervention, including Home Practice, and its similarities with and differences from the original MBSR. The MBSR was taught by a psychiatrist (A.E.M.S.) and a physician. Both teachers met the standards for UK good practice guidelines for teaching mindfulness-based courses19 and were not otherwise involved in the medical curriculum.
We measured the following mental health outcome measures using validated tools (see below): psychological distress (our primary outcome measure), positive mental health, life satisfaction, physician empathy, mindfulness skills, and dysfunctional cognitions. Students completed all the tools described below online.
Brief Symptom Inventory (BSI).
The BSI is a 53-item questionnaire that measures psychological distress in both clinical and nonclinical populations on a five-point Likert-type scale that ranges from 0 = “none at all” to 4 = “extremely.”20 The BSI is composed of nine primary symptom dimensions (somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism), which can be summarized in three global indices of distress (overall psychological distress level, intensity of symptoms, and number of symptoms). In this study, we have used the overall psychological distress level (Global Severity Index) as our outcome measure, which is the mean score of all 53 items. A higher score indicates a higher level of psychological distress.20 The Dutch BSI has been found to have a high reliability (α = 0.96) and high validity.21
Mental Health Continuum-Short Form (MHC-SF).
The 14-item MHC-SF measures emotional, psychological, and social well-being by means of questions such as “During the past month, how often did you feel that you liked most parts of your personality?” and “During the past month, how often did you feel that you had warm and trusting relationships with others?” Items are scored on a six-point Likert-type scale that ranges from 0 = “never” to 5 = “daily” (the total score can range from 0 to 70).7,8 A higher score indicates higher positive mental health. Studied in a representative sample of the Dutch population, internal reliability of the full MHC-SF has been high (α = 0.89) and validity good.22
Life Satisfaction Questionnaire (LiSat-9).
The LiSat-9 comprises a single item assessing overall life satisfaction and eight additional domain-specific items all scored on a six-point Likert-type scale, ranging from 1 = “very dissatisfied” to 6 = “very satisfied.” A higher score indicates a higher level of life satisfaction. The Dutch translation is used in healthy adults as well as different patient populations, mainly in rehabilitation. Studies using the LiSat-9 in different Dutch samples of rehabilitation patients have shown good validity and moderate to good reliability (α = 0.74–0.75).23–26
Jefferson Scale of Physician Empathy (JSPE).
The 20-item JSPE measures empathy in the physician–patient relationship. It contains statements such as “Patients feel better when their physicians understand their feelings.” Items are scored on a seven-point Likert-type scale, ranging from 1 = “strongly disagree” to 7 = “strongly agree.” The total score may range from 20 to 140, and higher scores indicate a higher level of empathy. Validity and reliability of the JSPE have been demonstrated to be high for physicians (α = 0.81–0.85) and medical students (α = 0.89).27–29
Five Facet Mindfulness Questionnaire (FFMQ).
The 39-item FFMQ assesses five domains of mindfulness skills: observing, describing, acting with awareness, nonjudging of inner experience, and nonreactivity to inner experience.30,31 Items are rated on a five-point Likert-type scale that ranges from 1 = “never or very rarely true” to 5 = “very often or always true,” such that the total score may range from 39 to 195. A higher score implies a higher level of mindfulness skills. The Dutch FFMQ has been shown to have good internal consistency (α = 0.85) and validity in a sample of Dutch nonmeditating students.32
Irrational Beliefs Inventory (IBI).
The 50-item IBI assesses dysfunctional cognitions, which are considered to be related to a person’s vulnerability for developing psychopathology.33 Items in five subscales (worrying, rigidity, need for approval, problem avoidance, and emotional irresponsibility) are rated on a five-point Likert scale that ranges from 1 = “strongly disagree” to 5 = “strongly agree.” The total score may range from 50 to 250, and a higher score indicates a higher level of dysfunctional cognitions. In a randomly selected Dutch university student sample, validity and reliability were satisfactory (α = 0.83–0.85).34
After the fourth and eighth MBSR sessions, students received an online questionnaire that asked how much time, on average, they had spent each week on home practice (see Appendix 1). They rated their time using the following five-point Likert-type scale:
- 0 = 0 minutes a day,
- 1 = 1–15 minutes a day,
- 2 = 16–30 minutes a day,
- 3 = 31–45 minutes a day,
- 4 = 46–60 minutes a day, and
- 5 = more than 60 minutes a day.
At every follow-up assessment, we asked students if they still practiced and if so, what kind of practice they performed.
We based our power calculation on results from our pilot study35 and the study of Jain and colleagues,36 who also measured psychological distress as a primary outcome measure by using the the Global Severity Index of the BSI. On the basis of the pilot study,35 the intraclass correlation coefficient of the Global Severity Index between the groups of students starting their clinical clerkships was 0.00 (negligible). Assuming a difference of 0.10 in Global Severity Index between the intervention and control group on the second measurement with a standard deviation of 0.25 in each group, 100 students per group would be necessary to realize a power of 80% with two-sided testing using a t test with an alpha of 0.05. Assuming a correlation of 0.5 between the baseline measurement and second measurement, 75 students per group would be necessary, 150 students in total.
We collected data using an online survey tool (Limesurvey, Hamburg, Germany). Using chi-square and independent-samples t tests, we compared baseline characteristics and outcome measures (1) between the MBSR and CAU students and (2) between students who dropped out of and remained in the study. We performed an intention-to-treat analysis of all students who had been randomized into one of the two conditions. We performed both a missing values analysis and Little’s missing completely at random test37 to examine whether data were missing at random or not. For all variables, we defined values exceeding 3.29 standard deviations from the mean as outliers and, as advised by Tabachnick and Fidell,38 transformed outlier data points to 3.29 times the standard deviation plus the mean. We applied multilevel mixed-effects models to all analyses to examine possible differences in the overall fluctuating change of our outcome measures over time between the intervention and control group. We determined the score on each outcome as a dependent variable, and we added gender and baseline level of the dependent variable as covariates. We defined a random intercept for clerkship group level as well as individual student level, and we defined time, condition (intervention or control group), and time × condition as fixed effects in the model. We used mixed-effects models analyses, as this technique makes use of all available data for each time point, including data from students lost to follow-up. We applied a sensitivity analysis by means of multiple imputations to examine if missing values influenced results. As it is not possible to calculate an overall effect size of the change in all six measurements, we computed effect sizes (Cohen’s d) of the 20-month measurement using group differences corrected for baseline. We considered d = 0.2 to be a small effect, d = 0.5 a moderate effect, and d = 0.8 a large effect. We performed all analyses using IBM SPSS Statistics for Windows, Version 21.0 (Armonk, New York), and we created our graphs using Microsoft Excel 2013 (Redmond, Washington).
Of 232 eligible students, 167 (72%) participated, and of these, we allocated 83 to the MBSR and 84 to CAU conditions (Figure 1). Of the 65 nonparticipants, 41 were nevertheless willing to complete a baseline assessment. Although the participants and nonparticipants did not differ in gender and age, participants did report higher levels of psychological distress and lower levels of positive mental health than nonparticipants.35
We have provided baseline characteristics of the MBSR and CAU participants in Table 1. We detected no significant differences in age, relationship status, or gender; nonetheless, we added gender as a confounder to the analyses because male students tended to be overrepresented in the MBSR as compared to the CAU group. Students were, on average, 23 years old, and the majority were female. During the eight-week training, students spent on average 1 to 15 minutes a day on home practice. The percentage of students practicing more than that gradually decreased over the course of the MBSR training from 40% in the second week to 16% in the last week. Only 3 students (4%) attended fewer than four sessions of the training. Of 73 students, 63 (86%) applied home practice at 3 months follow-up; and of 67 students, 33 (49%) applied home practice at 20 months’ follow-up. They mainly applied the “three-minute breathing space” and “deliberate awareness of routine activities” techniques.
At 20 months post intervention, 67 of 83 MBSR students (81%) and 58 of 84 CAU students (69%) had remained in the study. Students who dropped out of the study did not differ on baseline characteristics from those who remained in the study. Sensitivity analyses using multiple imputations to replace the missing values on all outcome measures revealed that missing values did not influence the overall result. Repeating all analyses without the 10 students who dropped out of the study after baseline (Figure 1) did not influence results either.
Effects of MBSR on mental health measures
Overall, students in the MBSR group reported lower levels on the primary outcome measure of psychological distress over the course of the 20-month follow-up period (P = .03, Cohen’s d = 0.20, see Table 2 and Figure 2). They also reported higher levels of positive mental health (P = .002, Cohen’s d = 0.44).
Effects of MBSR on other measures
Students in the MBSR group reported higher life satisfaction (P = .01, Cohen’s d = 0.51), more mindfulness skills (P = .05, Cohen’s d = 0.35), and less dysfunctional cognitions over the course of 20-month follow-up than those in the CAU group (P = .05, Cohen’s d = 0.18). The MBSR and CAU groups did not differ in physician empathy (P = .18, Cohen’s d = 0.27).
On the basis of our findings, MBSR integrated into clinical clerkships as part of the clinical curriculum resulted in a small reduction of psychological distress (Cohen’s d = 0.20) and a moderate increase in positive mental health (Cohen’s d = 0.44). In addition, the MBSR group reported a higher life satisfaction, more mindfulness skills, and less dysfunctional cognitions (Cohen’s d = 0.18–0.51) over the course of a 20-month follow-up period. We detected no effect of MBSR on self-reported empathy.
In contrast with previous studies which often comprised only self-referred samples,10,11,13 we offered MBSR to a consecutive sample of students as an integral part of their clinical clerkship curriculum. The percentage of medical students responding that they were willing to engage in an MBSR course was surprisingly high (72%). In addition, the dropout rate from the MBSR training was very low (4%), and follow-up rates were high.
The high attendance rate might have been influenced by the fact that the MBSR occurred during working hours, during the possibly less demanding neurology and psychiatry clerkships, and that the format and content had been adapted to the medical context. Still, these findings imply that integrating MBSR into clinical clerkships is feasible and that despite contending with high workload and long hours, clinical clerkship students find integrated MBSR training acceptable.
Although the finding—that an eight-week MBSR training results in consistent improvements even at a 20-month follow-up period—is certainly encouraging, the absolute differences between the MBSR and CAU group are small, especially given the wide range of some of the questionnaire scores. On the other hand, our measure of psychological distress officially ranges from 0 to 4, but in practice in nonclinical samples, the actual range is much smaller because the data distribution is highly skewed to the right and a cutoff of 0.58 is used for screening for psychopathology.21 Improvements in psychological distress in our student sample occurred within the normal, nonpathological range. Although not addressing psychopathology, this finding might still be relevant—for example, in students’ capability to cope with patient-care-related work stress. Further research should include this long-term perspective. To assess the clinical relevance better, outcome measures other than self-report questionnaires might be used; for example, investigators might use either blinded interviews to assess mental health or patient-rated measures to evaluate the professional attitude of students.
The small effect on psychological distress might be partly due to the lower baseline levels of distress in the participants of this study compared with medical students beginning their clinical rotations in the United States and Canada, offering less room for improvement. Although these relatively low levels of psychological distress could be explained by possible cultural differences or differences between medical curricula, a more important explanation could be that our consecutive study population might report less distress than the often selective self-referred populations of previous studies. This possibility aligns with the review of Hope and Henderson,4 who found that higher-quality studies reported a lower prevalence of psychological distress.
The finding that, in our sample, positive mental health improved more than psychological distress supports previous results that these are two related yet distinctive concepts, rather than two ends of the same continuum.7,8,22,39
Contrary to the findings of Krasner and colleagues40 in general practitioners, we did not find an effect of MBSR on self-reported empathy. This lack of effect might be explained by the different stage of professional development and the younger age of these students compared with the physicians in the Krasner study. In addition, several studies in medical students show that self-reported empathy does not correlate with observer- or patient-reported empathy.41–43
Strengths and limitations
To our knowledge, this is the only randomized controlled study of an eight-week MBSR course in clinical clerkship students. The integration of the MBSR into the clinical clerkships, the consecutive sample, the large sample size, the high response rate, the low dropout, and the 20-month follow-up are all important strengths of the study.
We also note some limitations. The study occurred in a single medical school in the Netherlands, which might limit generalizability, even though students were allocated for their clinical placements at different, affiliated hospitals in the region. Clinical clerkship students in Europe are usually younger than students in the United States and Canada, which could be another aspect limiting international generalizability. As the study lacked an active control condition, we cannot assume that effects are specifically related to the MBSR and not to peer support or attention. Social spread of the intervention to the control group (cross-contamination) seems unlikely as the cluster randomization prevented students from the intervention and control conditions taking classes together either during or after the training; however, we cannot guarantee that students did not have contact with each other and share information about MBSR, which could have reduced group differences.
Other factors that might have reduced group differences are the lack of booster sessions during the 20-month follow-up period and the fact that many students completed the 15-month follow-up assessment during a holiday, which started shortly after they received that questionnaire. Regarding the possible influence of seasonality, our inclusion period lasted 18 months, and measurements were scattered across all seasons; therefore, we believe seasonality had little to no effect on the results.
Although allocation of the groups was not concealed to the coordinating researcher (I.v.D.), we expect the impact of this lack of blinding on the results to be limited. The researcher had no knowledge of clerkship group composition at the time of randomization and therefore could not influence the allocation of specific students to a condition. In addition, scores on outcome measures could not be influenced as both baseline and follow-up assessments were completed online, without personal contact.
Finally, as our study focused on feasibility and integration of the intervention in the curriculum, we did not examine possible individual differences in response to the intervention. Future research will have to address this question.
Integrating MBSR training into the core curriculum of clinical clerkships appears to be both feasible and acceptable. Participating in this training resulted in a small to moderate improvement in the mental health of clinical clerkship students over a 20-month follow-up period. One of the key competencies listed in the CanMEDS physician competency framework for the professional role is demonstrating a commitment to physician health and well-being so as to foster optimal patient care.44 The development of competencies such as “exhibiting self-awareness,” “managing influence on personal well-being and professional performance,” and “managing personal and professional demands” are not usually addressed in clinical clerkships, which are mainly focused on developing knowledge and clinical skills. MBSR, however, specifically addresses these competencies and could therefore be a valuable part of the curriculum, supporting the development of students into balanced professionals. However, as this is, to our knowledge, the first randomized controlled trial of the eight-week MBSR with a long-term follow-up, replication studies with active control conditions and outcome measures assessing professional attitude are needed to strengthen the evidence supporting these assertions.
Acknowledgments: The authors wish to thank all students who participated in the study. They would also like to thank Mrs. Lea Peters-van Gemert, research assistant and quality officer, for her valuable contributions to data collection and processing and Martine Steen, MD, for her help in teaching the mindfulness-based stress reduction courses.
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Appendix 1 Information on Mindfulness-Based Stress Reduction Training (MBSR)
- Developed by Kabat-Zinn9 for use in patients with unexplained somatoform disorders
- Eight-week, 2.5-hour training with a fixed program
- Comprehensive folder containing an explanation of the exercises and home practice
- Formal exercises comprise body scan, sitting meditation, and mindful movement
- Informal exercises include awareness of breathing, awareness of routine activities such as eating, walking, cycling
- One-day silent retreat during the sixth week of the program
- Daily home practice with help of CDs/audio recordings comprising weekly alternating formal and informal exercises such as the body scan, sitting meditation, and awareness of routine activities
- Group dialogue and inquiry oriented around weekly in-session exercises and at-home assignments
Alterations to the curriculum used with first-year clinical clerkship students from Radboudumc, Nijmegen, the Netherlands
- Two-hour weekly program instead of 2.5 hours each week (therefore, some exercises were shorter)
- Addition of 10 minutes of interactive presentation each week related to the session theme (e.g., awareness of stress) with examples of (or examples of a lack of) mindful awareness in hospital daily practice
- No silent retreat
- Adaptation of the folder material for use in clinical clerkship students instead of patients, plus addition of examples related to clerkships and resources related to the session themes
Summary of weekly theme with core exercises and home practice
© 2017 by the Association of American Medical Colleges