Multi-modal mindfulness training and well-being for healthcare students.

INTRODUCTION: Mindfulness is a mental state attained through focusing awareness on the present with calm acceptance of thoughts, feelings, and bodily sensations. This study evaluated impact of mindfulness activities on well-being of pharmacy and other healthcare students. METHODS: Research participants completed pre- and post-intervention questionnaires evaluating multi-modal mindfulness interventions. Due to the pandemic, sessions led by a certified mindfulness instructor were offered live online and recorded, supplemented by a well-being mobile app and reflective discussion component. Four composite scales were administered to participants. The Brief Resilient Coping Scale (BRCS), Five Facet Mindfulness Questionnaire (FFMQ-15), Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS), and Depression Anxiety Stress Scales (DASS-21) inventories measured resilient coping skills, awareness, and psychological symptoms, including stress, depression, and anxiety. Exploratory factor analysis and Cronbach's alpha were used to determine scale reliability and validity. RESULTS: Thirty-six participants completed both pre- and post-intervention questionnaires (n = 36). Significant improvement was found in well-being for BRCS, FFMQ-15, and WEMWBS measures (P < .05). Change in DASS-21 was not significant (P = .19). Mobile app use enhanced foundational mindfulness skills. Awareness, connection, and coping themes were identified from written comments. CONCLUSIONS: Evaluation of this multi-modal interprofessional intervention provides further evidence of benefits of mindfulness for pharmacy and other healthcare students. The mobile app and mindful movement with reflection improved all attributes measured by the composite scales. Further research may explore alternative multi-modal mindfulness interventions and incorporation into healthcare education curricula. Interprofessional collaboration is encouraged among faculty to enhance mindfulness while connecting healthcare professionals.

Impact of an online training tool on individual and organizational resilience and mindfulness among radiological personnel in Norway.

BACKGROUND: Heavy workloads and increasing demands for productivity have contributed to rising rates of stress and burnout among radiological staff. Different forms of mindfulness and resilience-training might assist with stress management and protect these employees against burnout. AIM: The objective of this study is to evaluate the impact of an online training tool on individual and organizational resilience, mindfulness and quality of care. METHODS: An online questionnaire was used, consisting of the Connor-Davidson Resilience Scale, the Mindful Attention Awareness Scale, the Benchmark Resilience Tool, and questions pertaining to quality, safety, and burnout (baseline = 68 participants between July 2022 - October 2022, follow-up = 13 participants between November 2022 - February 2023). Descriptive statistics and a paired-sampled t-test were used for statistical analysis. RESULTS AND CONCLUSIONS: Few participants reported completing any of the exercises. The baseline group had significantly higher mean resilience (p = 0.018) and mindfulness scores (p = < 0.001), mean decrease in scores was 7.46 for resilience and 1.7 for mindfulness. In conclusion, both individual and organizational resilience are perceived as low among radiological personnel in Norway. However, it does not seem to affect quality and safety.

Self-care strategies for medical students: an uncontrolled mixed-methods evaluation of a mind-body-medicine group course.

BACKGROUND: High stress during medical education and its detrimental effects on student health is well documented. This exploratory evaluation study assesses a 10-week Mind-Body-Medicine student course, created to promote student self-care at Charité Universitätsmedizin Berlin, Germany. METHODS: During 2012-2019, uncontrolled quantitative and qualitative data were gathered from 112 student participants. Outcomes including changes in perceived stress (PSS), mindfulness (FMI/MAAS), self-reflection (GRAS), self-efficacy (GSE), empathy (SPF), and health-related quality of life (SF-12) were measured between the first (T0) and last sessions (T1). Qualitative data were obtained in focus groups at course completion and triangulated with quantitative data. RESULTS: Quantitative outcomes showed decreases in perceived stress and increased self-efficacy, mindfulness, self-reflection, and empathy. In focus groups, students reported greater abilities to self-regulate stressful experiences, personal growth and new insights into integrative medicine. Triangulation grounded these effects of MBM practice in its social context, creating an interdependent dynamic between experiences of self and others. CONCLUSION: After completing an MBM course, students reported reduced perceived stress, increased self-efficacy, mindfulness, empathy and positive engagement with integrative concepts of doctor-patient relationships. Further research with larger randomized confirmatory studies is needed to validate these benefits.

Mindfulness and Academic Performance of College and University Students: A Systematic Review.

Higher education's expectations place demands on students' attainment, leading them to experience stress and anxiety, which negatively affect their academic improvement and life satisfaction. The aim of this systematic review was to investigate (a) if mindfulness as an inner ability is related to academic attainment, through dependent variables, including compassion, engagement, stress or anxiety state, depression, self-efficacy, mindfulness's facets (non-reactivity, acting with awareness) and (b) if mindfulness-based interventions positively affect the academic performance of college and university students. The systematic review was conducted in accordance with the PRISMA statement. PubMed, Web of Science, and Cochrane Library Wiley were screened to identify studies published relevant to the topic. In total, 568 papers were retrieved in the initial search. Five papers met the eligibility criteria and were included in the systematic review: a randomized controlled trial, a non-randomized controlled trial, a quasi-experimental study, a quantitative exploratory pilot study, and a longitudinal randomized controlled study. Most interventional studies revealed a non-significant direct effect of practicing mindfulness technique on academic attainment. Further research, especially randomized controlled trials are necessary to clarify the effect of mindfulness on academic performance of college and university students.

Effectiveness and mechanisms of change of a mindfulness-based intervention on elementary school children: A cluster-randomized control trial.

Mindfulness-based interventions (MBIs) in the school context are increasingly widespread worldwide. The present study evaluates the effectiveness of a school-MBI (GrowingUp Breathing program) on children's socio-emotional and academic development. Three hundred thirteen elementary students from 7 to 12 years old from two schools in Madrid (Spain) participated. A cluster-randomized control trial was designed, assigning eight classrooms to the MBI-group (N = 155) and eight classrooms to the waiting-list control group (N = 158). Measures were evaluated at pre- and post-intervention in both groups and a 3-month follow-up was collected in the MBI-group. Children self-reported their mindfulness skills (i.e., dispositional mindfulness and psychological inflexibility) and well-being (i.e., anxiety and life satisfaction) and teachers evaluated children's social-emotional competence (i.e., emotion regulation, peer-relationship problems, and prosociality), well-being (i.e., emotional symptoms), and academic competence (i.e., student engagement and academic achievement). Mindfulness skills and emotional regulation were examined as potential mediators. Results revealed that children who received the MBI, compared to children in the WLC-group, improved their mindfulness skills, emotion regulation, prosociality, and emotional and behavioral engagement and decreased anxiety and peer-relationship problems. Positive changes in dispositional mindfulness led to reductions in children's anxiety and psychological inflexibility. Positive changes in emotional regulation led to improvements in prosociality and student engagement and decreased peer-relationships problems and emotional symptoms. Therefore, the results showed that a brief-MBI integrated in the Spanish regular school curriculum enhanced children's socio-emotional and academic development. Dispositional mindfulness and emotion regulation work as processes of change that underlie the intervention's impact.

Understanding students' motivations for participating in a mindfulness course: a qualitative analysis of medical students' views.

OBJECTIVES: Improving medical students' wellbeing and empowerment through curricular activities is a topic of interest worldwide. Mindfulness-based interventions (MBIs) are increasingly implemented in medical education often as part of elective courses. To better understand training outcomes and adjust curriculum to students' needs, we will explore why will medical students participate in meditation-based education? METHODS: We analyzed 29 transcripts from the first session of an 8-week MBSR program offered to medical students in French. Transcripts were coded and analyzed using a qualitative content thematic analysis and the constant comparison method. RESULTS: Analyses resulted in three themes describing students' motivation: (1) Medical education and the physician's role, i.e. improving interpersonal skills, acquiring skills oriented toward a more integrative medicine, being more productive in a highly competitive context. (2) Caring for my health i.e. aiming at stress reduction, emotion regulation, and improving self-compassion. (3) A quest for meaning, i.e. optimizing meaning of care, and meaning of life. CONCLUSION: The results highlight the congruence between the perceived motivations and the evidence on the effect of mindfulness on self-care, the development of humanistic medical skills, and the meaning of care. Some findings raise the issue of the limits of using mindfulness to enhance one's productivity. Notably, participants articulated the need for self-care as in mindfulness training, with the ability to care for others.

Measuring the Effectiveness of a Multicomponent Program to Manage Academic Stress through a Resilience to Stress Index.

In this work, we evaluate the effectiveness of a multicomponent program that includes psychoeducation in academic stress, mindfulness training, and biofeedback-assisted mindfulness, while enhancing the Resilience to Stress Index (RSI) of students through the control of autonomic recovery from psychological stress. Participants are university students enrolled in a program of excellence and are granted an academic scholarship. The dataset consists of an intentional sample of 38 undergraduate students with high academic performance, 71% (27) women, 29% (11) men, and 0% (0) non-binary, with an average age of 20 years. The group belongs to the "Leaders of Tomorrow" scholarship program from Tecnológico de Monterrey University, in Mexico. The program is structured in 16 individual sessions during an eight-week period, divided into three phases: pre-test evaluation, training program, and post-test evaluation. During the evaluation test, an assessment of the psychophysiological stress profile is performed while the participants undergo a stress test; it includes simultaneous recording of skin conductance, breathing rate, blood volume pulse, heart rate, and heart rate variability. Based on the pre-test and post-test psychophysiological variables, an RSI is computed under the assumption that changes in physiological signals due to stress can be compared against a calibration stage. The results show that approximately 66% of the participants improved their academic stress management after the multicomponent intervention program. A Welch's t-test showed a difference in mean RSI scores (t = -2.30, p = 0.025) between the pre-test and post-test phases. Our findings show that the multicomponent program promoted positive changes in the RSI and in the management of the psychophysiological responses to academic stress.

Development and Evaluation of a Blended Learning Mindfulness Program for High School Students During the COVID-19 Pandemic.

Many adolescents worldwide suffer from stress or unhealthy emotional states such as depression. There is a trend toward limited physical contact via social distancing practices that developed during the coronavirus disease 2019 (COVID-19) pandemic. An experimental study aimed at investigating the effects of a mindfulness program on stress, concentration, self-esteem, and self-control in high school students. A 10-week mindfulness intervention was provided to the experimental group (n = 89) from September-November 2020, while the control group (n = 89) received general health education. Four weeks after the program, the experimental group showed reduced stress and improved concentration, self-esteem, and self-control compared to baseline.The blended learning mindfulness program is effective improving concentration and should be incorporated into the formal high school curriculum.

The impact of a mindfulness bracelet on emotional affect in medical students: a prospective cohort study.

BACKGROUND: There is concern that negative changes in emotional outlook among medical students may impair the behavior of students, diminish learning, and ultimately affect patient care. Although most medical students begin their professional education with idealism, enthusiasm, and attention to humanity, they often have difficulty balancing their happiness with social and professional responsibilities. The following study aimed to determine if a simple mindfulness reminder (in the form of a bracelet) will impact emotional affect in first-year medical students. The second aim is to better understand the changes in emotional affect as students start medical school. METHODS: First year medical students were invited to participate at the start of the academic year. Baseline survey data and demographic data were obtained prior to participants being given the mindfulness bracelet and a standardized presentation explaining its purpose. Follow-up surveys were obtained at one- and two-month intervals. Statistical analysis was based on sum score of the survey. Change of sum score over time was tested by using repeated measurement analysis. RESULTS: Data collection included 104 students at the initial distribution of the survey. Follow-up surveys were obtained from 78 and 69 students at the first- and second-month mark, respectively. No significant associations were detected between frequency of mindfulness bracelet usage and emotional affect. However, there was a significant decrease in positive affect over the first month of medical school (p < 0.01), followed by a significant recovery in positive affect in the second month of medical school (p < 0.01). Demographic data did not reveal statistically significant differences among demographic groups and progression of emotional affect. CONCLUSIONS: Although the mindfulness bracelet intervention did not yield significant improvement in emotional affect, our results are consistent with other studies demonstrating that the first year of medical school negatively impacts the emotional outlook of students. Future studies are needed to explore practical interventions and to better understand and address the negative effect that early medical school education has on student's emotional state.

Exploring the effects of a smartphone-based meditation app on stress, mindfulness, well-being, and resilience in pharmacy students.

PURPOSE: The purpose of this study was to investigate the effects of the smartphone-based meditation app Ten Percent Happier on stress, mindfulness, well-being, and resilience in pharmacy students. METHODS: Pharmacy students in a professional year of study were recruited to participate. Students were instructed to meditate using the Ten Percent Happier app for at least 5 days a week for 4 weeks. Students could use the app at their discretion for weeks 5 to 12. Baseline, week 4, and week 12 responses were collected from the following instruments: the Perceived Stress Scale, the Five-Facet Mindfulness Questionnaire-15, the Flourishing Scale, and the Brief Resilience Scale. RESULTS: Eighty-nine pharmacy students volunteered for the study. Sixty (67%) enrolled by completing the baseline survey. Of these, 28 (47%) completed the week 4 survey and 22 (37%) completed the week 12 survey. Participants experienced a reduction in perceived stress (P = 0.0005) and increases in resilience (P < 0.0001) and well-being (P = 0.0006). Increases in mindfulness were seen in 4 of the 5 subscales of the Five-Facet Mindfulness Questionnaire-15 (P ≤ 0.05). These benefits were noted at week 4 and maintained at week 12. CONCLUSION: Pharmacy students who practiced mindful meditation through the Ten Percent Happier app for an average of 5 days a week for 4 weeks experienced reduced stress and improved mindfulness, well-being, and resilience. Benefits experienced during the intervention were maintained at the 8-week follow-up, despite app usage decreasing to an average of 4 days a week.

Mindfulness-Based Student Training Improves Vascular Variability Associated With Sustained Reductions in Physiological Stress Response.

In today's fast-paced society, chronic stress has become an increasing problem, as it can lead to psycho-physiological health problems. University students are also faced with stress due to the demands of many courses and exams. The positive effects of mindfulness-based stress reduction (MBSR) on stress management and self-regulation have already been studied. We have developed a new mindfulness intervention tailored for students-the Mindfulness-Based Student Training (MBST). In this study, we present longitudinal results of the MBST evaluation. Biosignal analysis methods, including pulse wave variability (PWV), heart rate variability, and respiratory activity, were used to assess participants' state of autonomic regulation during the 12-week intervention and at follow-up. The progress of the intervention group (IGR, N = 31) up to 3 months after the end of MBST was compared with that of a control group (CON, N = 34). In addition, the long-term effect for IGR up to 1 year after intervention was examined. The analysis showed significant positive changes in PWV exclusively for IGR. This positive effect, particularly on vascular function, persists 1 year after the end of MBST. These results suggest a physiologically reduced stress level in MBST participants and a beneficial preventive health care program for University students.

The Impact of Mindfulness on Stress and Burnout of New Graduate Nurses as a Component of a Nurse Residency Program.

OBJECTIVE: This evidence-based practice project assessed the impact of integrating mindfulness training into an existing nurse residency program. BACKGROUND: Stress and burnout are endemic in healthcare. The transition to practice is associated with stress and anxiety for newly graduated nurses. Evidence supports mindfulness-based interventions to mitigate stress and burnout and improve the workplace environment and patient outcomes. METHODS: This project employed a pre/post design to measure burnout, stress, and mindfulness, comparing means and standard deviations between intervention and comparison nurse residency cohorts. Mindfulness training was integrated at 4 points within the 1st 6 months of the residency program. RESULTS: The intervention cohort reported significantly less burnout and stress and more mindfulness at 6 months than the comparison group. CONCLUSIONS: Mindfulness training can be feasibly integrated into an existing nurse residency program to decrease stress and burnout for new graduate nurses during the transition to practice.

Effect of a Novel Mindfulness Curriculum on Burnout During Pediatric Internship: A Cluster Randomized Clinical Trial.

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.

Evaluating the effects of a mindfulness mobile application on student pharmacists' stress, burnout, and mindfulness.

PURPOSE: Pharmacists report high levels of burnout. Mindfulness approaches have been demonstrated to have positive results in the general population and in other healthcare professions. However, limited studies have been performed evaluating mindfulness approaches in student pharmacists. The aim of this study was to evaluate the effectiveness of daily use of a mindfulness mobile application in improving student pharmacists' perceived stress, burnout, and mindfulness. METHODS: This study was a randomized, longitudinal, waitlist-controlled trial. The intervention group was asked to meditate using the mindfulness application Headspace daily for at least 6 weeks. The waitlist control group was asked to abstain from using the application for the entire study. Stress, burnout, and mindfulness were assessed using validated survey instruments at baseline, 6 weeks, and 10 weeks. A secondary outcome was to assess the persistence of application use after the intervention period. RESULTS: Fifty-six participants completed the study. The intervention group reported significantly lower scores on stress and burnout at 6 weeks compared to the control group. The intervention group also reported significantly higher scores on mindfulness. The differences in stress, burnout, and mindfulness persisted at follow-up. The mean percentage of students in the intervention group who used the application each day was 90% over the intervention period and 62% over the follow-up period. CONCLUSION: A mindfulness mobile application significantly improved student pharmacists' stress, burnout, and mindfulness with daily use. Most participants continued to use the application for 4 weeks after the end of the intervention. Positive effects on stress and mindfulness persisted even with decreased use.

The Feasibility of a School Nurse-Led Mindfulness Program.

The purpose of this study was to evaluate the feasibility of a school nurse-led mindfulness program in a public school. Elementary students in an urban public school system are exposed to many stressors including poverty, family disturbances, and mental health conflicts. Previous research suggests that mindfulness interventions given by teachers promote prosocial behavior and stress reduction; however, there are no studies that have determined whether the school nurse could lead the program. A pre- to posttest design was employed using school-aged children enrolled in the fourth grade who were administered a mindfulness program. The participants were assessed for emotional states before and after the intervention. A total of 12 students completed the intervention. Students found the mindfulness program to be helpful, and the school nurse may be able to successfully complete the intervention. With appropriate planning, school nurses may be able to successfully implement the mindfulness curriculum in an urban public school.

Reducing Stress and Increasing Mindfulness in Nursing Students: An Online Mindfulness Intervention Study.

ABSTRACT: This pilot study evaluated the outcomes of stress and mindfulness among a convenience sample ( n = 60) of nursing students. Students participated in an online mindfulness-based intervention and completed the Perceived Stress Scale and the Five Facet Mindfulness Questionnaire. Although mean stress scores lowered, there was no statistically significant reduction in stress. There were significant increases in mindfulness scores (posttest, p = .000) that were sustained at four-week follow-up ( p = .012). Larger increases in mindfulness were associated with larger decreases in stress.

Brief Mindfulness Practice Course for Healthcare Providers.

OBJECTIVE: The aim of this study was to examine the short-term and sustained effect on well-being, burnout, and mindful awareness of an abbreviated mindfulness practice course designed for nurses and other healthcare professionals. BACKGROUND: Most mindfulness programs are impractical for frontline healthcare providers because of the intensive, off-site initial training and prolonged practice commitment. A psychiatric nurse educator developed a brief training program tailored for healthcare providers. METHODS: Two institutional review board-approved studies examined the abbreviated mindfulness practice course for healthcare providers: the first, a single-group pretest-posttest design with 25 nursing employees in an academic medical center, and the second, a randomized controlled trial with 83 healthcare professionals. RESULTS: Significant improvement in mindful awareness and at least 1 indicator of burnout were demonstrated. Improvements in quality of life were noted with nurses. CONCLUSIONS: Findings support the short-term and sustained impact of this brief mindfulness curriculum on mindful awareness, quality of life, and aspects of burnout for healthcare professionals.

[How can mindfulness contribute to health care?] / Wat kan mindfulness bijdragen aan de gezondheidszorg?

Mindfulness-Based Interventions (MBIs) are increasingly applied in both mental and somatic health care. MBIs have been proven effective in patients with psychiatric problems and chronic somatic conditions.. MBIs can help (future) health care professionals as well. Despite their effectiveness, the implementation of MBIs in healthcare lags behind. Implementation is facilitated by integration of MBIs in the clinical care and education of medical doctors, an adequate number of qualified mindfulness teachers and robust clinical research into the effectiveness and working mechanisms of MBIs.

Impact of a Resiliency Training to Support the Mental Well-being of Front-line Workers: Brief Report of a Quasi-experimental Study of the Community Resiliency Model.

BACKGROUND: Front-line workers (FLW) are at risk for secondary traumatic stress, burnout, and related psychiatric sequelae: depression, anxiety, suicidality, posttraumatic stress disorder, and sleep and substance use disorders. FLW are in need of self-care programs to support their mental health. METHODS: Quasi-experimental study to assess the impact of a simple mental well-being and emotional regulation training, the Community Resiliency Model (CRM), using a convenience sample of FLW. Baseline scores of mental well-being and stress measures were compared with follow-up scores at 3 time points. Outcomes were psychological wellness (World Health Organization-5 Well-being Index); resilience (Connor-Davidson Resilience Scale-10); traumatic stress (Secondary Traumatic Stress Scale); physical symptoms (Somatic Symptom Scale-8). RESULTS: Of the 104 participants who enrolled and attended the CRM training, 73 (70.2%) completed at least 1 posttest. Well-being scores increased at 1 year with a small-moderate effect size (Cohen d=0.32). Resilience scores increased with a small-moderate effect size by 1 year (Cohen d=0.36). Secondary traumatic stress scores declined, with the largest effect at 1 week (Cohen d=0.49). Somatic symptoms decreased at each posttest, with the largest change occurring from baseline to 1 week (d=0.39). Participants reported an awareness of body sensations helped them when overwhelmed as a means of calming themselves. CONCLUSIONS: After a 3-hour CRM training, participants reported improved mental well-being and decreased secondary traumatic stress and somatic symptoms. This simple body awareness intervention may be a good resource during the COVID-19 pandemic.

Update to the effectiveness and cost-effectiveness of a mindfulness training programme in schools compared with normal school provision (MYRIAD): study protocol for a randomised controlled trial.

BACKGROUND: MYRIAD (My Resilience in Adolescence) is a superiority, parallel group, cluster randomised controlled trial designed to examine the effectiveness and cost-effectiveness of a mindfulness training (MT) programme, compared with normal social and emotional learning (SEL) school provision to enhance mental health, social-emotional-behavioural functioning and well-being in adolescence. The original trial protocol was published in Trials (accessible at https://doi.org/10.1186/s13063-017-1917-4 ). This included recruitment in two cohorts, enabling the learning from the smaller first cohort to be incorporated in the second cohort. Here we describe final amendments to the study protocol and discuss their underlying rationale. METHODS: Four major changes were introduced into the study protocol: (1) there were changes in eligibility criteria, including a clearer operational definition to assess the degree of SEL implementation in schools, and also new criteria to avoid experimental contamination; (2) the number of schools and pupils that had to be recruited was increased based on what we learned in the first cohort; (3) some changes were made to the secondary outcome measures to improve their validity and ability to measure constructs of interest and to reduce the burden on school staff; and (4) the current Coronavirus Disease 2019 (SARS-CoV-2 or COVID-19) pandemic both influences and makes it difficult to interpret the 2-year follow-up primary endpoint results, so we changed our primary endpoint to 1-year follow-up. DISCUSSION: These changes to the study protocol were approved by the Trial Management Group, Trial Steering Committee and Data and Ethics Monitoring Committees and improved the enrolment of participants and quality of measures. Furthermore, the change in the primary endpoint will give a more reliable answer to our primary question because it was collected prior to the COVID-19 pandemic in both cohort 1 and cohort 2. Nevertheless, the longer 2-year follow-up data will still be acquired, although this time-point will be now framed as a second major investigation to answer some new important questions presented by the combination of the pandemic and our study design. TRIAL REGISTRATION: International Standard Randomised Controlled Trials ISRCTN86619085 . Registered on 3 June 2016.