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      Controlled clinical trial comparing the effectiveness of a mindfulness and self-compassion 4-session programme versus an 8-session programme to reduce work stress and burnout in family and community medicine physicians and nurses: MINDUUDD study protocol

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          Abstract

          Background

          Health personnel are susceptible to high levels of work stress and burnout due to the psychological and emotional demands of their work, as well as to other aspects related to the organisation of that work. This paper describes the rationale and design of the MINDUUDD study, the aim of which is to evaluate the effectiveness of a mindfulness and self-compassion 4-session programme versus the standard 8-session programme to reduce work stress and burnout in Family and Community Medicine and Nursing tutors and residents.

          Methods

          The MINDUDD study is a multicentre cluster randomised controlled trial with three parallel arms. Six Teaching Units will be randomised to one of the three study groups: 1) Experimental Group-8 (EG8); 2) Experimental Group-4 (EG4) Control group (CG). At least 132 subjects will participate (66 tutors/66 residents), 44 in the EG8, 44 in the EG4, and 44 in the CG. Interventions will be based on the Mindfulness-Based Stress Reduction (MBSR) program, including some self-compassion practices of the Mindful Self-Compassion (MSC) programme. The EG8 intervention will be implemented during 8 weekly face-to-face sessions of 2.5 h each, while the EG4 intervention will consist of 4 sessions of 2.5 h each. The participants will have to practice at home for 30 min/day in the EG8 and 15 min/day in the EG4. The Five Facet Mindfulness Questionnaire (FFMQ), Self-Compassion Scale (SCS), Perceived Stress Questionnaire (PSQ), Maslach Burnout Inventory (MBI), Jefferson Scale of Physician Empathy (JSPE), and Goldberg Anxiety-Depression Scale (GADS) will be administered. Measurements will be taken at baseline, at the end of the programs, and at three months after completion. The effect of the interventions will be evaluated by bivariate and multivariate analyses (Multiple Linear Regression).

          Discussion

          If the abbreviated mindfulness programme is at least as effective as the standard program, its incorporation into the curriculum and training plans will be easier and more appropriate. It will also be more easily applied and accepted by primary care professionals because of the reduced resources and means required for its implementation, and it may also extend beyond care settings to academic and teaching environments as well.

          Trial registration

          The study has been registered at ClinicalTrials.gov ( NCT03629457; date of registration: 13.08.2018).

          Electronic supplementary material

          The online version of this article (10.1186/s12875-019-0913-z) contains supplementary material, which is available to authorized users.

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          Most cited references29

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          Association of an educational program in mindful communication with burnout, empathy, and attitudes among primary care physicians.

          Michael Krasner, Ronald M Epstein, Howard Beckman … (2009)
          Primary care physicians report high levels of distress, which is linked to burnout, attrition, and poorer quality of care. Programs to reduce burnout before it results in impairment are rare; data on these programs are scarce. To determine whether an intensive educational program in mindfulness, communication, and self-awareness is associated with improvement in primary care physicians' well-being, psychological distress, burnout, and capacity for relating to patients. Before-and-after study of 70 primary care physicians in Rochester, New York, in a continuing medical education (CME) course in 2007-2008. The course included mindfulness meditation, self-awareness exercises, narratives about meaningful clinical experiences, appreciative interviews, didactic material, and discussion. An 8-week intensive phase (2.5 h/wk, 7-hour retreat) was followed by a 10-month maintenance phase (2.5 h/mo). Mindfulness (2 subscales), burnout (3 subscales), empathy (3 subscales), psychosocial orientation, personality (5 factors), and mood (6 subscales) measured at baseline and at 2, 12, and 15 months. Over the course of the program and follow-up, participants demonstrated improvements in mindfulness (raw score, 45.2 to 54.1; raw score change [Delta], 8.9; 95% confidence interval [CI], 7.0 to 10.8); burnout (emotional exhaustion, 26.8 to 20.0; Delta = -6.8; 95% CI, -4.8 to -8.8; depersonalization, 8.4 to 5.9; Delta = -2.5; 95% CI, -1.4 to -3.6; and personal accomplishment, 40.2 to 42.6; Delta = 2.4; 95% CI, 1.2 to 3.6); empathy (116.6 to 121.2; Delta = 4.6; 95% CI, 2.2 to 7.0); physician belief scale (76.7 to 72.6; Delta = -4.1; 95% CI, -1.8 to -6.4); total mood disturbance (33.2 to 16.1; Delta = -17.1; 95% CI, -11 to -23.2), and personality (conscientiousness, 6.5 to 6.8; Delta = 0.3; 95% CI, 0.1 to 5 and emotional stability, 6.1 to 6.6; Delta = 0.5; 95% CI, 0.3 to 0.7). Improvements in mindfulness were correlated with improvements in total mood disturbance (r = -0.39, P < .001), perspective taking subscale of physician empathy (r = 0.31, P < .001), burnout (emotional exhaustion and personal accomplishment subscales, r = -0.32 and 0.33, respectively; P < .001), and personality factors (conscientiousness and emotional stability, r = 0.29 and 0.25, respectively; P < .001). Participation in a mindful communication program was associated with short-term and sustained improvements in well-being and attitudes associated with patient-centered care. Because before-and-after designs limit inferences about intervention effects, these findings warrant randomized trials involving a variety of practicing physicians.
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            Effects of low-dose mindfulness-based stress reduction (MBSR-ld) on working adults.

            James Klatt, Janet Buckworth, W Malarkey (2009)
            Mindfulness-based stress reduction (MBSR) has produced behavioral, psychological, and physiological benefits, but these programs typically require a substantial time commitment from the participants. This study assessed the effects of a shortened (low-dose [ld]) work-site MBSR intervention (MBSR-ld) on indicators of stress in healthy working adults to determine if results similar to those obtained in traditional MBSR could be demonstrated. Participants were randomized into MBSR-ld and wait-list control groups. Self-reported perceived stress, sleep quality, and mindfulness were measured at the beginning and end of the 6-week intervention. Salivary cortisol was assessed weekly. Significant reductions in perceived stress (p = .0025) and increases in mindfulness (p = .0149) were obtained for only the MBSR-ld group (n = 22). Scores on the global measure of sleep improved for the MBSR-ld group (p = .0018) as well as for the control group (p = .0072; n = 20). Implications and future research are discussed.
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              Validation of the Spanish versions of the long (26 items) and short (12 items) forms of the Self-Compassion Scale (SCS)

              Javier Garcia-Campayo, Mayte Navarro-Gil, Eva Andrés … (2014)
              Background Self-compassion is a key psychological construct for assessing clinical outcomes in mindfulness-based interventions. The aim of this study was to validate the Spanish versions of the long (26 item) and short (12 item) forms of the Self-Compassion Scale (SCS). Methods The translated Spanish versions of both subscales were administered to two independent samples: Sample 1 was comprised of university students (n = 268) who were recruited to validate the long form, and Sample 2 was comprised of Aragon Health Service workers (n = 271) who were recruited to validate the short form. In addition to SCS, the Mindful Attention Awareness Scale (MAAS), the State-Trait Anxiety Inventory–Trait (STAI-T), the Beck Depression Inventory (BDI) and the Perceived Stress Questionnaire (PSQ) were administered. Construct validity, internal consistency, test-retest reliability and convergent validity were tested. Results The Confirmatory Factor Analysis (CFA) of the long and short forms of the SCS confirmed the original six-factor model in both scales, showing goodness of fit. Cronbach’s α for the 26 item SCS was 0.87 (95% CI = 0.85-0.90) and ranged between 0.72 and 0.79 for the 6 subscales. Cronbach’s α for the 12-item SCS was 0.85 (95% CI = 0.81-0.88) and ranged between 0.71 and 0.77 for the 6 subscales. The long (26-item) form of the SCS showed a test-retest coefficient of 0.92 (95% CI = 0.89–0.94). The Intraclass Correlation (ICC) for the 6 subscales ranged from 0.84 to 0.93. The short (12-item) form of the SCS showed a test-retest coefficient of 0.89 (95% CI: 0.87-0.93). The ICC for the 6 subscales ranged from 0.79 to 0.91. The long and short forms of the SCS exhibited a significant negative correlation with the BDI, the STAI and the PSQ, and a significant positive correlation with the MAAS. The correlation between the total score of the long and short SCS form was r = 0.92. Conclusion The Spanish versions of the long (26-item) and short (12-item) forms of the SCS are valid and reliable instruments for the evaluation of self-compassion among the general population. These results substantiate the use of this scale in research and clinical practice.
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                Author and article information

                Contributors
                Luis-Angel Pérula-de Torres:
                ORCID: http://orcid.org/0000-0002-8784-4905
                +34 659681627 , luisangel.perula@gmail.com
                Juan Carlos Verdes-Montenegro Atalaya: juancarlosverdesm@yahoo.es
                Javier García-Campayo: jgarcamp@gmail.com
                Ana Roldán-Villalobos: aroldanvi@gmail.com
                Rosa Magallón-Botaya: med000764@gmail.com
                Cruz Bartolomé-Moreno: cbartolomem@hotmail.com
                Herminia Moreno-Martos: partaloa@gmail.com
                Elena Melús-Palazón: emelusp@gmail.com
                Norberto Liétor-Villajos: norberto.lietor.sspa@juntadeandalucia.es
                Francisco Javier Valverde-Bolívar: fjvalverdebolivar@hotmail.com
                Nur Hachem-Salas: nurhachem@gmail.com
                Luis-Alberto Rodríguez: larodrigueza@saludcastillayleon.es
                Mayte Navarro-Gil: maytenavarrogil@gmail.com
                Ronald Epstein: Ronald_Epstein@urmc.rochester.edu
                Antonio Cabezón-Crespo: acabezon@saludcastillayleon.es
                Carmen Morillo-Velarde Moreno: cmorillovelardem@gmail.com
                Journal
                Journal ID (nlm-ta): BMC Fam Pract
                Journal ID (iso-abbrev): BMC Fam Pract
                Title: BMC Family Practice
                Publisher: BioMed Central (London )
                ISSN (Electronic): 1471-2296
                Publication date (Electronic): 6 February 2019
                Publication date PMC-release: 6 February 2019
                Publication date Collection: 2019
                Volume: 20
                Electronic Location Identifier: 24
                Affiliations
                [1 ]ISNI 0000 0004 0445 6160, GRID grid.428865.5, Clinical and Epidemiological Research Group in Primary Care (GICEAP), , IMIBIC/Reina Sofía University Hospital/University of Córdoba, Primary Care Prevention and Health Promotion Research Network (RedIAPP), Family and Community Medicine Teaching Unit of Córdoba, ; Córdoba, Spain
                [2 ]Comuneros Health Center, Research Network on Communication and Health (RICyS) of the Communication and Health program (semFYC), Burgos, Spain
                [3 ]Primary Care Prevention and Health Promotion Research Network (RedIAPP), Centre for Biomedical Research Network on Mental Health, Zaragoza, Spain
                [4 ]Miguel Servet Hospital, University of Zaragoza, Zaragoza, Spain
                [5 ]ISNI 0000 0004 0445 6160, GRID grid.428865.5, Clinical and Epidemiological Research Group in Primary Care (GICEAP), , IMIBIC/Reina Sofía University Hospital/University of Córdoba. Family and Community Medicine Teaching Unit of Córdoba, ; Córdoba, Spain
                [6 ]ISNI 0000 0001 2152 8769, GRID grid.11205.37, Arrabal Health Centre. Primary Care Prevention and Health Promotion Research Network (RedIAPP), , University of Zaragoza, Health Research Institute of Aragón, ; Zaragoza, Spain
                [7 ]Family and Community Care Teaching Unit of Zaragoza Sector I, Zaragoza, Spain
                [8 ]UGC Almería Periphery. Retamar Health Center, Research Network on Communication and Health (RICyS) of the Program Communication and Health (semFYC), Almería, Spain
                [9 ]Belén Health Centre, Jaén, Spain
                [10 ]Family and Community Medicine Teaching Unit of Jaén, Jaén, Spain
                [11 ]Mediterranean Health Centre, Torrecárdenas, Almería, Spain
                [12 ]Familiar and Community Attention Multiprofessional Teaching Unit of León II, Ponferrada, León, Spain
                [13 ]ISNI 0000 0001 2152 8769, GRID grid.11205.37, Department of Psychology and Sociology, , University of Zaragoza, ; Zaragoza, Spain
                [14 ]ISNI 0000 0004 1936 9166, GRID grid.412750.5, University of Rochester Medical Center, ; New York, USA
                [15 ]Family and Community Medicine Teaching Unit of Burgos, Burgos, Spain
                [16 ]Family and Community Medicine Teaching Unit of Córdoba. Lucena II Health Centre, Córdoba, Spain
                Author information
                http://orcid.org/0000-0002-8784-4905
                Article
                Publisher ID: 913
                DOI: 10.1186/s12875-019-0913-z
                PMC ID: 6364464
                PubMed ID: 30727962
                SO-VID: af3cfde5-97ab-4776-b90c-ff890acc9a46
                Copyright © © The Author(s). 2019
                License:

                Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                Date received : 21 September 2018
                Date accepted : 25 January 2019
                Funding
                Funded by: Sociedad Andaluza de Medicina Familiar y Comunitaria
                Award ID: Isabel Fernández, 2017
                Categories
                Subject: Study Protocol
                Custom metadata
                issue-copyright-statement © The Author(s) 2019

                ScienceOpen disciplines: Medicine
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                ScienceOpen disciplines: Medicine

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