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Mindfulness for Burnout Prevention in Primary Care Providers (Mind-Care)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02897284
Recruitment Status : Completed
First Posted : September 13, 2016
Last Update Posted : September 13, 2016
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Marcelo Marcos Piva Demarzo, Centro Mente Aberta de Mindfulness

Brief Summary:
Burnout Syndrome is one of the major challenges for health systems worldwide. This study strives to evaluate the feasibility and effectiveness of an 8- versus 2-week mindfulness-based self-care program on burnout symptoms and psychological and biological variables.

Condition or disease Intervention/treatment Phase
Burnout, Professional Behavioral: Mindfulness 8 weeks Behavioral: Mindfulness 2 weeks Not Applicable

Detailed Description:
The development of stepped-care interventions allows for the development of new strategies within mindfulness-based approaches, classically described as a weekly two-hour commitment which lasts eight weeks. Such approaches might reach larger and stratified groups, more suitable for usage in Brazilian health-system context. For such evaluations, the investigators will use a 3-arms randomized clinical trial design, with Sociodemographic and Labor variables, such as age, sex, number of offspring, adherence to the program, adherence to the mindfulness practices, Burnout Clinical Subtype Questionnaire -(BCSQ-36), Maslach Burnout Inventory (MBI-GS), Mindfulness Attention Awareness Scale (MAAS), Freiburg Mindfulness Inventory adapted for Brazil (FMI-Br-13), Five-Facet Mindfulness Questionnaire (FFMQ-Br). DNA methylation will be measured by Methylase-reaction, and BDNF (brain-derived neurotrophic factor) will be quantified by ELISA-sandwich. The primary outcome will be the effectiveness of such programs on different clinical subtypes of Burnout symptoms (frenetic, under challenged and worn-out). The secondary outcome will be mindfulness levels, and adherence to the program and to the mindfulness practice, and on inflammation and epigenetic variables.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Evaluation of Mindfulness-based Self-care Programs for the Prevention of Burnout Among Primary Care Providers: Psychological, Inflammatory and Epigenetic Effects
Study Start Date : May 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Arm Intervention/treatment
Experimental: Mindfulness 8 weeks
Mindfulness-based intervention with 8 weekly sessions
Behavioral: Mindfulness 8 weeks
8 sessions of mindfulness

Active Comparator: Mindfulness 2 weeks
Mindfulness-based intervention with 2 weekly sessions
Behavioral: Mindfulness 2 weeks
2 sessions of mindfulness

No Intervention: Control
waiting list



Primary Outcome Measures :
  1. A mindfulness intervention decreases Burnout [ Time Frame: up to 2 months of follow-up ]
    Evaluation of Burnout symptoms through the MBI-GS scale

  2. A mindfulness intervention increases Happiness [ Time Frame: up to 2 months of follow-up ]
    Evaluation of Happiness levels through the PHI (Pemberton) scale


Secondary Outcome Measures :
  1. A mindfulness intervention increases Mindfulness [ Time Frame: up to 2 months of follow-up ]
    Evaluation of Mindfulness levels through the MAAS scale

  2. A mindfulness intervention improves Epigenetic [ Time Frame: up to 2 months of follow-up ]
    Evaluation of epigenetic-related activity through Homocysteine levels (Pfeiffer, 1999)

  3. A mindfulness intervention improves Epigenetic (II) [ Time Frame: up to 2 months of follow-up ]
    Evaluation of epigenetic-related activity through Cysteine levels (Pfeiffer, 1999)

  4. A mindfulness intervention improves Epigenetic (III) [ Time Frame: up to 2 months of follow-up ]
    Evaluation of epigenetic-related activity through Methylase Reaction (Radiomarking of methyl groups)

  5. A mindfulness intervention improves Inflammation [ Time Frame: up to 2 months of follow-up ]
    Evaluation of inflammation-related activity through seric Brain-Derived Neurotrophic Factor - BDNF- (ELISA-Sandwich)



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Active Primary Care Providers

Exclusion Criteria:

  • Acute disease (physical or mental)
  • Schizophrenia or other psychotic symptoms
  • Concomitant use of medication causing attentional, cognitive or concentration impairments
  • Having practiced mindfulness or other contemplative techniques in the previous 12 months of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02897284


Sponsors and Collaborators
Centro Mente Aberta de Mindfulness
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
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Principal Investigator: Marcelo MP Demarzo, MD, PhD Mente Aberta - Brazilian Center for Mindfulness and Health Promotion

Publications:
Barros VV. Evidências de validade da Escala de Atenção e Consciência Plenas (MAAS) e do Questionário das Facetas de Mindfulness (FFMQ-BR) entre usuários de tabaco e população geral [dissertação]. Juiz de Fora (MG): Universidade Federal de Juiz de Fora; 2013.
Coyle D, Doherty G. Stepped care and mental health technologies, en ECCE 2010 workshop on Cognitive Engineering for Technology in Mental Health Care and Rehabilitation, pp. 99-102, 2010.
Demarzo MMP. Meditação aplicada à saúde. Programa Atualização em Med Família e Comunidade. 6th ed. Porto ALegre-RS: Artmed; 2011;6(1):1-18.
Epstein RM, Krasner MS, RM E, MS K. Physician resilience: What it means, why it matters, and how to promote it. Acad Med [Internet]. Department of Family Medicine Psychiatry, Oncology, and Nursing, Center for Communication and Disparities Research, University of Rochester Medical Center, 1381 South Ave., Rochester, NY 14620, United States; 2013;88(3):301-3. Available from: http://www.scopus.com/inward/record.url?eid=2-s2.0-84874846134&partnerID=40&md5=c18e567021a5e9f4d6743a9277122cbe
Hirayama MS. Freiburg Mindfulness Inventory: Adaptação cultural e validação para a língua portuguesa no Brasil. [tese]. Campinas (SP): Universidade estadual de Campinas, 2014.
Nakamura E. O Método Etnográfico em Pesquisas na Área da Saúde: uma reflexão antropológica Saúde Soc. São Paulo, v.20, n.1, p.95-103, 2011
Nunes DFS, de Souza WL, do Prado AF, Demarzo MMP. Designing an ubiquitous computing environment for monitoring physical activity. 2012 25th IEEE International Symposium on Computer-Based Medical Systems (CBMS) [Internet]. IEEE; 2012 [cited 2013 Aug 10]. p. 1-6. Available from: http://ieeexplore.ieee.org/lpdocs/epic03/wrapper.htm?arnumber=6266383
Queiroz DT, Vall J, Souza AMA, Vieira NFC. Observação participante na pesquisa qualitativa: conceitos e aplicações na área da saúde. R Enferm UERJ,15(2):276-83, 2007.
Silva ATC da, Menezes PR. Esgotamento profissional e transtornos mentais comuns em agentes comunitários de saúde. Rev Saude Publica [Internet]. Faculdade de Saúde Pública da Universidade de São Paulo; 2008 Oct [cited 2013 Aug 9];42(5):921-9. Available from: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0034-89102008000500019&lng=en&nrm=iso&tlng=pt
Trigo TR, Teng CT, Hallak JEC. Síndrome de burnout ou estafa profissional e os transtornos psiquiátricos. Rev Psiquiatr Clínica [Internet]. Faculdade de Medicina da Universidade de São Paulo; 2007 [cited 2013 Aug 9];34(5):223-33. Available from: http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0101-60832007000500004&lng=pt&nrm=iso&tlng=pt

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Responsible Party: Marcelo Marcos Piva Demarzo, Professor at Preventive Medicine Dept. - Unifesp, Centro Mente Aberta de Mindfulness
ClinicalTrials.gov Identifier: NCT02897284     History of Changes
Other Study ID Numbers: CMAMindfulness
First Posted: September 13, 2016    Key Record Dates
Last Update Posted: September 13, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Marcelo Marcos Piva Demarzo, Centro Mente Aberta de Mindfulness:
Mindfulness-based
Self-care
Health workers
Epigenetics

Additional relevant MeSH terms:
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Burnout, Psychological
Burnout, Professional
Stress, Psychological
Behavioral Symptoms
Occupational Stress
Occupational Diseases