Clinical Trial: Mindfulness for Burnout Prevention in Primary Care Providers

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Evaluation of Mindfulness-based Self-care Programs for the Prevention of Burnout Among Primary Care Providers: Psychological, Inflammatory and Epigenetic Effects

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.

Detailed Summary: 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.
Sponsor: Centro Mente Aberta de Mindfulness

Current Primary Outcome:

  • A mindfulness intervention decreases Burnout [ Time Frame: up to 2 months of follow-up ]
    Evaluation of Burnout symptoms through the MBI-GS scale
  • A mindfulness intervention increases Happiness [ Time Frame: up to 2 months of follow-up ]
    Evaluation of Happiness levels through the PHI (Pemberton) scale


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: Centro Mente Aberta de Mindfulness

Dates:
Date Received: August 10, 2016
Date Started: May 2015
Date Completion:
Last Updated: September 7, 2016
Last Verified: September 2016