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Clinical Trials/NCT02897284
NCT02897284
Completed
Not Applicable

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

Centro Mente Aberta de Mindfulness0 sites400 target enrollmentMay 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Burnout, Professional
Sponsor
Centro Mente Aberta de Mindfulness
Enrollment
400
Primary Endpoint
A mindfulness intervention decreases Burnout
Status
Completed
Last Updated
9 years ago

Overview

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 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.

Registry
clinicaltrials.gov
Start Date
May 2015
End Date
December 2015
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Centro Mente Aberta de Mindfulness
Responsible Party
Principal Investigator
Principal Investigator

Marcelo Marcos Piva Demarzo

Professor at Preventive Medicine Dept. - Unifesp

Centro Mente Aberta de Mindfulness

Eligibility 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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • A mindfulness intervention increases Mindfulness(up to 2 months of follow-up)
  • A mindfulness intervention improves Epigenetic(up to 2 months of follow-up)
  • A mindfulness intervention improves Epigenetic (II)(up to 2 months of follow-up)
  • A mindfulness intervention improves Epigenetic (III)(up to 2 months of follow-up)
  • A mindfulness intervention improves Inflammation(up to 2 months of follow-up)

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