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临床试验/NCT02897284
NCT02897284已完成不适用

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 个研究点目标入组 400 人开始时间: 2015年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
400
主要终点
A mindfulness intervention decreases Burnout

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Active Primary Care Providers

排除标准

  • 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.

结局指标

主要结局

A mindfulness intervention decreases Burnout

时间窗: up to 2 months of follow-up

Evaluation of Burnout symptoms through the MBI-GS scale

A mindfulness intervention increases Happiness

时间窗: up to 2 months of follow-up

Evaluation of Happiness levels through the PHI (Pemberton) scale

次要结局

  • 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)

研究者

发起方
Centro Mente Aberta de Mindfulness
申办方类型
Other
责任方
Principal Investigator
主要研究者

Marcelo Marcos Piva Demarzo

Professor at Preventive Medicine Dept. - Unifesp

Centro Mente Aberta de Mindfulness

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