Clinical trial NCT02897284: Mindfulness for Burnout Prevention in Primary Care Providers
Official title: Evaluation of Mindfulness-based Self-care Programs for the Prevention of Burnout Among Primary Care Providers: Psychological, Inflammatory and Epigenetic Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burnout, Professional
Keywords: Mindfulness-based
Self-care
Health workers
Epigenetics
Lead sponsor: Centro Mente Aberta de Mindfulness
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2016-09-13
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: A mindfulness intervention decreases Burnout
timeFrame: up to 2 months of follow-up
measure: A mindfulness intervention increases Happiness
timeFrame: up to 2 months of follow-up
Secondary outcomes:
measure: A mindfulness intervention increases Mindfulness
timeFrame: up to 2 months of follow-up
measure: A mindfulness intervention improves Epigenetic
timeFrame: up to 2 months of follow-up
measure: A mindfulness intervention improves Epigenetic (II)
timeFrame: up to 2 months of follow-up
measure: A mindfulness intervention improves Epigenetic (III)
timeFrame: up to 2 months of follow-up
measure: A mindfulness intervention improves Inflammation
timeFrame: up to 2 months of follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Mente Aberta - Brazilian Center for Mindfulness and Health Promotion
name: Marcelo MP Demarzo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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