Mindfulness for Burnout Prevention in Primary Care Providers

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Burnout, Professional

Intervention / Treatment
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* Behavioral: Mindfulness 8 weeks
* Behavioral: Mindfulness 2 weeks


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness 8 weeks<br>Mindfulness-based intervention with 8 weekly sessions | Behavioral: Mindfulness 8 weeks<br>* 8 sessions of mindfulness<br>|
| Active Comparator: Mindfulness 2 weeks<br>Mindfulness-based intervention with 2 weekly sessions | Behavioral: Mindfulness 2 weeks<br>* 2 sessions of mindfulness<br>|
| No Intervention: Control<br>waiting list | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A mindfulness intervention decreases Burnout | Evaluation of Burnout symptoms through the MBI-GS scale | up to 2 months of follow-up | 
| A mindfulness intervention increases Happiness | Evaluation of Happiness levels through the PHI (Pemberton) scale | up to 2 months of follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A mindfulness intervention increases Mindfulness | Evaluation of Mindfulness levels through the MAAS scale | up to 2 months of follow-up | 
| A mindfulness intervention improves Epigenetic | Evaluation of epigenetic-related activity through Homocysteine levels (Pfeiffer, 1999) | up to 2 months of follow-up | 
| A mindfulness intervention improves Epigenetic (II) | Evaluation of epigenetic-related activity through Cysteine levels (Pfeiffer, 1999) | up to 2 months of follow-up | 
| A mindfulness intervention improves Epigenetic (III) | Evaluation of epigenetic-related activity through Methylase Reaction (Radiomarking of methyl groups) | up to 2 months of follow-up | 
| A mindfulness intervention improves Inflammation | Evaluation of inflammation-related activity through seric Brain-Derived Neurotrophic Factor - BDNF- (ELISA-Sandwich) | up to 2 months of follow-up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness-based, Self-care, Health workers, Epigenetics