Mindfulness for Burnout Prevention in Primary Care Providers

Not Applicable

Completed

• Conditions: Burnout, Professional
• Interventions: Behavioral: Mindfulness 8 weeks; Behavioral: Mindfulness 2 weeks

• Registration Number: NCT02897284
• Lead Sponsor: Centro Mente Aberta de Mindfulness

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.

Study Timeline

• Study Start: 2015-05
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Study First Submitted: 2016-08-10
• Status Verified: 2016-09
• Study First Submitted QC: 2016-09-07
• Last Update Submitted: 2016-09-07
• Study First Posted: 2016-09-13
• Last Update Posted: 2016-09-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mindfulness 8 weeks	Mindfulness 8 weeks	Mindfulness-based intervention with 8 weekly sessions
Mindfulness 2 weeks	Mindfulness 2 weeks	Mindfulness-based intervention with 2 weekly sessions

Primary Outcome Measures

Name	Time	Method
A mindfulness intervention decreases Burnout	up to 2 months of follow-up	Evaluation of Burnout symptoms through the MBI-GS scale
A mindfulness intervention increases Happiness	up to 2 months of follow-up	Evaluation of Happiness levels through the PHI (Pemberton) scale

Secondary Outcome Measures

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