Mindfulness for Burnout Prevention in Primary Care Providers (Mind-Care)

September 7, 2016 updated by: Marcelo Marcos Piva Demarzo, Centro Mente Aberta de Mindfulness

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

400

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro Mente Aberta de Mindfulness

Collaborators

Conselho Nacional de Desenvolvimento Científico e Tecnológico

Investigators

  • Principal Investigator: Marcelo MP Demarzo, MD, PhD, Mente Aberta - Brazilian Center for Mindfulness and Health Promotion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

December 1, 2015

Study Registration Dates

First Submitted

August 10, 2016

First Submitted That Met QC Criteria

September 7, 2016

First Posted (Estimate)

September 13, 2016

Study Record Updates

Last Update Posted (Estimate)

September 13, 2016

Last Update Submitted That Met QC Criteria

September 7, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CMAMindfulness

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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