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OpenTrials
Completed

NCT Number: NCT02897284

Mindfulness for Burnout Prevention in Primary Care Providers

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness 8 weeks

Behavioral

8 sessions of mindfulness

Mindfulness 2 weeks

Behavioral

2 sessions of mindfulness

Primary outcomes

  1. A mindfulness intervention decreases Burnout

    Time frame: up to 2 months of follow-up

    Evaluation of Burnout symptoms through the MBI-GS scale

  2. A mindfulness intervention increases Happiness

    Time frame: up to 2 months of follow-up

    Evaluation of Happiness levels through the PHI (Pemberton) scale

Secondary outcomes

  1. A mindfulness intervention increases Mindfulness

    Time frame: up to 2 months of follow-up

    Evaluation of Mindfulness levels through the MAAS scale

  2. A mindfulness intervention improves Epigenetic

    Time frame: up to 2 months of follow-up

    Evaluation of epigenetic-related activity through Homocysteine levels (Pfeiffer, 1999)

  3. 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)

  4. 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)

  5. 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)

Sponsors and collaborators

Lead sponsor

Centro Mente Aberta de Mindfulness

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

Registry information

Official study title

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

Acronym: Mind-Care

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Sep 13, 2016
Registry last updated
Sep 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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