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

Primary Purpose

Burnout, Professional

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mindfulness 8 weeks
Mindfulness 2 weeks
Sponsored by
Centro Mente Aberta de Mindfulness
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Burnout, Professional focused on measuring Mindfulness-based, Self-care, Health workers, Epigenetics

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    No Intervention

    Arm Label

    Mindfulness 8 weeks

    Mindfulness 2 weeks

    Control

    Arm Description

    Mindfulness-based intervention with 8 weekly sessions

    Mindfulness-based intervention with 2 weekly sessions

    waiting list

    Outcomes

    Primary Outcome Measures

    A mindfulness intervention decreases Burnout
    Evaluation of Burnout symptoms through the MBI-GS scale
    A mindfulness intervention increases Happiness
    Evaluation of Happiness levels through the PHI (Pemberton) scale

    Secondary Outcome Measures

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

    Full Information

    First Posted
    August 10, 2016
    Last Updated
    September 7, 2016
    Sponsor
    Centro Mente Aberta de Mindfulness
    Collaborators
    Conselho Nacional de Desenvolvimento Científico e Tecnológico
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02897284
    Brief Title
    Mindfulness for Burnout Prevention in Primary Care Providers
    Acronym
    Mind-Care
    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

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    May 2015 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    December 2015 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Centro Mente Aberta de Mindfulness
    Collaborators
    Conselho Nacional de Desenvolvimento Científico e Tecnológico

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Burnout, Professional
    Keywords
    Mindfulness-based, Self-care, Health workers, Epigenetics

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    400 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Mindfulness 8 weeks
    Arm Type
    Experimental
    Arm Description
    Mindfulness-based intervention with 8 weekly sessions
    Arm Title
    Mindfulness 2 weeks
    Arm Type
    Active Comparator
    Arm Description
    Mindfulness-based intervention with 2 weekly sessions
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    waiting list
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mindfulness 8 weeks
    Intervention Description
    8 sessions of mindfulness
    Intervention Type
    Behavioral
    Intervention Name(s)
    Mindfulness 2 weeks
    Intervention Description
    2 sessions of mindfulness
    Primary Outcome Measure Information:
    Title
    A mindfulness intervention decreases Burnout
    Description
    Evaluation of Burnout symptoms through the MBI-GS scale
    Time Frame
    up to 2 months of follow-up
    Title
    A mindfulness intervention increases Happiness
    Description
    Evaluation of Happiness levels through the PHI (Pemberton) scale
    Time Frame
    up to 2 months of follow-up
    Secondary Outcome Measure Information:
    Title
    A mindfulness intervention increases Mindfulness
    Description
    Evaluation of Mindfulness levels through the MAAS scale
    Time Frame
    up to 2 months of follow-up
    Title
    A mindfulness intervention improves Epigenetic
    Description
    Evaluation of epigenetic-related activity through Homocysteine levels (Pfeiffer, 1999)
    Time Frame
    up to 2 months of follow-up
    Title
    A mindfulness intervention improves Epigenetic (II)
    Description
    Evaluation of epigenetic-related activity through Cysteine levels (Pfeiffer, 1999)
    Time Frame
    up to 2 months of follow-up
    Title
    A mindfulness intervention improves Epigenetic (III)
    Description
    Evaluation of epigenetic-related activity through Methylase Reaction (Radiomarking of methyl groups)
    Time Frame
    up to 2 months of follow-up
    Title
    A mindfulness intervention improves Inflammation
    Description
    Evaluation of inflammation-related activity through seric Brain-Derived Neurotrophic Factor - BDNF- (ELISA-Sandwich)
    Time Frame
    up to 2 months of follow-up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Marcelo MP Demarzo, MD, PhD
    Organizational Affiliation
    Mente Aberta - Brazilian Center for Mindfulness and Health Promotion
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
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