NCT02897284

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 10, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 13, 2016

Completed
Last Updated

September 13, 2016

Status Verified

September 1, 2016

Enrollment Period

7 months

First QC Date

August 10, 2016

Last Update Submit

September 7, 2016

Conditions

Keywords

Mindfulness-basedSelf-careHealth workersEpigenetics

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (5)

  • A mindfulness intervention increases Mindfulness

    up to 2 months of follow-up

  • A mindfulness intervention improves Epigenetic

    up to 2 months of follow-up

  • A mindfulness intervention improves Epigenetic (II)

    up to 2 months of follow-up

  • A mindfulness intervention improves Epigenetic (III)

    up to 2 months of follow-up

  • A mindfulness intervention improves Inflammation

    up to 2 months of follow-up

Study Arms (3)

Mindfulness 8 weeks

EXPERIMENTAL

Mindfulness-based intervention with 8 weekly sessions

Behavioral: Mindfulness 8 weeks

Mindfulness 2 weeks

ACTIVE COMPARATOR

Mindfulness-based intervention with 2 weekly sessions

Behavioral: Mindfulness 2 weeks

Control

NO INTERVENTION

waiting list

Interventions

8 sessions of mindfulness

Mindfulness 8 weeks

2 sessions of mindfulness

Mindfulness 2 weeks

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Active Primary Care Providers

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (39)

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    BACKGROUND
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    PMID: 19341981BACKGROUND
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    PMID: 20129713BACKGROUND
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    PMID: 21802619BACKGROUND
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    PMID: 21457899BACKGROUND
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    PMID: 22614170BACKGROUND
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    PMID: 23721869BACKGROUND
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    PMID: 19699996BACKGROUND
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    PMID: 22621147BACKGROUND
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    PMID: 19913756BACKGROUND
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    PMID: 23110723BACKGROUND
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    PMID: 20525178BACKGROUND
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    PMID: 19578577BACKGROUND
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    BACKGROUND
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    BACKGROUND
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    BACKGROUND
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    BACKGROUND
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    BACKGROUND
  • Tucunduva LT, Garcia AP, Prudente FV, Centofanti G, de Souza CM, Monteiro TA, Vince FA, Samano ES, Goncalves MS, Del Giglio A. [Incidence of the burnout syndrome among Brazilian cancer physicians]. Rev Assoc Med Bras (1992). 2006 Mar-Apr;52(2):108-12. doi: 10.1590/s0104-42302006000200021. Epub 2006 Jun 1. Portuguese.

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MeSH Terms

Conditions

Burnout, Professional

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Occupational StressOccupational DiseasesBurnout, PsychologicalStress, PsychologicalBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Marcelo MP Demarzo, MD, PhD

    Mente Aberta - Brazilian Center for Mindfulness and Health Promotion

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor at Preventive Medicine Dept. - Unifesp

Study Record Dates

First Submitted

August 10, 2016

First Posted

September 13, 2016

Study Start

May 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

September 13, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share