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
About this trial
This is an interventional prevention trial for Burnout, Professional focused on measuring Mindfulness-based, Self-care, Health workers, Epigenetics
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.
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
NCT ID
NCT02897284
First Posted
August 10, 2016
Last Updated
September 7, 2016
Sponsor
Centro Mente Aberta de Mindfulness
Collaborators
Conselho Nacional de Desenvolvimento Científico e Tecnológico
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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Mindfulness for Burnout Prevention in Primary Care Providers
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