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

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ClinicalTrials.gov Identifier: NCT02897284
Recruitment Status : Completed
First Posted : September 13, 2016
Last Update Posted : September 13, 2016
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by (Responsible Party):
Marcelo Marcos Piva Demarzo, Centro Mente Aberta de Mindfulness

Tracking Information
First Submitted Date  ICMJE August 10, 2016
First Posted Date  ICMJE September 13, 2016
Last Update Posted Date September 13, 2016
Study Start Date  ICMJE May 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 7, 2016)
  • A mindfulness intervention decreases Burnout [ Time Frame: up to 2 months of follow-up ]
    Evaluation of Burnout symptoms through the MBI-GS scale
  • A mindfulness intervention increases Happiness [ Time Frame: up to 2 months of follow-up ]
    Evaluation of Happiness levels through the PHI (Pemberton) scale
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 7, 2016)
  • A mindfulness intervention increases Mindfulness [ Time Frame: up to 2 months of follow-up ]
    Evaluation of Mindfulness levels through the MAAS scale
  • A mindfulness intervention improves Epigenetic [ Time Frame: up to 2 months of follow-up ]
    Evaluation of epigenetic-related activity through Homocysteine levels (Pfeiffer, 1999)
  • 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)
  • 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)
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Mindfulness for Burnout Prevention in Primary Care Providers
Official Title  ICMJE Evaluation of Mindfulness-based Self-care Programs for the Prevention of Burnout Among Primary Care Providers: Psychological, Inflammatory and Epigenetic Effects
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Burnout, Professional
Intervention  ICMJE
  • Behavioral: Mindfulness 8 weeks
    8 sessions of mindfulness
  • Behavioral: Mindfulness 2 weeks
    2 sessions of mindfulness
Study Arms  ICMJE
  • Experimental: Mindfulness 8 weeks
    Mindfulness-based intervention with 8 weekly sessions
    Intervention: Behavioral: Mindfulness 8 weeks
  • Active Comparator: Mindfulness 2 weeks
    Mindfulness-based intervention with 2 weekly sessions
    Intervention: Behavioral: Mindfulness 2 weeks
  • No Intervention: Control
    waiting list
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 7, 2016)
400
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02897284
Other Study ID Numbers  ICMJE CMAMindfulness
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Marcelo Marcos Piva Demarzo, Centro Mente Aberta de Mindfulness
Study Sponsor  ICMJE Centro Mente Aberta de Mindfulness
Collaborators  ICMJE Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators  ICMJE
Principal Investigator: Marcelo MP Demarzo, MD, PhD Mente Aberta - Brazilian Center for Mindfulness and Health Promotion
PRS Account Centro Mente Aberta de Mindfulness
Verification Date September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP