Mindfulness-Based Health Promotion Program for Educators (MBHP - Educa). (Mindfulness)

March 1, 2021 updated by: Marcelo Demarzo, MD, PhD

Development and Implementation of Mindfulness-Based Health Promotion Program for Educators (MBHP - Educa): Evaluation of Cognitive Functions and Epigenetic Modifications.

In the last few decades, the world has seen a significant increase in the occurrence of occupational diseases related to Burnout Syndrome (professional exhaustion) and stress in educators. These disorders affect mental health and teaching activity. In this way, they need to develop socio-emotional skills to cope with the psychosocial stressors related to the school environment. Currently, mindfulness-based therapies have been recommended to help educators acquire emotional self-control, and to improve self-esteem, metacognition, attention, resilience and affectivity, in addition to better the social skills needed in the school milieu. The main objective of the proposed research project is to elaborate a program of Mindfulness-Based Health Promotion - educators (MBHP - educa) to be applied to a population of Brazilian public school educators. The efficacy of the program will be evaluated by cognitive testing. Blood tests for the above-mentioned stress-related molecules will be performed. The goal of developing the MBHP - educa Program is to promote and ameliorate the health care of public school teachers. Developing such a research proposal will contribute to debate and implement public health policies focussed on promoting the health of public school teachers in Brazil.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

In the last few decades, the world has seen a significant increase in the occurrence of occupational diseases related to Burnout Syndrome (professional exhaustion) and stress in educators. These disorders affect mental health and teaching activity. In this way, they need to develop socio-emotional skills to cope with the psychosocial stressors related to the school environment. Currently, mindfulness-based therapies have been recommended to help educators acquire emotional self-control, and to improve self-esteem, metacognition, attention, resilience and affectivity, in addition to better the social skills needed in the school milieu. A few published studies indicate that mindfulness practices also reduce some inflammation- and stress- related molecules such as cortisol, receptor-interacting serine/threonine kinase 2 (RIPK2), cyclooxygenase 2 (COX2), interleukin 6 (IL-6), tumor necrosis factor-α (TNF-α) and epigenetic-regulation related histone deacetilases (HDAC). These indicator molecules can be measured in blood. The World Health Organisation (WHO-2013) recommends the worldwide implementation of strategies for the promotion of mental health, which are particularly aimed at preventing occupational diseases. The main objective of the proposed research project is to elaborate a program of Mindfulness-Based Health Promotion - educators (MBHP - educa) to be applied to a population of Brazilian public school educators. The efficacy of the program will be evaluated by cognitive testing. Blood tests for the above-mentioned stress-related molecules will be performed. The goal of developing the MBHP - educa Program is to promote and ameliorate the health care of public school teachers. Developing such a research proposal will contribute to debate and implement public health policies focussed on promoting the health of public school teachers in Brazil.

Study Type

Interventional

Enrollment (Actual)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • SP
      • São Paulo, SP, Brazil
        • Centro Mente Aberta de Mindfulness e Promoção de Saúde

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

1)Brazilian male or female aged between 23 and 65 years and (2) currently working in the classroom

Exclusion Criteria:

(1) the presence of medical conditions or medications use that might affect inflammatory pathways; (2) report of an infectious condition in the last 15 days before collecting a blood sample; (3) active psychiatric and/or clinical comorbidities potentially life-threatening such as psychosis or suicidal ideation; and (4) had previously practiced or currently practicing meditation, yoga or Tai-Chi

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: MBHP-Educa
Experimental: Intervention Group A novel Mindfulness-based Health Promotion program for Educators for active teachers will be employed. The intervention will be held once a week for 8-weeks, two-hour meetings (16.0-h total). Participants will be encouraged to meditate for 10-30 min/day via audio recording.
This intervention is a meditative practice which the individuals will practice in their daily life following the MBHP-educa protocol
NO_INTERVENTION: Control Group
Control Group Teacher education as usual. These participants will participate in teacher training (Neuroscience for Education - Neuro Educa). The Neuro-Educa will be held once a week for 8-weeks, two-hour meetings (16.0-h total).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
World Health Organization Quality of Life-BREF (WHOQOL-BREF)
Time Frame: Pre-test, Post-test and follow-up (12 months)

To evaluate quality of life through five subscales:

physical domain - mean of responses psychological domain - mean of responses relationships domain - mean of responses environment domain - mean of responses quality of life and perception of life - mean of responses

*each question response range one to five points Higher scores - Better Quality of Life

Pre-test, Post-test and follow-up (12 months)
Pittsburgh Sleep Quality Index
Time Frame: Pre-test, Post-test and follow-up (12 months)

To evaluate the Sleep Quality - sum of responses score

*each questions have a specific conversion to range zero to six

Higher scores - better sleep quality

Pre-test, Post-test and follow-up (12 months)
Morningness-eveningness questionnaire - sum *Range 16 to 86 *higher scorer - more morningness type
Time Frame: Pre-test, Post-test and follow-up (12 months)
To evaluate person's circadian rhythm (biological clock) (sum of all responses)
Pre-test, Post-test and follow-up (12 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glutathione metabolism from blood samples
Time Frame: Pre-test, Post-test and follow-up (12 months)
GSH plasma levels, Cysteine and homocisteine serum levels
Pre-test, Post-test and follow-up (12 months)
Perceived Stress Scale (PSS-10)
Time Frame: Pre-test, Post-test and follow-up (12 months)
to evaluate the level of subjectively noticed stress, composed of 10 items
Pre-test, Post-test and follow-up (12 months)
Determination of cytokine levels in serum samples.
Time Frame: Pre-test, Post-test and follow-up (12 months)

To evaluate the interleukin-8 (IL-8), interleukin-1β (IL-1β), interleukin-6 (IL-6), interleukin-10 (IL-10), tumor necrosis factor (TNF) e interleukin-12p70 (IL-12p70)

*Concentration in micromol per liter. (mean and standard deviation, median and quartile per groups)

Pre-test, Post-test and follow-up (12 months)
Connor-Davidson Resilience Rating Scale
Time Frame: Pre-test, Post-test and follow-up (12 months)
The CD-RISC is a 25-item measure of resilience.
Pre-test, Post-test and follow-up (12 months)
Positive and Negative Affect Schedule (PANAS)
Time Frame: Pre-test, Post-test and follow-up (12 months)

To evaluate positive and negative Affect through two subscales:

positive affect - sum negative affect - sum

  • each question range one to five
  • higher score - more frequent
Pre-test, Post-test and follow-up (12 months)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Five Facet Mindfulness Questionnaire (FFMQ)
Time Frame: Pre-test, Post-test and follow-up (12 months)

To evaluate the mindfulness trace through five subscales:

OBSERVING - mean DESCRIBING - mean NONJUDGE - mean NONREACT - mean ATC WITH AWARENESS - mean

  • each question range one to five
  • higher score - more mindful
Pre-test, Post-test and follow-up (12 months)
Rey Auditory-Verbal Learning Test - RAVLT
Time Frame: Pre-test, Post-test and follow-up (12 months)
To evaluate memory (number of word remember)
Pre-test, Post-test and follow-up (12 months)
Stroop test
Time Frame: Pre-test, Post-test and follow-up (12 months)
To evaluate attention and inhibitory behavior (number of errors and time)
Pre-test, Post-test and follow-up (12 months)
Digit span test
Time Frame: Pre-test, Post-test and follow-up (12 months)
To evaluate work memory (maximum lenght)
Pre-test, Post-test and follow-up (12 months)
Trail Making Test - TMT
Time Frame: Pre-test, Post-test and follow-up (12 months)
To evaluate attention (time to trail every letter or/and number)
Pre-test, Post-test and follow-up (12 months)
Hospital Anxiety and Depression Scale (HAADS)
Time Frame: Pre-test, Post-test and follow-up (12 months)

To evaluate anxiety and depression symptoms through two subscales:

anxiety - sum depression - sum

  • each question range zero to four
  • higher score - more symptons
Pre-test, Post-test and follow-up (12 months)
Burnout Clinical Subtypes Questionnaire - BCSQ-12
Time Frame: Pre-test, Post-test and follow-up (12 months)

To evaluate the burnout clinical subtypes through three subscales:

Overload - mean, standard deviation and median Lack of development - mean, standard deviation and median Neglect - mean, standard deviation and median

*each question response range one to seven points

Higher scores - More Symptons of Burnout

Pre-test, Post-test and follow-up (12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 5, 2018

Primary Completion (ACTUAL)

July 5, 2019

Study Completion (ACTUAL)

July 5, 2020

Study Registration Dates

First Submitted

October 15, 2018

First Submitted That Met QC Criteria

February 10, 2019

First Posted (ACTUAL)

February 12, 2019

Study Record Updates

Last Update Posted (ACTUAL)

March 3, 2021

Last Update Submitted That Met QC Criteria

March 1, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 92876418.2.0000.5505

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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