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Completed

NCT Number: NCT03839030

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

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.

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Key information

Age range

23 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centro Mente Aberta de Mindfulness e Promoção de Saúde

São Paulo, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MBHP-Educa

Other

This intervention is a meditative practice which the individuals will practice in their daily life following the MBHP-educa protocol

Primary outcomes

  1. 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

  2. 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

  3. 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)

Secondary outcomes

  1. Glutathione metabolism from blood samples

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

    GSH plasma levels, Cysteine and homocisteine serum levels

  2. 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

  3. 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)

  4. 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.

  5. 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

Other outcomes

  1. 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
  2. Rey Auditory-Verbal Learning Test - RAVLT

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

    To evaluate memory (number of word remember)

  3. Stroop test

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

    To evaluate attention and inhibitory behavior (number of errors and time)

  4. Digit span test

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

    To evaluate work memory (maximum lenght)

  5. 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)

  6. 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
  7. 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

Sponsors and collaborators

Lead sponsor

Marcelo Demarzo, MD, PhD

Other

Registry information

Official study title

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

Acronym: Mindfulness

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Feb 12, 2019
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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