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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03839030
Other study ID # 92876418.2.0000.5505
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 5, 2018
Est. completion date July 5, 2020

Study information

Verified date March 2021
Source Centro Mente Aberta de Mindfulness
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 146
Est. completion date July 5, 2020
Est. primary completion date July 5, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 23 Years to 65 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
Brazil Centro Mente Aberta de Mindfulness e Promoção de Saúde São Paulo SP

Sponsors (1)

Lead Sponsor Collaborator
Marcelo Demarzo, MD, PhD

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Other Five Facet Mindfulness Questionnaire (FFMQ) 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)
Other Rey Auditory-Verbal Learning Test - RAVLT To evaluate memory (number of word remember) Pre-test, Post-test and follow-up (12 months)
Other Stroop test To evaluate attention and inhibitory behavior (number of errors and time) Pre-test, Post-test and follow-up (12 months)
Other Digit span test To evaluate work memory (maximum lenght) Pre-test, Post-test and follow-up (12 months)
Other Trail Making Test - TMT To evaluate attention (time to trail every letter or/and number) Pre-test, Post-test and follow-up (12 months)
Other Hospital Anxiety and Depression Scale (HAADS) 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)
Other Burnout Clinical Subtypes Questionnaire - BCSQ-12 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)
Primary World Health Organization Quality of Life-BREF (WHOQOL-BREF) 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)
Primary Pittsburgh Sleep Quality Index 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)
Primary Morningness-eveningness questionnaire - sum *Range 16 to 86 *higher scorer - more morningness type To evaluate person's circadian rhythm (biological clock) (sum of all responses) Pre-test, Post-test and follow-up (12 months)
Secondary Glutathione metabolism from blood samples GSH plasma levels, Cysteine and homocisteine serum levels Pre-test, Post-test and follow-up (12 months)
Secondary Perceived Stress Scale (PSS-10) to evaluate the level of subjectively noticed stress, composed of 10 items Pre-test, Post-test and follow-up (12 months)
Secondary Determination of cytokine levels in serum samples. To evaluate the interleukin-8 (IL-8), interleukin-1ß (IL-1ß), 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)
Secondary Connor-Davidson Resilience Rating Scale The CD-RISC is a 25-item measure of resilience. Pre-test, Post-test and follow-up (12 months)
Secondary Positive and Negative Affect Schedule (PANAS) 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)
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