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

Stress Clinical Trial

— Mindfulness  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03839030
• Other study ID #: 92876418.2.0000.5505
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Burnout Syndrome
• Burnout, Psychological
• Cognitive Impairment
• Stress

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)