Clinical trial NCT03839030: Mindfulness-Based Health Promotion Program for Educators (MBHP - Educa).
Official title: Development and Implementation of Mindfulness-Based Health Promotion Program for Educators (MBHP - Educa): Evaluation of Cognitive Functions and Epigenetic Modifications.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Cognitive Impairment
Burnout Syndrome
Lead sponsor: Centro Mente Aberta de Mindfulness
Sponsor class: OTHER
First posted: 2019-02-12
Enrollment: 146
Sex: FEMALE
Minimum age (years): 23
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: World Health Organization Quality of Life-BREF (WHOQOL-BREF)
timeFrame: Pre-test, Post-test and follow-up (12 months)
measure: Pittsburgh Sleep Quality Index
timeFrame: Pre-test, Post-test and follow-up (12 months)
measure: Morningness-eveningness questionnaire - sum *Range 16 to 86 *higher scorer - more morningness type
timeFrame: Pre-test, Post-test and follow-up (12 months)
Secondary outcomes:
measure: Glutathione metabolism from blood samples
timeFrame: Pre-test, Post-test and follow-up (12 months)
measure: Perceived Stress Scale (PSS-10)
timeFrame: Pre-test, Post-test and follow-up (12 months)
measure: Determination of cytokine levels in serum samples.
timeFrame: Pre-test, Post-test and follow-up (12 months)
measure: Connor-Davidson Resilience Rating Scale
timeFrame: Pre-test, Post-test and follow-up (12 months)
measure: Positive and Negative Affect Schedule (PANAS)
timeFrame: Pre-test, Post-test and follow-up (12 months)
Other outcomes:
measure: Five Facet Mindfulness Questionnaire (FFMQ)
timeFrame: Pre-test, Post-test and follow-up (12 months)
measure: Rey Auditory-Verbal Learning Test - RAVLT
timeFrame: Pre-test, Post-test and follow-up (12 months)
measure: Stroop test
timeFrame: Pre-test, Post-test and follow-up (12 months)
measure: Digit span test
timeFrame: Pre-test, Post-test and follow-up (12 months)
measure: Trail Making Test - TMT
timeFrame: Pre-test, Post-test and follow-up (12 months)
measure: Hospital Anxiety and Depression Scale (HAADS)
timeFrame: Pre-test, Post-test and follow-up (12 months)
measure: Burnout Clinical Subtypes Questionnaire - BCSQ-12
timeFrame: Pre-test, Post-test and follow-up (12 months)
Locations:
city: São Paulo
country: Brazil
facility: Centro Mente Aberta de Mindfulness e Promoção de Saúde
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Marcelo MP Demarzo, PhD
role: PRINCIPAL_INVESTIGATOR
References: