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

Primary Purpose

Stress, Cognitive Impairment, Burnout Syndrome

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
MBHP-Educa
Sponsored by
Marcelo Demarzo, MD, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stress

Eligibility Criteria

23 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Centro Mente Aberta de Mindfulness e Promoção de Saúde

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MBHP-Educa

Control Group

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

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
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
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)

Secondary Outcome Measures

Glutathione metabolism from blood samples
GSH plasma levels, Cysteine and homocisteine serum levels
Perceived Stress Scale (PSS-10)
to evaluate the level of subjectively noticed stress, composed of 10 items
Determination of cytokine levels in serum samples.
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)
Connor-Davidson Resilience Rating Scale
The CD-RISC is a 25-item measure of resilience.
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

Full Information

First Posted
October 15, 2018
Last Updated
March 1, 2021
Sponsor
Marcelo Demarzo, MD, PhD
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1. Study Identification

Unique Protocol Identification Number
NCT03839030
Brief Title
Mindfulness-Based Health Promotion Program for Educators (MBHP - Educa).
Acronym
Mindfulness
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

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
March 5, 2018 (Actual)
Primary Completion Date
July 5, 2019 (Actual)
Study Completion Date
July 5, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Marcelo Demarzo, MD, PhD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Cognitive Impairment, Burnout Syndrome

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
146 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MBHP-Educa
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
MBHP-Educa
Intervention Description
This intervention is a meditative practice which the individuals will practice in their daily life following the MBHP-educa protocol
Primary Outcome Measure Information:
Title
World Health Organization Quality of Life-BREF (WHOQOL-BREF)
Description
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
Time Frame
Pre-test, Post-test and follow-up (12 months)
Title
Pittsburgh Sleep Quality Index
Description
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
Time Frame
Pre-test, Post-test and follow-up (12 months)
Title
Morningness-eveningness questionnaire - sum *Range 16 to 86 *higher scorer - more morningness type
Description
To evaluate person's circadian rhythm (biological clock) (sum of all responses)
Time Frame
Pre-test, Post-test and follow-up (12 months)
Secondary Outcome Measure Information:
Title
Glutathione metabolism from blood samples
Description
GSH plasma levels, Cysteine and homocisteine serum levels
Time Frame
Pre-test, Post-test and follow-up (12 months)
Title
Perceived Stress Scale (PSS-10)
Description
to evaluate the level of subjectively noticed stress, composed of 10 items
Time Frame
Pre-test, Post-test and follow-up (12 months)
Title
Determination of cytokine levels in serum samples.
Description
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)
Time Frame
Pre-test, Post-test and follow-up (12 months)
Title
Connor-Davidson Resilience Rating Scale
Description
The CD-RISC is a 25-item measure of resilience.
Time Frame
Pre-test, Post-test and follow-up (12 months)
Title
Positive and Negative Affect Schedule (PANAS)
Description
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
Time Frame
Pre-test, Post-test and follow-up (12 months)
Other Pre-specified Outcome Measures:
Title
Five Facet Mindfulness Questionnaire (FFMQ)
Description
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
Time Frame
Pre-test, Post-test and follow-up (12 months)
Title
Rey Auditory-Verbal Learning Test - RAVLT
Description
To evaluate memory (number of word remember)
Time Frame
Pre-test, Post-test and follow-up (12 months)
Title
Stroop test
Description
To evaluate attention and inhibitory behavior (number of errors and time)
Time Frame
Pre-test, Post-test and follow-up (12 months)
Title
Digit span test
Description
To evaluate work memory (maximum lenght)
Time Frame
Pre-test, Post-test and follow-up (12 months)
Title
Trail Making Test - TMT
Description
To evaluate attention (time to trail every letter or/and number)
Time Frame
Pre-test, Post-test and follow-up (12 months)
Title
Hospital Anxiety and Depression Scale (HAADS)
Description
To evaluate anxiety and depression symptoms through two subscales: anxiety - sum depression - sum each question range zero to four higher score - more symptons
Time Frame
Pre-test, Post-test and follow-up (12 months)
Title
Burnout Clinical Subtypes Questionnaire - BCSQ-12
Description
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
Time Frame
Pre-test, Post-test and follow-up (12 months)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcelo MP Demarzo, PhD
Organizational Affiliation
Federal University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centro Mente Aberta de Mindfulness e Promoção de Saúde
City
São Paulo
State/Province
SP
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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