<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03839030</url>
  </required_header>
  <id_info>
    <org_study_id>92876418.2.0000.5505</org_study_id>
    <nct_id>NCT03839030</nct_id>
  </id_info>
  <brief_title>Mindfulness-Based Health Promotion Program for Educators (MBHP - Educa).</brief_title>
  <acronym>Mindfulness</acronym>
  <official_title>Development and Implementation of Mindfulness-Based Health Promotion Program for Educators (MBHP - Educa): Evaluation of Cognitive Functions and Epigenetic Modifications.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marcelo Demarzo, MD, PhD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centro Mente Aberta de Mindfulness</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the last few decades, the world has seen a significant increase in the occurrence of&#xD;
      occupational diseases related to Burnout Syndrome (professional exhaustion) and stress in&#xD;
      educators. These disorders affect mental health and teaching activity. In this way, they need&#xD;
      to develop socio-emotional skills to cope with the psychosocial stressors related to the&#xD;
      school environment. Currently, mindfulness-based therapies have been recommended to help&#xD;
      educators acquire emotional self-control, and to improve self-esteem, metacognition,&#xD;
      attention, resilience and affectivity, in addition to better the social skills needed in the&#xD;
      school milieu. The main objective of the proposed research project is to elaborate a program&#xD;
      of Mindfulness-Based Health Promotion - educators (MBHP - educa) to be applied to a&#xD;
      population of Brazilian public school educators. The efficacy of the program will be&#xD;
      evaluated by cognitive testing. Blood tests for the above-mentioned stress-related molecules&#xD;
      will be performed. The goal of developing the MBHP - educa Program is to promote and&#xD;
      ameliorate the health care of public school teachers. Developing such a research proposal&#xD;
      will contribute to debate and implement public health policies focussed on promoting the&#xD;
      health of public school teachers in Brazil.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the last few decades, the world has seen a significant increase in the occurrence of&#xD;
      occupational diseases related to Burnout Syndrome (professional exhaustion) and stress in&#xD;
      educators. These disorders affect mental health and teaching activity. In this way, they need&#xD;
      to develop socio-emotional skills to cope with the psychosocial stressors related to the&#xD;
      school environment. Currently, mindfulness-based therapies have been recommended to help&#xD;
      educators acquire emotional self-control, and to improve self-esteem, metacognition,&#xD;
      attention, resilience and affectivity, in addition to better the social skills needed in the&#xD;
      school milieu. A few published studies indicate that mindfulness practices also reduce some&#xD;
      inflammation- and stress- related molecules such as cortisol, receptor-interacting&#xD;
      serine/threonine kinase 2 (RIPK2), cyclooxygenase 2 (COX2), interleukin 6 (IL-6), tumor&#xD;
      necrosis factor-α (TNF-α) and epigenetic-regulation related histone deacetilases (HDAC).&#xD;
      These indicator molecules can be measured in blood. The World Health Organisation (WHO-2013)&#xD;
      recommends the worldwide implementation of strategies for the promotion of mental health,&#xD;
      which are particularly aimed at preventing occupational diseases. The main objective of the&#xD;
      proposed research project is to elaborate a program of Mindfulness-Based Health Promotion -&#xD;
      educators (MBHP - educa) to be applied to a population of Brazilian public school educators.&#xD;
      The efficacy of the program will be evaluated by cognitive testing. Blood tests for the&#xD;
      above-mentioned stress-related molecules will be performed. The goal of developing the MBHP -&#xD;
      educa Program is to promote and ameliorate the health care of public school teachers.&#xD;
      Developing such a research proposal will contribute to debate and implement public health&#xD;
      policies focussed on promoting the health of public school teachers in Brazil.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 5, 2018</start_date>
  <completion_date type="Actual">July 5, 2020</completion_date>
  <primary_completion_date type="Actual">July 5, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>World Health Organization Quality of Life-BREF (WHOQOL-BREF)</measure>
    <time_frame>Pre-test, Post-test and follow-up (12 months)</time_frame>
    <description>To evaluate quality of life through five subscales:&#xD;
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&#xD;
*each question response range one to five points Higher scores - Better Quality of Life</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pittsburgh Sleep Quality Index</measure>
    <time_frame>Pre-test, Post-test and follow-up (12 months)</time_frame>
    <description>To evaluate the Sleep Quality - sum of responses score&#xD;
*each questions have a specific conversion to range zero to six&#xD;
Higher scores - better sleep quality</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Morningness-eveningness questionnaire - sum *Range 16 to 86 *higher scorer - more morningness type</measure>
    <time_frame>Pre-test, Post-test and follow-up (12 months)</time_frame>
    <description>To evaluate person's circadian rhythm (biological clock) (sum of all responses)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glutathione metabolism from blood samples</measure>
    <time_frame>Pre-test, Post-test and follow-up (12 months)</time_frame>
    <description>GSH plasma levels, Cysteine and homocisteine serum levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Stress Scale (PSS-10)</measure>
    <time_frame>Pre-test, Post-test and follow-up (12 months)</time_frame>
    <description>to evaluate the level of subjectively noticed stress, composed of 10 items</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Determination of cytokine levels in serum samples.</measure>
    <time_frame>Pre-test, Post-test and follow-up (12 months)</time_frame>
    <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)&#xD;
*Concentration in micromol per liter. (mean and standard deviation, median and quartile per groups)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Connor-Davidson Resilience Rating Scale</measure>
    <time_frame>Pre-test, Post-test and follow-up (12 months)</time_frame>
    <description>The CD-RISC is a 25-item measure of resilience.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive and Negative Affect Schedule (PANAS)</measure>
    <time_frame>Pre-test, Post-test and follow-up (12 months)</time_frame>
    <description>To evaluate positive and negative Affect through two subscales:&#xD;
positive affect - sum negative affect - sum&#xD;
each question range one to five&#xD;
higher score - more frequent</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Five Facet Mindfulness Questionnaire (FFMQ)</measure>
    <time_frame>Pre-test, Post-test and follow-up (12 months)</time_frame>
    <description>To evaluate the mindfulness trace through five subscales:&#xD;
OBSERVING - mean DESCRIBING - mean NONJUDGE - mean NONREACT - mean ATC WITH AWARENESS - mean&#xD;
each question range one to five&#xD;
higher score - more mindful</description>
  </other_outcome>
  <other_outcome>
    <measure>Rey Auditory-Verbal Learning Test - RAVLT</measure>
    <time_frame>Pre-test, Post-test and follow-up (12 months)</time_frame>
    <description>To evaluate memory (number of word remember)</description>
  </other_outcome>
  <other_outcome>
    <measure>Stroop test</measure>
    <time_frame>Pre-test, Post-test and follow-up (12 months)</time_frame>
    <description>To evaluate attention and inhibitory behavior (number of errors and time)</description>
  </other_outcome>
  <other_outcome>
    <measure>Digit span test</measure>
    <time_frame>Pre-test, Post-test and follow-up (12 months)</time_frame>
    <description>To evaluate work memory (maximum lenght)</description>
  </other_outcome>
  <other_outcome>
    <measure>Trail Making Test - TMT</measure>
    <time_frame>Pre-test, Post-test and follow-up (12 months)</time_frame>
    <description>To evaluate attention (time to trail every letter or/and number)</description>
  </other_outcome>
  <other_outcome>
    <measure>Hospital Anxiety and Depression Scale (HAADS)</measure>
    <time_frame>Pre-test, Post-test and follow-up (12 months)</time_frame>
    <description>To evaluate anxiety and depression symptoms through two subscales:&#xD;
anxiety - sum depression - sum&#xD;
each question range zero to four&#xD;
higher score - more symptons</description>
  </other_outcome>
  <other_outcome>
    <measure>Burnout Clinical Subtypes Questionnaire - BCSQ-12</measure>
    <time_frame>Pre-test, Post-test and follow-up (12 months)</time_frame>
    <description>To evaluate the burnout clinical subtypes through three subscales:&#xD;
Overload - mean, standard deviation and median Lack of development - mean, standard deviation and median Neglect - mean, standard deviation and median&#xD;
*each question response range one to seven points&#xD;
Higher scores - More Symptons of Burnout</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">146</enrollment>
  <condition>Stress</condition>
  <condition>Cognitive Impairment</condition>
  <condition>Burnout Syndrome</condition>
  <arm_group>
    <arm_group_label>MBHP-Educa</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <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).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MBHP-Educa</intervention_name>
    <description>This intervention is a meditative practice which the individuals will practice in their daily life following the MBHP-educa protocol</description>
    <arm_group_label>MBHP-Educa</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1)Brazilian male or female aged between 23 and 65 years and (2) currently working in the&#xD;
        classroom&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        (1) the presence of medical conditions or medications use that might affect inflammatory&#xD;
        pathways; (2) report of an infectious condition in the last 15 days before collecting a&#xD;
        blood sample; (3) active psychiatric and/or clinical comorbidities potentially&#xD;
        life-threatening such as psychosis or suicidal ideation; and (4) had previously practiced&#xD;
        or currently practicing meditation, yoga or Tai-Chi&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>23 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marcelo MP Demarzo, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Federal University of Sao Paulo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centro Mente Aberta de Mindfulness e Promoção de Saúde</name>
      <address>
        <city>São Paulo</city>
        <state>SP</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>October 15, 2018</study_first_submitted>
  <study_first_submitted_qc>February 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <last_update_submitted>March 1, 2021</last_update_submitted>
  <last_update_submitted_qc>March 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Centro Mente Aberta de Mindfulness</investigator_affiliation>
    <investigator_full_name>Marcelo Demarzo, MD, PhD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Burnout, Psychological</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03839030
org study id: 92876418.2.0000.5505
nct id: NCT03839030
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: World Health Organization Quality of Life-BREF (WHOQOL-BREF)
time frame: Pre-test, Post-test and follow-up (12 months)
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
measure: Pittsburgh Sleep Quality Index
time frame: Pre-test, Post-test and follow-up (12 months)
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
measure: Morningness-eveningness questionnaire - sum *Range 16 to 86 *higher scorer - more morningness type
time frame: Pre-test, Post-test and follow-up (12 months)
description: To evaluate person's circadian rhythm (biological clock) (sum of all responses)
measure: Glutathione metabolism from blood samples
time frame: Pre-test, Post-test and follow-up (12 months)
description: GSH plasma levels, Cysteine and homocisteine serum levels
measure: Perceived Stress Scale (PSS-10)
time frame: Pre-test, Post-test and follow-up (12 months)
description: to evaluate the level of subjectively noticed stress, composed of 10 items
measure: Determination of cytokine levels in serum samples.
time frame: Pre-test, Post-test and follow-up (12 months)
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)
measure: Connor-Davidson Resilience Rating Scale
time frame: Pre-test, Post-test and follow-up (12 months)
description: The CD-RISC is a 25-item measure of resilience.
measure: Positive and Negative Affect Schedule (PANAS)
time frame: Pre-test, Post-test and follow-up (12 months)
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
measure: Five Facet Mindfulness Questionnaire (FFMQ)
time frame: Pre-test, Post-test and follow-up (12 months)
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
measure: Rey Auditory-Verbal Learning Test - RAVLT
time frame: Pre-test, Post-test and follow-up (12 months)
description: To evaluate memory (number of word remember)
measure: Stroop test
time frame: Pre-test, Post-test and follow-up (12 months)
description: To evaluate attention and inhibitory behavior (number of errors and time)
measure: Digit span test
time frame: Pre-test, Post-test and follow-up (12 months)
description: To evaluate work memory (maximum lenght)
measure: Trail Making Test - TMT
time frame: Pre-test, Post-test and follow-up (12 months)
description: To evaluate attention (time to trail every letter or/and number)
measure: Hospital Anxiety and Depression Scale (HAADS)
time frame: Pre-test, Post-test and follow-up (12 months)
description: To evaluate anxiety and depression symptoms through two subscales:
anxiety - sum depression - sum
each question range zero to four
higher score - more symptons
measure: Burnout Clinical Subtypes Questionnaire - BCSQ-12
time frame: Pre-test, Post-test and follow-up (12 months)
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
arm group label: MBHP-Educa
arm group type: Experimental
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 group label: Control Group
arm group type: No Intervention
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: MBHP-Educa
description: This intervention is a meditative practice which the individuals will practice in their daily life following the MBHP-educa protocol
arm group label: MBHP-Educa
criteria: 
gender: Female
minimum age: 23 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Marcelo MP Demarzo, PhD
role: Principal Investigator
affiliation: Federal University of Sao Paulo
facility: 
country: Brazil
responsible party type: Sponsor-Investigator
investigator affiliation: Centro Mente Aberta de Mindfulness
investigator full name: Marcelo Demarzo, MD, PhD
investigator title: Principal Investigator
mesh term: Burnout, Psychological
sharing ipd: Undecided