StressMindfulnessNCT03839030
Mindfulness-Based Health Promotion Program for Educators (MBHP - Educa).
A study testing MBHP-Educa in people with Stress and Cognitive Impairment, run by Marcelo Demarzo, MD, PhD at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 23 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress, Cognitive Impairment, Burnout Syndrome
- What is being tested?
- MBHP-Educa
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteBrazil
- Study dates
- 5 Mar 2018to 5 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 23 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1)Brazilian male or female aged between 23 and 65 years and (2) currently working in the classroom
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Centro Mente Aberta de Mindfulness e Promoção de Saúde
São Paulo, São Paulo
About this study
Official title: Development and Implementation of Mindfulness-Based Health Promotion Program for Educators (MBHP - Educa): Evaluation of Cognitive Functions and Epigenetic Modifications.
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.
Read the 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.
- Conditions
- Stress, Cognitive Impairment, Burnout Syndrome
- Being tested
- MBHP-Educa
- Medical subject headings
- Cognitive Dysfunction, Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MBHP-EducaOther
This intervention is a meditative practice which the individuals will practice in their daily life following the MBHP-educa protocol
| Study group | Role | What they receive |
|---|---|---|
| MBHP-Educa | Experimental | 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. Receives: Other: MBHP-Educa |
| Control Group | No intervention | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Pre-test, Post-test and follow-up (12 months)
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
Measured: Pre-test, Post-test and follow-up (12 months)
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)
Measured: Pre-test, Post-test and follow-up (12 months)
Secondary outcomes (5)
Glutathione metabolism from blood samples
GSH plasma levels, Cysteine and homocisteine serum levels
Measured: Pre-test, Post-test and follow-up (12 months)
Perceived Stress Scale (PSS-10)
to evaluate the level of subjectively noticed stress, composed of 10 items
Measured: Pre-test, Post-test and follow-up (12 months)
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)
Measured: Pre-test, Post-test and follow-up (12 months)
Connor-Davidson Resilience Rating Scale
The CD-RISC is a 25-item measure of resilience.
Measured: Pre-test, Post-test and follow-up (12 months)
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
Measured: Pre-test, Post-test and follow-up (12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2019
- Study start5 Mar 2018
- Primary completion5 Jul 2019
- Study completion5 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marcelo Demarzo, MD, PhD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Marcelo Demarzo, MD, PhD, Centro Mente Aberta de Mindfulness
- Investigators
- Marcelo MP Demarzo, PhD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03839030
- Sponsor's protocol ID
- 92876418.2.0000.5505
- Acronym
- Mindfulness
- Status last verified
- Mar 2021
- First submitted
- 15 Oct 2018
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Implementation of Mindfulness-Based Health Promotion Program for Educators (MBHP - Educa): Evaluation of Cognitive Functions and Epigenetic Modifications.
- ClinicalTrials.gov ID
- NCT03839030
- Acronym / sponsor ID
- Mindfulness / 92876418.2.0000.5505
- Conditions
- Stress, Cognitive Impairment, Burnout Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Marcelo Demarzo, MD, PhDUniversity, hospital or other
- Study start
- 5 Mar 2018 (actual)
- Primary completion
- 5 Jul 2019 (actual)
- Study completion
- 5 Jul 2020 (actual)
- First posted
- 12 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBHP-Educa | Experimental | Other: MBHP-EducaExperimental: 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 | No intervention | –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). |
Who may qualify
- Ages
- 23 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1)Brazilian male or female aged between 23 and 65 years and (2) currently working in the classroom
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MBHP-EducaThis intervention is a meditative practice which the individuals will practice in their daily life following the MBHP-educa protocol | Other | MBHP-Educa |
Primary outcome
World Health Organization Quality of Life-BREF (WHOQOL-BREF)
Time frame: Pre-test, Post-test and follow-up (12 months)
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
Time frame: Pre-test, Post-test and follow-up (12 months)
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
Time frame: Pre-test, Post-test and follow-up (12 months)
To evaluate person's circadian rhythm (biological clock) (sum of all responses)
5 secondary outcomes
Glutathione metabolism from blood samples
Time frame: Pre-test, Post-test and follow-up (12 months)
Perceived Stress Scale (PSS-10)
Time frame: Pre-test, Post-test and follow-up (12 months)
Determination of cytokine levels in serum samples.
Time frame: Pre-test, Post-test and follow-up (12 months)
Connor-Davidson Resilience Rating Scale
Time frame: Pre-test, Post-test and follow-up (12 months)
Positive and Negative Affect Schedule (PANAS)
Time frame: Pre-test, Post-test and follow-up (12 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcelo MP Demarzo, PhD principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MBHP-Educa in people with Stress and Cognitive Impairment, run by Marcelo Demarzo, MD, PhD at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
World Health Organization Quality of Life-BREF (WHOQOL-BREF) (time frame: Pre-test, Post-test and follow-up (12 months)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2021.