NCT03839030

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
146

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 5, 2018

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

October 15, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

February 12, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 5, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2020

Completed
Last Updated

March 3, 2021

Status Verified

March 1, 2021

Enrollment Period

1.3 years

First QC Date

October 15, 2018

Last Update Submit

March 1, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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)

  • 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)

  • 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 Outcomes (5)

  • Glutathione metabolism from blood samples

    Pre-test, Post-test and follow-up (12 months)

  • Perceived Stress Scale (PSS-10)

    Pre-test, Post-test and follow-up (12 months)

  • Determination of cytokine levels in serum samples.

    Pre-test, Post-test and follow-up (12 months)

  • Connor-Davidson Resilience Rating Scale

    Pre-test, Post-test and follow-up (12 months)

  • Positive and Negative Affect Schedule (PANAS)

    Pre-test, Post-test and follow-up (12 months)

Other Outcomes (7)

  • Five Facet Mindfulness Questionnaire (FFMQ)

    Pre-test, Post-test and follow-up (12 months)

  • Rey Auditory-Verbal Learning Test - RAVLT

    Pre-test, Post-test and follow-up (12 months)

  • Stroop test

    Pre-test, Post-test and follow-up (12 months)

  • +4 more other outcomes

Study Arms (2)

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.

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).

Interventions

This intervention is a meditative practice which the individuals will practice in their daily life following the MBHP-educa protocol

MBHP-Educa

Eligibility Criteria

Age23 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • )Brazilian male or female aged between 23 and 65 years and (2) currently working in the classroom

You may not qualify if:

  • (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centro Mente Aberta de Mindfulness e Promoção de Saúde

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Cognitive DysfunctionBurnout, Psychological

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Marcelo MP Demarzo, PhD

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

October 15, 2018

First Posted

February 12, 2019

Study Start

March 5, 2018

Primary Completion

July 5, 2019

Study Completion

July 5, 2020

Last Updated

March 3, 2021

Record last verified: 2021-03

Locations