- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03839030
Mindfulness-Based Health Promotion Program for Educators (MBHP - Educa). (Mindfulness)
Development and Implementation of Mindfulness-Based Health Promotion Program for Educators (MBHP - Educa): Evaluation of Cognitive Functions and Epigenetic Modifications.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
SP
-
São Paulo, SP, Brazil
- Centro Mente Aberta de Mindfulness e Promoção de Saúde
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: MBHP-Educa
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.
|
This intervention is a meditative practice which the individuals will practice in their daily life following the MBHP-educa protocol
|
NO_INTERVENTION: Control Group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
Pre-test, Post-test and follow-up (12 months)
|
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 |
Pre-test, Post-test and follow-up (12 months)
|
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)
|
Pre-test, Post-test and follow-up (12 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Glutathione metabolism from blood samples
Time Frame: Pre-test, Post-test and follow-up (12 months)
|
GSH plasma levels, Cysteine and homocisteine serum levels
|
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)
|
to evaluate the level of subjectively noticed stress, composed of 10 items
|
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)
|
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) |
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)
|
The CD-RISC is a 25-item measure of resilience.
|
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)
|
To evaluate positive and negative Affect through two subscales: positive affect - sum negative affect - sum
|
Pre-test, Post-test and follow-up (12 months)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Five Facet Mindfulness Questionnaire (FFMQ)
Time Frame: Pre-test, Post-test and follow-up (12 months)
|
To evaluate the mindfulness trace through five subscales: OBSERVING - mean DESCRIBING - mean NONJUDGE - mean NONREACT - mean ATC WITH AWARENESS - mean
|
Pre-test, Post-test and follow-up (12 months)
|
Rey Auditory-Verbal Learning Test - RAVLT
Time Frame: Pre-test, Post-test and follow-up (12 months)
|
To evaluate memory (number of word remember)
|
Pre-test, Post-test and follow-up (12 months)
|
Stroop test
Time Frame: Pre-test, Post-test and follow-up (12 months)
|
To evaluate attention and inhibitory behavior (number of errors and time)
|
Pre-test, Post-test and follow-up (12 months)
|
Digit span test
Time Frame: Pre-test, Post-test and follow-up (12 months)
|
To evaluate work memory (maximum lenght)
|
Pre-test, Post-test and follow-up (12 months)
|
Trail Making Test - TMT
Time Frame: Pre-test, Post-test and follow-up (12 months)
|
To evaluate attention (time to trail every letter or/and number)
|
Pre-test, Post-test and follow-up (12 months)
|
Hospital Anxiety and Depression Scale (HAADS)
Time Frame: Pre-test, Post-test and follow-up (12 months)
|
To evaluate anxiety and depression symptoms through two subscales: anxiety - sum depression - sum
|
Pre-test, Post-test and follow-up (12 months)
|
Burnout Clinical Subtypes Questionnaire - BCSQ-12
Time Frame: Pre-test, Post-test and follow-up (12 months)
|
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 |
Pre-test, Post-test and follow-up (12 months)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 92876418.2.0000.5505
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stress
-
Massachusetts General HospitalCompletedStress | Emotional Stress | Psychological Stress | Social Stress | Life StressUnited States
-
University of California, Los AngelesUniversity of California, San Francisco; Stanford University; California Initiative...Enrolling by invitationStress | Stress, Psychological | Stress, Emotional | Stress, Physiological | Stress ReactionUnited States
-
University of PadovaRecruitingStress | Stress Disorder | Work Related StressItaly
-
Dana-Farber Cancer InstituteEnrolling by invitationStress | Post Traumatic Stress Disorder | Work Related StressUnited States
-
Duquesne UniversityUniversity of California, San Diego; West Penn Allegheny Health System; El Centro... and other collaboratorsTerminated
-
University of Sao PauloCompleted
-
Syracuse VA Medical CenterUS Department of Veterans AffairsCompletedEmotional Stress | Psychological Stress | Life StressUnited States
-
Royal Cornwall Hospitals TrustEnrolling by invitationStress | Stress, Psychological | Stress, JobUnited Kingdom
-
Northumbria UniversityVolac International LtdRecruitingStress | Mood | Physiological StressUnited Kingdom
-
Taichung Veterans General HospitalUnknown
Clinical Trials on MBHP-Educa
-
Centro Mente Aberta de MindfulnessConselho Nacional de Desenvolvimento Científico e TecnológicoCompleted
-
Centro Mente Aberta de MindfulnessUnknown
-
Fundação Bahiana de InfectologiaMente AbertaRecruitingCovid19 | Posttraumatic Stress DisorderBrazil
-
Centro Mente Aberta de MindfulnessUnknown