- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05085847
Effects of Mindfulness-based Intervention on Epigenetic Mechanisms, Cognition Function, Stress Response, and Well-being
November 7, 2021 updated by: Ana Flávia Marçal Pessoa, University of Sao Paulo General Hospital
Molecular and Epigenetic Mechanisms Underlying Cognition Functions and Stress Response: Mindfulness-based Intervention
The purpose of this study is to assess the effect of a mindfulness-based intervention on DNAmethylation, cognitive functions, stress response, and well-being in healthy female adults.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
After being informed about the study and potential risks, all volunteers giving written informed consent will undergo a 1-3 week screening period to determine eligibility for study entry.
At week 0, volunteers who meet the eligibility requirements will be randomized in a 1:1 ratio to the active control group (8-week, 2 hours/week of lectures) or mindfulness-based intervention (8-week, 2 hours/week of mindfulness meditation training).
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Sao Paulo, Brazil
- Daniela Rodrigues de Oliveira
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
23 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- (1) Brazilian male or female aged between 23 and 65 years and (2) currently working in the classroom
Exclusion Criteria:
- clinical diagnosis of depression
- clinical diagnosis of anxiety disorders
- clinical diagnosis of schizophrenia
- report of an infectious condition in the last 15 days before collecting a blood sample;
- had previously practiced or currently practicing meditation, yoga or Tai-Chi.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mindfulness-based intervention (MBI)
Participants received mindfulness training for 8 weeks (two-hour meetings; 16 hours total)
|
Mindfulness-based intervention encompasses different practices which intend to exercise awareness by using mindfulness meditation training moment by moment.
Thus, practices such as mindful breathing, compassionate communication, loving-kindness, self-compassion, mindful listening, dealing with difficulties, the 3 step meditation, walking meditation, body scan with progressive relaxation, thoughts, emotions, gratitude, and sounds and breathing will be teaching to participants.
Mindfulness training will be conduct by two instructors with more than 30 years' experience in meditation practices (Zen and Tibetan Buddhist approach to mind-training) and extensive mindfulness teaching and practices (> 5 years each) experiences.
|
Active Comparator: Active control group
Participants received lectures for 8 weeks (two-hour meetings; 16 hours total)
|
Participants will receive lectures that provide cognitive and sensorial stimulus which does not specifically involve awareness training (meditation).
Lesson topics include science.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in Perceived Stress on the Perceived Stress Scale (PSS-10) at 8-weeks
Time Frame: Baseline and Post-intervention (after 8 weeks)
|
Perceived Stress Scale is a validated instrument designed to evaluate the level of subjectively noticed stress, composed of 10 items, 6 of which scoring positively, and 4 scoring negatively, using a Likert-kind frequency scale.
The answers range from "Never" (0) to "Always" (4), and the scoring show a crescendo proportional to the experimented stress (0-7 indicating very low stress; 8-11, low stress; 12-15 require attention, 16-20, high stress; above 21, very high stress.
|
Baseline and Post-intervention (after 8 weeks)
|
Change from Baseline in Phycological Well-being on the Psychological Well-being Scale (SWB) at 8-weeks
Time Frame: Baseline and Post-intervention (after 8 weeks)
|
The 42-item Psychological Wellbeing (PWB) Scale is a validated instrument designed to measures six aspects of wellbeing and happiness: autonomy, environmental mastery, personal growth, positive relations with others, purpose in life, and self-acceptance.
Respondents rate how strongly they agree or disagree with 42 statements using a 7-point scale (1 = strongly agree; 7 = strongly disagree)
|
Baseline and Post-intervention (after 8 weeks)
|
Change from Baseline in DNA methylation at 8-weeks.
Time Frame: Baseline and Post-intervention (after 8 weeks)
|
DNA methylation analysis will be performed in blood samples from participants.
DNA will be extracted from blood samples and genomic DNA will be converted using EZ® DNA Methylation Gold Kit (Zymo Research, Irvine, CA.) according to the manufacturer's recommendations.
Methylation analysis by pyrosequencing of bisulfite-treated genomic DNA was performed by PSQ96ID Pyrosequencer (Qiagen®, Valencia, CA) with reagents PyroMark Gold Q96 (Qiagen®, Valencia, CA) according to the manufacturer's protocol.
|
Baseline and Post-intervention (after 8 weeks)
|
Change from Baseline in inflammatory cytokines at 8-weeks.
Time Frame: Baseline and Post-intervention (after 8 weeks)
|
Serum samples were obtained through the collection of peripheral blood of the participants.
The level of the inflammatory cytokines interleukin-8 (IL-8) pg/mL, interleukin-1β (IL-1β) pg/mL, interleukin-6 (IL-6) pg/mL, interleukin-10 (IL-10) pg/mL, tumor necrosis factor (TNF) pg/mLe interleukin-12p70 (IL-12p70) pg/mL was determined using the Cytometric Bead Array (CBA) Human Inflammatory Cytokines Kit (BD Biosciences, San Jose, CA) and flow cytometry using the FACSCanto II (BD Biosciences, San Jose, CA) cytometer.
|
Baseline and Post-intervention (after 8 weeks)
|
Change from Baseline in Cognitive function at 8-weeks.
Time Frame: Baseline and Post-intervention (after 8 weeks)
|
Three different neuropsychological tests will be used to evaluate the cognitive function as know:
|
Baseline and Post-intervention (after 8 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from Baseline in Positive affect and negative affect at 8-weeks.
Time Frame: Baseline and Post-intervention (after 8 weeks)
|
The Positive affect and negative affect scale (PANAS) is evaluate the predominance of positive and negative affects within one's emotional landscape, measures are collected from a 0 ("not a bit") up to 5 ("extremely") range of answers to 20 questions, 10 of which versing about positive affects and dispositions, and 10 about negative emotions and dispositions
|
Baseline and Post-intervention (after 8 weeks)
|
Change from Baseline in resilience at 8-weeks.
Time Frame: Baseline and Post-intervention (after 8 weeks)
|
The Connor-Davidson Resilience Rating Scale ( CD-RISC )is a 25-item measure of resilience.
Each item ranges from 0 ("not true at all") up to 4 ("true nearly all the time").
The final scores are obtained by summing the response to each of the items, with higher values indicating higher levels of resilience
|
Baseline and Post-intervention (after 8 weeks)
|
Change from Baseline in sleep quality of at 8-weeks.
Time Frame: Baseline and Post-intervention (after 8 weeks)
|
The Pittsburgh Sleep Quality Index (PSQI) provides a subjective measure of sleep quality and patterns.PSQI, a self-administered questionnaire, includes four open-ended questions and 14 questions to be answered using event-frequency and semantic scales.
(The latter use paired words of opposite meaning, such as good-bad.)
The tool looks at seven areas: subjective sleep quality, sleep latency (the time it takes to fall asleep), sleep duration, habitual sleep efficiency (the ratio of total sleep time to time in bed), sleep disturbances, the use of sleep-promoting medication (prescribed or over-the-counter), and daytime dysfunction.The PSQI includes a scoring key for calculating a patient's seven subscores, each of which can range from 0 to 3. The subscores are tallied, yielding a "global" score that can range from 0 to 21.
A global score of 5 or more indicates poor sleep quality; the higher the score, the worse the quality.
|
Baseline and Post-intervention (after 8 weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2018
Primary Completion (Actual)
August 31, 2019
Study Completion (Actual)
October 1, 2019
Study Registration Dates
First Submitted
June 17, 2021
First Submitted That Met QC Criteria
October 7, 2021
First Posted (Actual)
October 20, 2021
Study Record Updates
Last Update Posted (Actual)
November 16, 2021
Last Update Submitted That Met QC Criteria
November 7, 2021
Last Verified
November 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 3.159.669
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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 PadovaRecruitingStress | Stress Disorder | Work Related StressItaly
-
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
-
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 Mindfulness meditation training
-
Emory UniversityCompletedBehavioral Resilience | Biological ResilienceUnited States
-
Sandraluz Lara-CinisomoCompletedStress, Depression, Anxiety and WorryUnited States
-
Wake Forest University Health SciencesWithdrawn
-
Colorado Joint ReplacementRecruitingSleep Disturbance | ArthropathyUnited States
-
Oregon Health and Science UniversityCompleted
-
University Hospital, CaenInstitut National de la Santé Et de la Recherche Médicale, France; Université... and other collaboratorsEnrolling by invitationProlonged Grief DisorderFrance
-
Oregon Health and Science UniversityCompletedCerebral Palsy | Physical Impairments | Cerebral Ataxia | locked-in SyndromeUnited States
-
Rennes University HospitalLaboratoire Traitement du Signal et de l'Image, INSERM UMR1099 Rennes; Centre...Recruiting
-
University of California, Los AngelesCompleted