MindfulnessNCT05085847
Effects of Mindfulness-based Intervention on Epigenetic Mechanisms, Cognition Function, Stress Response, and Well-being
A study testing Mindfulness meditation training in people with Mindfulness and DNA Methylation, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
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. 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
- Mindfulness, DNA Methylation, Learning and Memory
- What is being tested?
- Mindfulness meditation training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2018to 1 Oct 2019
- 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
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Being tested
- Mindfulness meditation training, Active control
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness meditation trainingOther
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 controlOther
Participants will receive lectures that provide cognitive and sensorial stimulus which does not specifically involve awareness training (meditation). Lesson topics include science.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based intervention (MBI) | Experimental | Participants received mindfulness training for 8 weeks (two-hour meetings; 16 hours total) Receives: Other: Mindfulness meditation training |
| Active control group | Active comparator | Participants received lectures for 8 weeks (two-hour meetings; 16 hours total) Receives: Other: Active control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Perceived Stress on the Perceived Stress Scale (PSS-10) at 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.
Measured: Baseline and Post-intervention (after 8 weeks)
Change from Baseline in Phycological Well-being on the Psychological Well-being Scale (SWB) at 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)
Measured: Baseline and Post-intervention (after 8 weeks)
Change from Baseline in DNA methylation at 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.
Measured: Baseline and Post-intervention (after 8 weeks)
Change from Baseline in inflammatory cytokines at 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.
Measured: Baseline and Post-intervention (after 8 weeks)
Change from Baseline in Cognitive function at 8-weeks.
Three different neuropsychological tests will be used to evaluate the cognitive function as know:
- Rey Auditory Verbal Learning Test (RAVLT) is a neuropsychological validated test to assess verbal learning and memory, an assessment of verbal learning over 5 trials, and 30-minute delayed free recall. The test will be applied according to the validation guideline's recommendations.
- Trail Making Test (TMT) is a neuropsychological validated test access frontal executive function. The test consists of two parts; the TMT A is a test of visual search and motor speed, whereas the TMT B measures cognitive flexibility, divided attention, and working memory. The test will be applied according to the validation guideline's recommendations.
- Stroop Color-Word Test is a validated test used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus. The test comprised four white cards, each 14 × 21.5 cm in size.
Measured: Baseline and Post-intervention (after 8 weeks)
Secondary outcomes (3)
Change from Baseline in Positive affect and negative affect at 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
Measured: Baseline and Post-intervention (after 8 weeks)
Change from Baseline in resilience at 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
Measured: Baseline and Post-intervention (after 8 weeks)
Change from Baseline in sleep quality of at 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.
Measured: Baseline and Post-intervention (after 8 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start1 Sep 2018
- Primary completion31 Aug 2019
- Study completion1 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MindfulnessStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of São Paulo
- Responsible party
- Principal investigator, Ana Flávia Marçal Pessoa, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05085847
- Sponsor's protocol ID
- 3.159.669
- Status last verified
- Nov 2021
- First submitted
- 17 Jun 2021
- Last updated
- 16 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular and Epigenetic Mechanisms Underlying Cognition Functions and Stress Response: Mindfulness-based Intervention
- ClinicalTrials.gov ID
- NCT05085847
- Acronym / sponsor ID
- 3.159.669
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Federal University of São Paulo
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 1 Oct 2019 (actual)
- First posted
- 20 Oct 2021 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based intervention (MBI) | Experimental | Other: Mindfulness meditation trainingParticipants received mindfulness training for 8 weeks (two-hour meetings; 16 hours total) |
| Active control group | Active comparator | Other: Active controlParticipants received lectures for 8 weeks (two-hour meetings; 16 hours 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 (5 listed)
- 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.
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 |
|---|---|---|
| Mindfulness meditation trainingMindfulness-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. | Other | Mindfulness-based intervention (MBI) |
| Active controlParticipants will receive lectures that provide cognitive and sensorial stimulus which does not specifically involve awareness training (meditation). Lesson topics include science. | Other | Active control group |
Primary outcome
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.
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)
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.
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.
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: 1. Rey Auditory Verbal Learning Test (RAVLT) is a neuropsychological validated test to assess verbal learning and memory, an assessment of verbal learning over 5 trials, and 30-minute delayed free recall. The test will be applied according to the validation guideline's recommendations. 2. Trail Making Test (TMT) is a neuropsychological validated test access frontal executive function. The test consists of two parts; the TMT A is a test of visual search and motor speed, whereas the TMT B measures cognitive flexibility, divided attention, and working memory. The test will be applied according to the validation guideline's recommendations. 3. Stroop Color-Word Test is a validated test used to assess the ability to inhibit cognitive interference that occurs when the processing of a specific stimulus. The test comprised four white cards, each 14 × 21.5 cm in size.
3 secondary outcomes
Change from Baseline in Positive affect and negative affect at 8-weeks.
Time frame: Baseline and Post-intervention (after 8 weeks)
Change from Baseline in resilience at 8-weeks.
Time frame: 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)
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 16 Nov 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness meditation training in people with Mindfulness and DNA Methylation, run by University of Sao Paulo General Hospital 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 5 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 16 Nov 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?
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)). The study lists 5 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 16 Nov 2021.