Effects of Mindfulness-based Intervention on Epigenetic Mechanisms, Cognition Function, Stress Response, and Well-being

Stress Clinical Trial

Official title:

Molecular and Epigenetic Mechanisms Underlying Cognition Functions and Stress Response: Mindfulness-based Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05085847
• Other study ID #: 3.159.669
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: October 1, 2019

Study information

• Verified date: November 2021
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 1, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 23 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

1. clinical diagnosis of depression

2. clinical diagnosis of anxiety disorders

3. clinical diagnosis of schizophrenia

4. report of an infectious condition in the last 15 days before collecting a blood sample;

5. had previously practiced or currently practicing meditation, yoga or Tai-Chi.

Related Conditions & MeSH terms

• DNA Methylation
• Learning and Memory
• Mindfulness
• Psychological Well-being
• Stress

Intervention

Other:
• Mindfulness meditation training
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 control
Participants will receive lectures that provide cognitive and sensorial stimulus which does not specifically involve awareness training (meditation). Lesson topics include science.

Locations

Country	Name	City	State
Brazil	Daniela Rodrigues de Oliveira	Sao Paulo

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Federal University of São Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline and Post-intervention (after 8 weeks)
Primary	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)	Baseline and Post-intervention (after 8 weeks)
Primary	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.	Baseline and Post-intervention (after 8 weeks)
Primary	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-1ß (IL-1ß) 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)
Primary	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.	Baseline and Post-intervention (after 8 weeks)
Secondary	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	Baseline and Post-intervention (after 8 weeks)
Secondary	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	Baseline and Post-intervention (after 8 weeks)
Secondary	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.	Baseline and Post-intervention (after 8 weeks)