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

NCT05085847 | Completed

• 1 other identifier: 3.159.669
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• 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)

• 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)

• 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)

• 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.

  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: 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.

  Baseline and Post-intervention (after 8 weeks)

Secondary Outcomes (3)

• Change from Baseline in Positive affect and negative affect at 8-weeks.

  Baseline and Post-intervention (after 8 weeks)

• Change from Baseline in resilience at 8-weeks.

  Baseline and Post-intervention (after 8 weeks)

• Change from Baseline in sleep quality of at 8-weeks.

  Baseline and Post-intervention (after 8 weeks)

Study Arms (2)

Mindfulness-based intervention (MBI)

EXPERIMENTAL

Participants received mindfulness training for 8 weeks (two-hour meetings; 16 hours total)

Other: Mindfulness meditation training

Active control group

ACTIVE COMPARATOR

Participants received lectures for 8 weeks (two-hour meetings; 16 hours total)

Other: Active control

Interventions

Mindfulness meditation training OTHER

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.

Mindfulness-based intervention (MBI)

Active control OTHER

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

Active control group

Eligibility Criteria

• Age: 23 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead
• Federal University of São Paulo: collaborator

Study Sites (1)

Daniela Rodrigues de Oliveira

São Paulo, Brazil

Location

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior

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: PRINCIPAL INVESTIGATOR
• PI Title: Co-investigator

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: October 20, 2021
• Study Start: September 1, 2018
• Primary Completion: August 31, 2019
• Study Completion: October 1, 2019
• Last Updated: November 16, 2021

Record last verified: 2021-11

Locations

BR (1)