Effects of Mindfulness-based Intervention on Epigenetic Mechanisms, Cognition Function, Stress Response, and Well-being
- Conditions
- Psychological Well-beingDNA MethylationLearning and MemoryStressMindfulness
- Interventions
- Other: Mindfulness meditation trainingOther: Active control
- Registration Number
- NCT05085847
- Lead Sponsor
- University of Sao Paulo General Hospital
- 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
- (1) Brazilian male or female aged between 23 and 65 years and (2) currently working in the classroom
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mindfulness-based intervention (MBI) Mindfulness meditation training Participants received mindfulness training for 8 weeks (two-hour meetings; 16 hours total) Active control group Active control Participants received lectures for 8 weeks (two-hour meetings; 16 hours total)
- Primary Outcome Measures
Name Time Method Change from Baseline in inflammatory cytokines at 8-weeks. 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 Perceived Stress on the Perceived Stress Scale (PSS-10) at 8-weeks 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 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. 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 Cognitive function at 8-weeks. 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.
- Secondary Outcome Measures
Name Time Method Change from Baseline in Positive affect and negative affect at 8-weeks. 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
Change from Baseline in resilience at 8-weeks. 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
Change from Baseline in sleep quality of at 8-weeks. 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.
Trial Locations
- Locations (1)
Daniela Rodrigues de Oliveira
🇧🇷Sao Paulo, Brazil