跳至主要内容
临床试验/NCT05085847
NCT05085847已完成不适用

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

University of Sao Paulo General Hospital1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Change from Baseline in inflammatory cytokines at 8-weeks.

研究概览

简要总结

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.

详细描述

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).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
23 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 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.

结局指标

主要结局

Change from Baseline in inflammatory cytokines at 8-weeks.

时间窗: 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

时间窗: 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

时间窗: 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.

时间窗: 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.

时间窗: 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.

次要结局

  • 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))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ana Flávia Marçal Pessoa

Co-investigator

University of Sao Paulo General Hospital

研究点 (1)

Loading locations...

相似试验

Effects of Mindfulness-based Intervention on... | 临床试验