跳至主要内容
临床试验/NCT04955457
NCT04955457已完成不适用

BDNF Promoter Methylation: Effects on Cognition, Stress and Anxiety and Depression Symptom in Healthy Women.

Ana Flávia Marçal Pessoa1 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
发起方
入组人数
100
试验地点
1
主要终点
Explore working memory in healthy women active teachers

研究概览

简要总结

The purpose of this study is to explore the association between BDNF methylation and neurocognitive performance, perceived stress, and well-being in healthy women.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

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 female aged between 23 and 65 years and (2) currently working in the classroom

排除标准

  • diagnosis of depression
  • diagnosis of anxiety disorder
  • diagnosis of squizofrenia
  • report of an infectious condition in the last 15 days before collecting a blood sample;

结局指标

主要结局

Explore working memory in healthy women active teachers

时间窗: Baseline

Investigates the capacity of working memory (auditory) and attention. It consists of two tables with different numbers, one with a direct order and another with a reverse order. The sequence of numbers is read aloud to the participant, one by one, where he must immediately repeat them to the examiner. The same happens with numbers in reverse order, but the participant must repeat the numbers backwards (reverse order). The maximum possible score to be reached in the forward order is 16 points, and in the reverse order 14 points totaling 30 points in the total score. For evaluation, the result must be compared with the standardization according to age.

Explore attention in healthy women active teachers

时间窗: Baseline

Trail Making Test (TMT): is used to assess divided attention, consisting of two parts (A and B). It also assesses motor function, mental flexibility, visual processing speed and aspects of sustained and alternating attention. In both parts, the participant must draw a path marked by numbers in the shortest time possible and without taking the pencil off the paper. In part A, you must draw a path marked by numbers in ascending order, from 1 to 25. Part B has a higher degree of difficulty, requiring greater cognitive demand from the participant, who must draw the path, now marked with numbers ranging from 1 to 13, alternating with letters, ranging from A to L, thus: 1-A-2-B-3-C... And so on. The score is measured by the total time the participant took to perform each task and compared with the standardization for their age group.

Explore selective attention in healthy women active teachers

时间窗: Baseline

• Stroop Test: Allows you to detect neurological and brain problems and is also used to check and measure levels of concentration and cognitive functions, selective attention and speed of processing information. The test must be applied to adults over 25 years of age and consists of three tasks: the first in reading words, the second in naming colors, and the third in identifying and naming the color of each word that is written in distinct colors from its nomenclature, which is called the interference effect (or stroop effect). The score is obtained by scoring total correct answers in each of these tasks, and compared with the current standardization.

Explore episodic memory in healthy women active teachers

时间窗: Baseline

The RAVLT is a validated neuropsychologic test to evaluate learning and memory (episodic memory)an assessment of verbal learning over 5 trials and 30-minute delayed free recall

Explore anxiety and depression symptoms in healthy women active teachers

时间窗: Baseline

• Hospital Anxiety and Depression Scale (HADS): It was developed to identify probable and possible levels and cases of Anxiety and Depression in clinical and non-clinical populations. It consists of 14 items divided into two subscales of 7 items each, where one comprises questions to identify signs of anxiety disorders, and the other of depression. The answers range from 0 to 3 points, ranging from absent to very frequent, with a maximum score of 21 points. The cutoff point obtained in the literature for both subscales is ≥ 9 points

Explore positive and negative affect in healthy women active teachers

时间窗: Baseline

• Positive and negative affect scale (PANAS): Aims to identify the dimensions of affect of subjective well-being, through 20 items provided, where participants must indicate how they have been feeling lately. These items are distributed into 10 of subjective emotions that comprise negative affects, and 10 items that comprise positive affects, being issued on a 5-point Likert scale ranging from 1 (not at all) to 5 (extremely).

Explore BDNF methylation level in healthy women active teachers

时间窗: baseline

Venous blood was obtained from all participants to DNA extraction and BDNF methylation analyses.

Explore perceived stress in healthy women active teachers

时间窗: Baseline

Perceived Stress Scale (PSS): is used to assess the individual's perception of stress (subjective stress assessment), where it should be noted how uncontrollable and unpredictable the events of their life experienced in the last month seem to be. The test consists of 10 items, 6 of positive aspects and 4 of negative aspects, and must be answered within a Likert-type frequency scale (ranging from 0 - Never to 4-Always). For its evaluation, all the answers must be added together to obtain a total perceived stress score, which must be compared with the standardization of the test for the equivalent population

Explore resilience in healthy women active teachers

时间窗: Baseline

• Connor-Davidson Resilience Scale (CD-RISC): a 25-item scale divided into 5 factors, namely: personal competence, confidence in one's instincts, positive acceptance of change, tolerance in the face of adversity, control and spirituality. The scale is self-applicable and the participant must mark answers ranging from 0 (never true) to 4 (always true). The result is obtained through the sum of the total score, which can range from 0 to 40 points, where the higher the score, the greater the participant's degree of resilience.

Explore psychological well-being in healthy women active teachers

时间窗: Baseline

• Psychological Well-Being Scale (PWBS): the scale consists of 84 items, subdivided into 6 scales that assess the dimensions of psychological well-being, with 14 items each. The answers are obtained through a Likert-type scale, ranging from 0 (totally disagree) to 6 (totally agree). The subscales are divided as follows: Self-acceptance, Positive relationship with others, autonomy, mastery of the environment, purpose in life and personal growth. The result is obtained through the sum of the items of each subscale, and the higher the score, the better the levels of psychological well-being according to each subscale.

次要结局

未报告次要终点

研究者

发起方
Ana Flávia Marçal Pessoa
申办方类型
Other
责任方
Sponsor 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

BDNF Promoter Methylation: Effects on Cognition,... | 临床试验