Healthy women active teachers in Stress and Well-being and Memory Impairment - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Other: Healthy women active teachers

Study Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Brazil
- WI
  - Sao Paulo, WI, Brazil, 53703
    - Universidade Federal de Sao Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

23 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Female participants will be recruited from public schools linked to the "Diretoria Regional de Educação de Santo Amaro - DRESA" - a southern section of the São Paulo City Hall public education secretaryship.

Description

Inclusion Criteria: (1)Brazilian female aged between 23 and 65 years and (2) currently working in the classroom

Exclusion Criteria:

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Explore BDNF methylation level in healthy women active teachers Time Frame: baseline	Venous blood was obtained from all participants to DNA extraction and BDNF methylation analyses.	baseline
Explore episodic memory in healthy women active teachers Time Frame: 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	Baseline
Explore working memory in healthy women active teachers Time Frame: 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.	Baseline
Explore attention in healthy women active teachers Time Frame: 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.	Baseline
Explore selective attention in healthy women active teachers Time Frame: 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.	Baseline
Explore perceived stress in healthy women active teachers Time Frame: 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	Baseline
Explore resilience in healthy women active teachers Time Frame: 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.	Baseline
Explore psychological well-being in healthy women active teachers Time Frame: 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.	Baseline
Explore positive and negative affect in healthy women active teachers Time Frame: 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).	Baseline
Explore anxiety and depression symptoms in healthy women active teachers Time Frame: 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	Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ana Flávia Marçal Pessoa

Collaborators

Federal University of São Paulo

Investigators

Principal Investigator: Daniela Rodrigues de Oliveira, PhD, Federal University of São Paulo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2018

Primary Completion (ACTUAL)

June 1, 2019

Study Completion (ACTUAL)

June 1, 2019

Study Registration Dates

First Submitted

June 21, 2021

First Submitted That Met QC Criteria

July 7, 2021

First Posted (ACTUAL)

July 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

July 13, 2021

Last Update Submitted That Met QC Criteria