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

NCT ID: NCT05085847

Last Updated: 2021-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-10-01

Brief Summary

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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

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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).

Conditions

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Mindfulness DNA Methylation Learning and Memory Stress Psychological Well-being

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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Mindfulness-based intervention (MBI)

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

Group Type EXPERIMENTAL

Mindfulness meditation training

Intervention Type 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.

Active control group

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

Group Type ACTIVE_COMPARATOR

Active control

Intervention Type OTHER

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

Interventions

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Mindfulness meditation training

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.

Intervention Type OTHER

Active control

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. clinical diagnosis of depression
2. clinical diagnosis of anxiety disorders
3. clinical diagnosis of schizophrenia
4. report of an infectious condition in the last 15 days before collecting a blood sample;
5. had previously practiced or currently practicing meditation, yoga or Tai-Chi.
Minimum Eligible Age

23 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Federal University of São Paulo

OTHER

Sponsor Role collaborator

University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ana Flávia Marçal Pessoa

Co-investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Daniela Rodrigues de Oliveira

São Paulo, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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3.159.669

Identifier Type: -

Identifier Source: org_study_id