The Flourishing Project: Evaluation of the Effectiveness of a Well-being Program

NCT ID: NCT02164188

Last Updated: 2017-08-10

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-03

Study Completion Date

2017-07-31

Brief Summary

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This protocol proposes a well-being program based on meditation and Positive Psychology principles such as human development, the improvement of virtues, quality of life and well-being. The investigators hypothesize that this program may promote well-being and reduce stress related problems in the participants. Objectives: To evaluate the efficacy of a well-being program in a sample of managers who work in a company (Natura Inovação/Cosméticos ) and health care professionals who work in a hospital (Hospital Israelita Albert Einstein) as well as its implication in the work environment. Methods: Sixty managers from Natura Inovação/Cosméticos and 60 health professionals from Hospital Israelita Albert Einstein will be recruited. The participants will be randomized in two groups of 30 participants each one, half of them in the control group (GC) and the other half to the intervention group (GI).

Detailed Description

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Introduction: Stress related disorders may lead to mental disorders as well as cardiovascular problems. They may also result in absenteeism and less productivity in companies. This protocol proposes a well-being program based on meditation and Positive Psychology principles such as human development, the improvement of virtues, quality of life and well-being. The investigators hypothesize that this program may promote well-being and reduce stress related problems in the participants. Objectives: To evaluate the efficacy of a well-being and quality of life program in a sample of managers who work in a company (Natura Inovação/Cosméticos ) and health care professionals who work in a hospital (Hospital Israelita Albert Einstein) as well as its implication in the work environment. Methods:Sixty participants from Natura Inovação/Cosméticos and 60 health professionals from Hospital Israelita Albert Einstein will be recruited. The participants will be randomized in two groups of 30 participants each one, half of them in the control group (GC) and the other half to the intervention group (GI). This is a cross-over study. After the first evaluation GI will participate in the Flourishing Program for 8 weeks and the GC will be a wait-list group in this period of time. After that, there is a second evaluation of the participants and the GC will receive the intervention (Flourishing Program). GI will not receive any intervention during this new period of 8 weeks. A final evaluation will happen after that. The participants will fill in questionnaires (to evaluate depression, anxiety, stress, positive and negative affects, sleep quality, self-compassion, mindfulness, virtues, values, happiness, psychological well-being) and will be clinically examined; their blood sample will be collected (for the dosage of health related biomarkers) and also saliva for cortisol measures. They will perform structural and functional neuroimaging exams (emotional and cognitive paradigms) and their physiological measures such as skin conductance will be recorded.

Conditions

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Emotional Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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control

Initially this control group will not receive an intervention (wait list). After 8 weeks this goup will receive the Flourishing protocol (cross over).

Group Type NO_INTERVENTION

No interventions assigned to this group

Flourishing protocol

This group will receive the intervention Flourishing protocol and after that it will not receive any other intervention (cross over).

Group Type EXPERIMENTAL

Flourishing protocol

Intervention Type BEHAVIORAL

This intervention is based on relaxation, well-being promotion, meditation practices, positive psychology principles. The format is 1hour and half meetings during 8 weeks, and daily practices. MP3 audios are presented for daily practices.

Interventions

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Flourishing protocol

This intervention is based on relaxation, well-being promotion, meditation practices, positive psychology principles. The format is 1hour and half meetings during 8 weeks, and daily practices. MP3 audios are presented for daily practices.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Female aging from 25 to 60
* Managers from Natura Company or healthcare professionals from Hospital Israelita Albert Einstein

Exclusion Criteria

* Sever mental or physical diseases
* For fMRI we will exclude participants who don´t match the criteria to undergoing this exam.
Minimum Eligible Age

25 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Israelita Albert Einstein

OTHER

Sponsor Role lead

Responsible Party

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Elisa Kozasa

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elisa H Kozasa, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto do Cérebro- Hospital Israelita Albert Einstein

Locations

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Hospital Israelita Albert Einstein

São Paulo, , Brazil

Site Status

Countries

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Brazil

Related Links

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http://www.ncbi.nlm.nih.gov/pubmed/23690846

A yoga and compassion meditation program reduces stress in familial caregivers of Alzheimer's disease patients.

http://www.ncbi.nlm.nih.gov/pubmed/21763432

Meditation training increases brain efficiency in an attention task.

Other Identifiers

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HIAE_Florescer

Identifier Type: -

Identifier Source: org_study_id

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