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

Study Overview
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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.

Official Title
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The Flourishing Project: Evaluation of the Effectiveness of a Well-being Program in the Personal and Relational Dimensions

Conditions
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Emotional Stress

Intervention / Treatment
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* Behavioral: Flourishing protocol


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>Initially this control group will not receive an intervention (wait list). After 8 weeks this goup will receive the Flourishing protocol (cross over). | |
| Experimental: Flourishing protocol<br>This group will receive the intervention Flourishing protocol and after that it will not receive any other intervention (cross over). | Behavioral: Flourishing protocol<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in perceived stress | Lipp Stress Inventory; Perceived Stress Scale | (baseline, 3 months, 6 months) | 
| Changes in well-being | WHOQOL-bref (World Health Organization Quality of Life Questionnaire with 26 questions); Well-being at work scale; Psychological well-being scale. | baseline, 3 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cortisol levels | Saliva will be collected to measure cortisol levels: 7-9 am, 4-5 pm, 11-12 pm. | Baseline; 3 months; after 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stress, Well-being, Functional magnetic resonance imaging, Positive psychology