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

Not Applicable
Completed
Conditions
Emotional Stress
Interventions
Behavioral: Flourishing protocol
Registration Number
NCT02164188
Lead Sponsor
Hospital Israelita Albert Einstein
Brief Summary

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

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
120
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Flourishing protocolFlourishing protocolThis group will receive the intervention Flourishing protocol and after that it will not receive any other intervention (cross over).
Primary Outcome Measures
NameTimeMethod
Change in perceived stress(baseline, 3 months, 6 months)

Lipp Stress Inventory; Perceived Stress Scale

Changes in well-beingbaseline, 3 months, 6 months

WHOQOL-bref (World Health Organization Quality of Life Questionnaire with 26 questions); Well-being at work scale; Psychological well-being scale.

Secondary Outcome Measures
NameTimeMethod
Change in cortisol levelsBaseline; 3 months; after 6 months

Saliva will be collected to measure cortisol levels: 7-9 am, 4-5 pm, 11-12 pm.

Trial Locations

Locations (1)

Hospital Israelita Albert Einstein

🇧🇷

Sao Paulo, Brazil

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