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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02164188
Acronym
Flourishing
Enrollment
120
Registered
2014-06-16
Start date
2014-04-03
Completion date
2017-07-31
Last updated
2017-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Emotional Stress

Keywords

Stress, Well-being, Functional magnetic resonance imaging, Positive psychology

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.

Interventions

BEHAVIORALFlourishing 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.

Sponsors

Hospital Israelita Albert Einstein
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
25 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in perceived stress(baseline, 3 months, 6 months)Lipp Stress Inventory; Perceived Stress Scale
Changes in well-beingbaseline, 3 months, 6 monthsWHOQOL-bref (World Health Organization Quality of Life Questionnaire with 26 questions); Well-being at work scale; Psychological well-being scale.

Secondary

MeasureTime frameDescription
Change in cortisol levelsBaseline; 3 months; after 6 monthsSaliva will be collected to measure cortisol levels: 7-9 am, 4-5 pm, 11-12 pm.

Other

MeasureTime frameDescription
Changes in mindfulnessbaseline, 3 months, 6 monthsMindful Awareness Attention Scale
Changes in brain functionBaseline; 3 months; 6 monthsFunctional magnetic resonance imaging exams: emotional (International Affective Pictures System) and cognitive paradigms (Stroop Word Color Task and N-back).
Changes in Psychological capitalbaseline, 3 months, 6 monthsPsychological Capital Questionnaire
Changes in Positive and Negative Affectbaseline, 3 months, 6 monthsPANAS questionnaire
Changes in anxiety symptomsbaseline, 3 months,6 monthsBeck Anxiety Inventory
Changes in depression symptomsbaseline, 3 months, 6 monthsBeck Depression Inventory

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026