Clinical trial NCT02164188: The Flourishing Project: Evaluation of the Effectiveness of a Well-being Program
Official title: The Flourishing Project: Evaluation of the Effectiveness of a Well-being Program in the Personal and Relational Dimensions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotional Stress
Keywords: Stress
Well-being
Functional magnetic resonance imaging
Positive psychology
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
First posted: 2014-06-16
Enrollment: 120
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in perceived stress
timeFrame: (baseline, 3 months, 6 months)
measure: Changes in well-being
timeFrame: baseline, 3 months, 6 months
Secondary outcomes:
measure: Change in cortisol levels
timeFrame: Baseline; 3 months; after 6 months
Other outcomes:
measure: Changes in brain function
timeFrame: Baseline; 3 months; 6 months
measure: Changes in anxiety symptoms
timeFrame: baseline, 3 months,6 months
measure: Changes in depression symptoms
timeFrame: baseline, 3 months, 6 months
measure: Changes in mindfulness
timeFrame: baseline, 3 months, 6 months
measure: Changes in Positive and Negative Affect
timeFrame: baseline, 3 months, 6 months
measure: Changes in Psychological capital
timeFrame: baseline, 3 months, 6 months
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
Study officials:
affiliation: Instituto do Cérebro- Hospital Israelita Albert Einstein
name: Elisa H Kozasa, PhD
role: PRINCIPAL_INVESTIGATOR
References: