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

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

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).

Study Overview

• Status: Completed
• Conditions: Emotional Stress
• Intervention / Treatment: Behavioral: Flourishing protocol

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05652901
    • Hospital Israelita Albert Einstein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control; 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; This group will receive the intervention Flourishing protocol and after that it will not receive any other intervention (cross over).	Behavioral: 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in brain function	Functional magnetic resonance imaging exams: emotional (International Affective Pictures System) and cognitive paradigms (Stroop Word Color Task and N-back).	Baseline; 3 months; 6 months
Changes in anxiety symptoms	Beck Anxiety Inventory	baseline, 3 months,6 months
Changes in depression symptoms	Beck Depression Inventory	baseline, 3 months, 6 months
Changes in mindfulness	Mindful Awareness Attention Scale	baseline, 3 months, 6 months
Changes in Positive and Negative Affect	PANAS questionnaire	baseline, 3 months, 6 months
Changes in Psychological capital	Psychological Capital Questionnaire	baseline, 3 months, 6 months

Collaborators and Investigators

• Sponsor: Hospital Israelita Albert Einstein
• Investigators: Principal Investigator: Elisa H Kozasa, PhD, Instituto do Cérebro- Hospital Israelita Albert Einstein

Publications and helpful links

Helpful Links

• A yoga and compassion meditation program reduces stress in familial caregivers of Alzheimer's disease patients.
• Meditation training increases brain efficiency in an attention task.

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2014
• Primary Completion (Actual): July 31, 2017
• Study Completion (Actual): July 31, 2017

Study Registration Dates

• First Submitted: April 29, 2014
• First Submitted That Met QC Criteria: June 13, 2014
• First Posted (Estimate): June 16, 2014

Study Record Updates

• Last Update Posted (Actual): August 10, 2017
• Last Update Submitted That Met QC Criteria: August 9, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Keywords: Stress; Positive psychology; Well-being; Functional magnetic resonance imaging
• Other Study ID Numbers: HIAE_Florescer