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

Emotional Stress Clinical Trial

— Flourishing  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02164188
• Other study ID #: HIAE_Florescer
• Status: Completed
• Phase: N/A
• First received: April 29, 2014
• Last updated: August 9, 2017
• Start date: April 3, 2014
• Est. completion date: July 31, 2017

Study information

• Verified date: August 2017
• Source: Hospital Israelita Albert Einstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 31, 2017
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Emotional Stress
• Stress, Psychological

Intervention

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.

Locations

Country	Name	City	State
Brazil	Hospital Israelita Albert Einstein	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Changes in anxiety symptoms	Beck Anxiety Inventory	baseline, 3 months,6 months
Other	Changes in depression symptoms	Beck Depression Inventory	baseline, 3 months, 6 months
Other	Changes in mindfulness	Mindful Awareness Attention Scale	baseline, 3 months, 6 months
Other	Changes in Positive and Negative Affect	PANAS questionnaire	baseline, 3 months, 6 months
Other	Changes in Psychological capital	Psychological Capital Questionnaire	baseline, 3 months, 6 months
Primary	Change in perceived stress	Lipp Stress Inventory; Perceived Stress Scale	(baseline, 3 months, 6 months)
Primary	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	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

External 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.