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

H

Hospital Israelita Albert Einstein

Status

Completed

Conditions

Emotional Stress

Treatments

Behavioral: Flourishing protocol

Study type

Interventional

Funder types

Other

Identifiers

NCT02164188
HIAE_Florescer

Details and patient eligibility

About

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).

Full 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.

Enrollment

120 estimated patients

Sex

Female

Ages

25 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

120 participants in 2 patient groups

control
No Intervention group
Description:
Initially this control group will not receive an intervention (wait list). After 8 weeks this goup will receive the Flourishing protocol (cross over).
Flourishing protocol
Experimental group
Description:
This group will receive the intervention Flourishing protocol and after that it will not receive any other intervention (cross over).
Treatment:
Behavioral: Flourishing protocol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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