Overview

This trial is active, not recruiting.

Condition emotional stress
Treatment flourishing protocol
Sponsor Hospital Israelita Albert Einstein
Start date April 2014
End date August 2014
Trial size 120 participants
Trial identifier NCT02164188, HIAE_Florescer

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking open label
Arm
(No Intervention)
Initially this control group will not receive an intervention (wait list). After 8 weeks this goup will receive the Flourishing protocol (cross over).
(Experimental)
This group will receive the intervention Flourishing protocol and after that it will not receive any other intervention (cross over).
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.

Primary Outcomes

Measure
Change in perceived stress
time frame: (baseline, 3 months, 6 months)
Changes in well-being
time frame: baseline, 3 months, 6 months

Secondary Outcomes

Measure
Change in cortisol levels
time frame: Baseline; 3 months; after 6 months

Eligibility Criteria

Female participants from 25 years up to 60 years old.

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.

Additional Information

Official title The Flourishing Project: Evaluation of the Effectiveness of a Well-being Program in the Personal and Relational Dimensions
Principal investigator Elisa H Kozasa, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Hospital Israelita Albert Einstein.