Ignite Creation Date:
2024-05-06 @ 2:56 AM
Last Modification Date:
2024-10-26 @ 11:26 AM
Study NCT ID:
NCT02164188
Status:
COMPLETED
Last Update Posted:
2017-08-10
First Post:
2014-04-29
Brief Title:
The Flourishing Project Evaluation of the Effectiveness of a Well-being Program
Sponsor:
Hospital Israelita Albert Einstein
Organization:
Hospital Israelita Albert Einstein
Study Overview
Official Title:
The Flourishing Project Evaluation of the Effectiveness of a Well-being Program in the Personal and Relational Dimensions
Status:
COMPLETED
Status Verified Date:
2017-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Flourishing
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 InovaçãoCosméticos 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 InovaçãoCosméticos 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 InovaçãoCosméticos and health care professionals who work in a hospital Hospital Israelita Albert Einstein as well as its implication in the work environment MethodsSixty participants from Natura InovaçãoCosméticos 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None