跳至主要内容
临床试验/NCT02164188
NCT02164188已完成不适用

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

Hospital Israelita Albert Einstein1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2014年4月3日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Change in perceived stress

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
None

入排标准

年龄范围
25 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者
是

入选标准

  • •Female aging from 25 to 60
  • •Managers from Natura Company or healthcare professionals from Hospital Israelita Albert Einstein

排除标准

  • •Sever mental or physical diseases
  • •For fMRI we will exclude participants who don´t match the criteria to undergoing this exam.

研究组 & 干预措施

control

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).

Flourishing protocol

Experimental

This group will receive the intervention Flourishing protocol and after that it will not receive any other intervention (cross over).

干预措施: Flourishing protocol (Behavioral)

结局指标

主要结局

Change in perceived stress

时间窗: (baseline, 3 months, 6 months)

Lipp Stress Inventory; Perceived Stress Scale

Changes in well-being

时间窗: baseline, 3 months, 6 months

WHOQOL-bref (World Health Organization Quality of Life Questionnaire with 26 questions); Well-being at work scale; Psychological well-being scale.

次要结局

  • Change in cortisol levels(Baseline; 3 months; after 6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Elisa Kozasa

PhD

Hospital Israelita Albert Einstein

研究点 (1)

Loading locations...

相似试验