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NCT Number: NCT02164188

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

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).

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Key information

Age range

25 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Israelita Albert Einstein

São Paulo, 05652901, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Flourishing protocol

Behavioral

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

  1. Change in perceived stress

    Time frame: (baseline, 3 months, 6 months)

    Lipp Stress Inventory; Perceived Stress Scale

  2. Changes in well-being

    Time frame: 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.

Secondary outcomes

  1. Change in cortisol levels

    Time frame: Baseline; 3 months; after 6 months

    Saliva will be collected to measure cortisol levels: 7-9 am, 4-5 pm, 11-12 pm.

Other outcomes

  1. Changes in brain function

    Time frame: Baseline; 3 months; 6 months

    Functional magnetic resonance imaging exams: emotional (International Affective Pictures System) and cognitive paradigms (Stroop Word Color Task and N-back).

  2. Changes in anxiety symptoms

    Time frame: baseline, 3 months,6 months

    Beck Anxiety Inventory

  3. Changes in depression symptoms

    Time frame: baseline, 3 months, 6 months

    Beck Depression Inventory

  4. Changes in mindfulness

    Time frame: baseline, 3 months, 6 months

    Mindful Awareness Attention Scale

  5. Changes in Positive and Negative Affect

    Time frame: baseline, 3 months, 6 months

    PANAS questionnaire

  6. Changes in Psychological capital

    Time frame: baseline, 3 months, 6 months

    Psychological Capital Questionnaire

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Registry information

Official study title

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

Acronym: Flourishing

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 16, 2014
Registry last updated
Aug 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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