Emotional StressFlourishingNCT02164188
The Flourishing Project: Evaluation of the Effectiveness of a Well-being Program
A study testing Flourishing protocol in people with Emotional Stress, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Emotional Stress
- What is being tested?
- Flourishing protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBrazil
- Study dates
- 3 Apr 2014to 31 Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female aging from 25 to 60
- Managers from Natura Company or healthcare professionals from Hospital Israelita Albert Einstein
Who cannot join
- Sever mental or physical diseases
- For fMRI we will exclude participants who don´t match the criteria to undergoing this exam.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Flourishing Project: Evaluation of the Effectiveness of a Well-being Program in the Personal and Relational Dimensions
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).
Read the 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 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.
- Conditions
- Emotional Stress
- Being tested
- Flourishing protocol
- Keywords
- Stress, Well-being, Functional magnetic resonance imaging, Positive psychology
- Medical subject headings
- Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flourishing protocolBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Flourishing protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in perceived stress
Lipp Stress Inventory; Perceived Stress Scale
Measured: (baseline, 3 months, 6 months)
Changes in well-being
WHOQOL-bref (World Health Organization Quality of Life Questionnaire with 26 questions); Well-being at work scale; Psychological well-being scale.
Measured: baseline, 3 months, 6 months
Secondary outcomes (1)
Change in cortisol levels
Saliva will be collected to measure cortisol levels: 7-9 am, 4-5 pm, 11-12 pm.
Measured: Baseline; 3 months; after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study start3 Apr 2014
- Primary completion31 Jul 2017
- Study completion31 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisa Kozasa, Hospital Israelita Albert Einstein
- Investigators
- Elisa H Kozasa, PhD, Principal investigator, Instituto do Cérebro- Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02164188
- Sponsor's protocol ID
- HIAE_Florescer
- Acronym
- Flourishing
- Status last verified
- Aug 2017
- First submitted
- 29 Apr 2014
- Last updated
- 10 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Flourishing Project: Evaluation of the Effectiveness of a Well-being Program in the Personal and Relational Dimensions
- ClinicalTrials.gov ID
- NCT02164188
- Acronym / sponsor ID
- Flourishing / HIAE_Florescer
- Conditions
- Emotional Stress
- Keywords
- Stress, Well-being, Functional magnetic resonance imaging, Positive psychology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Study start
- 3 Apr 2014 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 31 Jul 2017 (actual)
- First posted
- 16 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Behavioral: Flourishing protocolThis group will receive the intervention Flourishing protocol and after that it will not receive any other intervention (cross over). |
Who may qualify
- Ages
- 25 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Female aging from 25 to 60
- Managers from Natura Company or healthcare professionals from Hospital Israelita Albert Einstein
Key exclusion criteria (2 listed)
- Sever mental or physical diseases
- For fMRI we will exclude participants who don´t match the criteria to undergoing this exam.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flourishing protocolThis 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. | Behavioural | Flourishing protocol |
Primary outcome
Change in perceived stress
Time frame: (baseline, 3 months, 6 months)
Lipp Stress Inventory; Perceived Stress Scale
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.
1 secondary outcome
Change in cortisol levels
Time frame: Baseline; 3 months; after 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2017.
- A yoga and compassion meditation program reduces stress in familial caregivers of Alzheimer's disease patients.Link provided by the sponsor.
- Meditation training increases brain efficiency in an attention task.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elisa H Kozasa, PhD principal investigator
Instituto do Cérebro- Hospital Israelita Albert Einstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Flourishing protocol in people with Emotional Stress, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in perceived stress (time frame: (baseline, 3 months, 6 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2017.