The Flourishing Project: Evaluation of the Effectiveness of a Well-being Program (Flourishing)
9. august 2017 opdateret af: Elisa Kozasa, Hospital Israelita Albert Einstein
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).
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Forventet)
120
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Sao Paulo, Brasilien, 05652901
- Hospital israelita Albert Einstein
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
25 år til 60 år (Voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
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.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Andet
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Ingen indgriben: control
Initially this control group will not receive an intervention (wait list).
After 8 weeks this goup will receive the Flourishing protocol (cross over).
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Eksperimentel: Flourishing protocol
This group will receive the intervention Flourishing protocol and after that it will not receive any other intervention (cross over).
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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.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in perceived stress
Tidsramme: (baseline, 3 months, 6 months)
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Lipp Stress Inventory; Perceived Stress Scale
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(baseline, 3 months, 6 months)
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Changes in well-being
Tidsramme: baseline, 3 months, 6 months
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WHOQOL-bref (World Health Organization Quality of Life Questionnaire with 26 questions); Well-being at work scale; Psychological well-being scale.
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baseline, 3 months, 6 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in cortisol levels
Tidsramme: Baseline; 3 months; after 6 months
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Saliva will be collected to measure cortisol levels: 7-9 am, 4-5 pm, 11-12 pm.
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Baseline; 3 months; after 6 months
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Changes in brain function
Tidsramme: Baseline; 3 months; 6 months
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Functional magnetic resonance imaging exams: emotional (International Affective Pictures System) and cognitive paradigms (Stroop Word Color Task and N-back).
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Baseline; 3 months; 6 months
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Changes in anxiety symptoms
Tidsramme: baseline, 3 months,6 months
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Beck Anxiety Inventory
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baseline, 3 months,6 months
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Changes in depression symptoms
Tidsramme: baseline, 3 months, 6 months
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Beck Depression Inventory
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baseline, 3 months, 6 months
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Changes in mindfulness
Tidsramme: baseline, 3 months, 6 months
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Mindful Awareness Attention Scale
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baseline, 3 months, 6 months
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Changes in Positive and Negative Affect
Tidsramme: baseline, 3 months, 6 months
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PANAS questionnaire
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baseline, 3 months, 6 months
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Changes in Psychological capital
Tidsramme: baseline, 3 months, 6 months
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Psychological Capital Questionnaire
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baseline, 3 months, 6 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Elisa H Kozasa, PhD, Instituto do Cérebro- Hospital Israelita Albert Einstein
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
3. april 2014
Primær færdiggørelse (Faktiske)
31. juli 2017
Studieafslutning (Faktiske)
31. juli 2017
Datoer for studieregistrering
Først indsendt
29. april 2014
Først indsendt, der opfyldte QC-kriterier
13. juni 2014
Først opslået (Skøn)
16. juni 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
10. august 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. august 2017
Sidst verificeret
1. august 2017
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- HIAE_Florescer
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .