- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03096171
Flourishing App: An Evaluation With High School Students
20. februar 2018 opdateret af: Elisa Kozasa, Hospital Israelita Albert Einstein
This protocol proposes a well-being program, delivered through an application for mobile devices, 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 offered in mobile application may promote well-being and reduce stress related problems in the participants.
Objectives: To evaluate the effectiveness of a well-being program delivered through an application for mobile devices in a sample of high school students.
Methods: Sixty high school students 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: Some very successful stress management programs are based on the principle of Mindfulness.
This protocol proposes a well-being program, delivered through an application for mobile devices, based on meditation and positive psychology principles such as human development, the improvement of virtues, quality of life and well-being.
In the modern world, young people are connected to new technologies and the use of applications can be a fun way to learn how to cope with stress and promote well-being.
In this sense, the investigators hypothesize that this program offered in mobile application can be considered an interesting alternative for high school students who want to reduce symptoms related to stress and also promote well-being.
Objectives: To evaluate the effectiveness of a well-being program delivered through an application for mobile devices in a sample of high school students.
Methods: Sixty high school students 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).
The GI will participate in the Flourishing App Program, for eight weeks, while the GC will have access to a Control App.
Then, after the evaluations, the GC will receive the intervention (Flourishing App Program), while the first group will repeat the use of the Flourishing App Program.
Questions will be applied to evaluate the levels of stress and well-being of participants before and after the program and before and after each training period.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
60
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
14 år til 18 år (Barn, Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Complete elementary school
Exclusion Criteria:
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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: Kontrol app
I første omgang vil denne kontrolgruppe have adgang til en kontrol-app, og efter 8 uger vil denne gruppe modtage interventionen (blomstrende app-program).
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Eksperimentel: Flourishing App Program
This group will receive the intervention Flourishing App Program for 16 weeks.
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This intervention is based on relaxation, well-being promotion, meditation practices and positive psychology principles.
The program is being evaluated in a classroom format into another project and was adapted for this project in the application format for mobile devices.
It will last for 16 weeks, with trainings of 20 minutes, four times a week.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Changes in subjective symptoms of stress in the last 30 days
Tidsramme: baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks
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Sliding scale for stress level from 0 to 100
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baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks
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Changes in subjective symptoms of well-being in the last 30 days
Tidsramme: baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks
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Sliding scale for well-being level from 0 to 100
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baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Changes in subjective symptoms of stress at the moment
Tidsramme: four times a week, before and after the period of each class (20 min)
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Sliding scale for stress level from 0 to 100
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four times a week, before and after the period of each class (20 min)
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Changes in subjective symptoms of well-being at the moment
Tidsramme: four times a week, before and after the period of each class (20 min)
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Sliding scale for stress level from 0 to 100
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four times a week, before and after the period of each class (20 min)
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
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)
28. marts 2016
Primær færdiggørelse (Faktiske)
28. marts 2017
Studieafslutning (Faktiske)
31. december 2017
Datoer for studieregistrering
Først indsendt
24. marts 2017
Først indsendt, der opfyldte QC-kriterier
24. marts 2017
Først opslået (Faktiske)
30. marts 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. februar 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. februar 2018
Sidst verificeret
1. februar 2018
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- HIAE_App Florescer_Alunos
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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Ingen
produkt fremstillet i og eksporteret fra U.S.A.
Ingen
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 .
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