Flourishing App: Evaluation of the Effectiveness of a Well-being Application for Mobile Devices

NCT ID: NCT02637414

Last Updated: 2017-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-06-30

Brief Summary

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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 employees who work in a company (Natura Inovação/Cosméticos) and in a hospital (Hospital Israelita Albert Einstein).

Methods: Two hundred and fifty employees from Natura Inovação/Cosméticos and 250 employees from Hospital Israelita Albert Einstein will be recruited. The participants will be randomized in two groups of 125 participants each one, half of them in the control group (GC) and the other half to the intervention group (GI), by institution.

Detailed Description

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Introduction: Stress related disorders may result in absenteeism and less productivity in companies. 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 not all people are willing to attend classroom training for several reasons. In this sense, 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 employees who work in a company (Natura Inovação/Cosméticos) and in a hospital (Hospital Israelita Albert Einstein).

Methods: Two hundred and fifty employees from Natura Inovação/Cosméticos and 250 employees from Hospital Israelita Albert Einstein will be recruited. The participants will be randomized in two groups of 125 participants each one, half of them in the control group (GC) and the other half to the intervention group (GI), by institution. 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 not receive any intervention. 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.

Conditions

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Emotional Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control App

Initially this control group will have access to a Control App and after 8 weeks this goup will receive the intervention (Flourishing App Program).

Group Type NO_INTERVENTION

No interventions assigned to this group

Flourishing App Program

This group will receive the intervention Flourishing App Program and after that it will not receive any other intervention.

Group Type EXPERIMENTAL

Flourishing App Program

Intervention Type BEHAVIORAL

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 8 weeks, with trainings of 15 to 25 minutes, four times a week.

Interventions

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Flourishing App Program

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 8 weeks, with trainings of 15 to 25 minutes, four times a week.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Female aging from 18 to 60
* Complete higher education
* Employees from Natura Inovação/Cosméticos and from Hospital Israelita Albert Einstein

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital Israelita Albert Einstein

OTHER

Sponsor Role lead

Responsible Party

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Elisa Kozasa

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Elisa H Kozasa, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto do Cérebro- Hospital Israelita Albert Einstein

Locations

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Hospital Israelita Albert Einstein

São Paulo, , Brazil

Site Status

Countries

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Brazil

References

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Coelhoso CC, Tobo PR, Lacerda SS, Lima AH, Barrichello CRC, Amaro E Jr, Kozasa EH. A New Mental Health Mobile App for Well-Being and Stress Reduction in Working Women: Randomized Controlled Trial. J Med Internet Res. 2019 Nov 7;21(11):e14269. doi: 10.2196/14269.

Reference Type DERIVED
PMID: 31697244 (View on PubMed)

Other Identifiers

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HIAE_App Florescer

Identifier Type: -

Identifier Source: org_study_id

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