Clinical trial NCT02637414: Flourishing App: Evaluation of the Effectiveness of a Well-being Application for Mobile Devices
Official title: Flourishing App: Evaluation of the Effectiveness of a Well-being Application for Mobile Devices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotional Stress
Keywords: Stress
Well-being
Positive psychology
Lead sponsor: Hospital Israelita Albert Einstein
Sponsor class: OTHER
First posted: 2015-12-22
Enrollment: 500
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in subjective symptoms of well-being at work
timeFrame: baseline, 4 weeks, 8 weeks
measure: Changes in subjective symptoms of stress
timeFrame: baseline, 4 weeks, 8 weeks
Secondary outcomes:
measure: Changes in subjective symptoms of stress at the moment assessed using the sliding scale for stress
timeFrame: four times a week, before and after the period of each class (20 min)
measure: Changes in subjective symptoms of well-being at the moment assessed using the sliding scale for well-being
timeFrame: four times a week, before and after the period of each class (20 min)
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Hospital Israelita Albert Einstein
Study officials:
affiliation: Instituto do Cérebro- Hospital Israelita Albert Einstein
name: Elisa H Kozasa, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.