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

Emotional Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02637414
• Other study ID #: HIAE_App Florescer
• Status: Completed
• Phase: N/A
• First received: December 11, 2015
• Last updated: June 20, 2017
• Start date: January 2016
• Est. completion date: June 2017

Study information

• Verified date: June 2017
• Source: Hospital Israelita Albert Einstein
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: June 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Female aging from 18 to 60

• Complete higher education

• Employees from Natura Inovação/Cosméticos and from Hospital Israelita Albert Einstein

Exclusion Criteria:

Related Conditions & MeSH terms

• Emotional Stress
• Stress, Psychological

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Brazil	Hospital Israelita Albert Einstein	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Israelita Albert Einstein

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in subjective symptoms of well-being at work	Sliding scale for stress level from 0 to 100	baseline, 4 weeks, 8 weeks
Primary	Changes in subjective symptoms of stress	Sliding scale for well-being level from 0 to 100	baseline, 4 weeks, 8 weeks
Secondary	Changes in subjective symptoms of stress at the moment assessed using the sliding scale for stress	Sliding scale for stress level from 0 to 100	four times a week, before and after the period of each class (20 min)
Secondary	Changes in subjective symptoms of well-being at the moment assessed using the sliding scale for well-being	Sliding scale for well-being level from 0 to 100	four times a week, before and after the period of each class (20 min)