Flourishing App: An Evaluation With High School Students

Emotional Stress Clinical Trial

Official title:

Flourishing App: An Evaluation With High School Students

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03096171
• Other study ID #: HIAE_App Florescer_Alunos
• Status: Completed
• Phase: N/A
• First received: March 24, 2017
• Last updated: February 20, 2018
• Start date: March 28, 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: February 2018
• 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 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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 31, 2017
• Est. primary completion date: March 28, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 18 Years

Eligibility

Inclusion Criteria:

• Complete elementary school

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 16 weeks, with trainings of 20 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 stress in the last 30 days	Sliding scale for stress level from 0 to 100	baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks
Primary	Changes in subjective symptoms of well-being in the last 30 days	Sliding scale for well-being level from 0 to 100	baseline, 4 weeks, 8 weeks, 12 weeks and 16 weeks
Secondary	Changes in subjective symptoms of stress at the moment	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	Sliding scale for stress level from 0 to 100	four times a week, before and after the period of each class (20 min)