Flourishing App: An Evaluation With High School Students

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).

Study Overview

• Status: Completed
• Conditions: Emotional Stress
• Intervention / Treatment: Behavioral: Flourishing App Program

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05652901
    • Hospital Israelita Albert Einstein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Complete elementary school

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: 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).
Experimental: Flourishing App Program; This group will receive the intervention Flourishing App Program for 16 weeks.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Collaborators and Investigators

• Sponsor: Hospital Israelita Albert Einstein

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2016
• Primary Completion (Actual): March 28, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: March 24, 2017
• First Submitted That Met QC Criteria: March 24, 2017
• First Posted (Actual): March 30, 2017

Study Record Updates

• Last Update Posted (Actual): February 22, 2018
• Last Update Submitted That Met QC Criteria: February 20, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Stress; Well-being; Positive Psychology
• Other Study ID Numbers: HIAE_App Florescer_Alunos

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No