NCT03096171

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 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 28, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 24, 2017

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 30, 2017

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

February 22, 2018

Status Verified

February 1, 2018

Enrollment Period

1 year

First QC Date

March 24, 2017

Last Update Submit

February 20, 2018

Conditions

Keywords

StressWell-beingPositive Psychology

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Changes in subjective symptoms of stress at the moment

    four times a week, before and after the period of each class (20 min)

  • Changes in subjective symptoms of well-being at the moment

    four times a week, before and after the period of each class (20 min)

Study Arms (2)

Control App

NO INTERVENTION

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

Flourishing App Program

EXPERIMENTAL

This group will receive the intervention Flourishing App Program for 16 weeks.

Behavioral: Flourishing App Program

Interventions

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.

Flourishing App Program

Eligibility Criteria

Age14 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Complete elementary school

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, 05652901, Brazil

Location

MeSH Terms

Conditions

Stress, Psychological

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: 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. No Intervention: Control App This group will observe their psychological and physical condition (levels of stress and well-being) during their daily activities and social interactions for 8 weeks. After the evaluations, this group will receive the intervention (Flourishing App Program) for more 8 weeks.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 24, 2017

First Posted

March 30, 2017

Study Start

March 28, 2016

Primary Completion

March 28, 2017

Study Completion

December 31, 2017

Last Updated

February 22, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations