NCT03895190

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, reduce stress related problems and improving emotional regulation in the participants. Objectives: To evaluate the effectiveness of a well-being program delivered through an application for mobile devices in a sample of medical students. Methods: Three hundred students of the undergraduate medical course of Albert Einstein Israelite Faculty will be recruited. The participants will be randomized in two groups of 150 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
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 27, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 29, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

August 6, 2019

Completed
26 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2020

Completed
Last Updated

April 24, 2020

Status Verified

March 1, 2019

Enrollment Period

26 days

First QC Date

March 27, 2019

Last Update Submit

April 22, 2020

Conditions

Keywords

well-beingstresspositive psychologymeditationmobile application (app)medical students

Outcome Measures

Primary Outcomes (2)

  • Changes in subjective symptoms of well-being at work

    Sliding scale for stress level from 0 to 100

    baseline, 4 weeks, 8 weeks

  • Changes in subjective symptoms of stress

    Sliding scale for well-being level from 0 to 100

    baseline, 4 weeks, 8 weeks

Secondary Outcomes (2)

  • Changes in subjective symptoms of stress at the moment assessed using the sliding scale for stress

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

  • Changes in subjective symptoms of well-being at the moment assessed using the sliding scale for well-being

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

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).

Experimental: Flourishing App Program

EXPERIMENTAL

This group will receive the intervention Flourishing App Program and after that it will not receive any other intervention.

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 8 weeks, with trainings of 15 to 25 minutes, four times a week.

Experimental: Flourishing App Program

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Women and men from 17 years
  • Students of the undergraduate medical course of Albert Einstein Israelite Faculty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, São Paulo, 05601-901, Brazil

Location

MeSH Terms

Conditions

Stress, PsychologicalAlzheimer Disease

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Elisa H Kozasa, PhD

    Instituto do Cérebro- Hospital Israelita Albert Einstein

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2019

First Posted

March 29, 2019

Study Start

August 6, 2019

Primary Completion

September 1, 2019

Study Completion

April 21, 2020

Last Updated

April 24, 2020

Record last verified: 2019-03

Locations