Effects of a Application (Flourish App) in Medical Students
1 other identifier
interventional
50
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2019
Shorter than P25 for not_applicable
1 active site
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
CompletedFirst Posted
Study publicly available on registry
March 29, 2019
CompletedStudy Start
First participant enrolled
August 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 21, 2020
CompletedApril 24, 2020
March 1, 2019
26 days
March 27, 2019
April 22, 2020
Conditions
Keywords
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 INTERVENTIONInitially 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
EXPERIMENTALThis group will receive the intervention Flourishing App Program and after that it will not receive any other intervention.
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.
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Elisa H Kozasa, PhD
Instituto do Cérebro- Hospital Israelita Albert Einstein
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