Effects of a Application (Flourish App) in Medical Students

Sponsor
Hospital Israelita Albert Einstein (Other)
Overall Status
Completed
CT.gov ID
NCT03895190
Collaborator
(none)
50
1
2
8.5
5.9

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Flourishing App Program
N/A

Detailed Description

INTRODUCTION: One population that presents an important vulnerability to stress is that of university students, facing several stressors, such as academic demands, time pressure and social adjustments. Medical students in particular may face additional challenges such as heavy workload, time commitment and the number of tests and assessments as well as the pressures of a clinical setting. Some highly successful programs in stress management are based on the principle of Mindfulness. On the other hand, Positive Psychology brings a new paradigm in terms of mental and emotional health, seeking to promote human development through the development of virtues, quality of life and well-being, instead of just treating disease. In the modern world not all people are willing to attend classroom training for several reasons. In this sense, a program offered in mobile application can be considered an interesting alternative for professionals that not only want to reduce stress-related symptoms, but also promote well-being.

MAIN OBJECTIVES: Evaluate the effects of a well-being program compared to a control program, both served on mobile applications, in reducing stress, increasing well-being and improving emotional regulation in a sample of medical students.

METHOD: For this purpose, 300 students of the undergraduate medical course of Albert Einstein Israelite Faculty. Participants will be randomized into groups of 150 each, half to the control group (CG) and the other half to the intervention group (IG). The IG will participate in the Flourish App Program, for 8 weeks, while the CG will have access to a control application. Then, after the evaluations, the CG will participate in the Flourish App Program, while the first group will not participate in any intervention. Before starting the program, after 4 and 8 weeks of the program, questions will be applied to assess the stress and well-being levels of participants in general and in relation to work. In addition, before and after each training period, questions will be applied to assess the stress and well-being levels of participants at the moment. Also, the Perceived Stress Scale, the 5-item World Health Organization Well-Being Index - WHO-5, the Mindful Attention Awareness Scale, the Self-Compassion Scale and the Difficulties in Emotion Regulation Scale will be applied too. Finally, at the end of the program, the Mobile Application Rating Scale - MARS will be applied.

Study Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Effects of a Application (Flourish App) on Stress, Well-being and Emotional Regulation in Medical Students
Actual Study Start Date :
Aug 6, 2019
Actual Primary Completion Date :
Sep 1, 2019
Actual Study Completion Date :
Apr 21, 2020

Arms and Interventions

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: Experimental: Flourishing App Program

This group will receive the intervention Flourishing App Program and after that it will not receive any other 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 8 weeks, with trainings of 15 to 25 minutes, four times a week.

Outcome Measures

Primary Outcome Measures

  1. Changes in subjective symptoms of well-being at work [baseline, 4 weeks, 8 weeks]

    Sliding scale for stress level from 0 to 100

  2. Changes in subjective symptoms of stress [baseline, 4 weeks, 8 weeks]

    Sliding scale for well-being level from 0 to 100

Secondary Outcome Measures

  1. 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)]

    Sliding scale for stress level from 0 to 100

  2. 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)]

    Sliding scale for well-being level from 0 to 100

Eligibility Criteria

Criteria

Ages Eligible for Study:
17 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Women and men from 17 years

  • Students of the undergraduate medical course of Albert Einstein Israelite Faculty

Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Israelita Albert Einstein São Paulo SP Brazil 05601-901

Sponsors and Collaborators

  • Hospital Israelita Albert Einstein

Investigators

  • Principal Investigator: Elisa H Kozasa, PhD, Instituto do Cérebro- Hospital Israelita Albert Einstein

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hospital Israelita Albert Einstein
ClinicalTrials.gov Identifier:
NCT03895190
Other Study ID Numbers:
  • HIAE_Florescer_Medicina
First Posted:
Mar 29, 2019
Last Update Posted:
Apr 24, 2020
Last Verified:
Mar 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Hospital Israelita Albert Einstein

Study Results

No Results Posted as of Apr 24, 2020