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Completed

NCT Number: NCT03895190

Effects of a Application (Flourish App) in Medical 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, 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).

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Key information

Age range

17 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Israelita Albert Einstein

São Paulo, 05601-901, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

-

Treatment and study plan

Flourishing App Program

Behavioral

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.

Primary outcomes

  1. Changes in subjective symptoms of well-being at work

    Time frame: baseline, 4 weeks, 8 weeks

    Sliding scale for stress level from 0 to 100

  2. Changes in subjective symptoms of stress

    Time frame: baseline, 4 weeks, 8 weeks

    Sliding scale for well-being level from 0 to 100

Secondary outcomes

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

    Time frame: 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

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

    Sliding scale for well-being level from 0 to 100

Sponsors and collaborators

Lead sponsor

Hospital Israelita Albert Einstein

Other

Registry information

Official study title

Effects of a Application (Flourish App) on Stress, Well-being and Emotional Regulation in Medical Students

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Mar 29, 2019
Registry last updated
Apr 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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