Clinical trial NCT03132597: Impact of Teaching "Meditation Techniques" on the Mental Health and Quality of Life of Medical Students
Official title: Impact of Teaching "Meditation Techniques" on the Mental Health and Quality of Life of Medical Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Anxiety
Depression
Quality of Life
Keywords: stress
anxiety
depression
quality of life
Mindfulness
Lead sponsor: Federal University of Juiz de Fora
Sponsor class: OTHER
First posted: 2017-04-28
Enrollment: 360
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is an intervention protocol using a randomized controlled clinical trial with cross-over, in order to compare if the implementation of mindfulness for first year medical students will improve their mental health and quality of life in the short term (3 months).

The intervention group will be exposed to mindfulness in the beginning of the medical course and will be compared to a control group, not exposed to mindfulness (exposed to theoretical classes) for 3 months. After that, the intervention group will receive theoretical classes and the control group will be exposed to the mindfulness techniques for 3 months (cross-over). Therefore, both groups will be exposed to mindfulness in the first year of undergraduation. Then, all first year medical students exposed to mindfulness will be compared to another class, which didn't have this mindfulness mandatory course in their formation. They will be compared after 6 months and after one-year of intervention (long-term effect).
Primary purpose: PREVENTION

Brief summary: Studies show a high number of medical students suffering from mental health problems. Although there are several studies investigating how these problems could impact students' life and performance, few studies have investigated interventions to minimize this distress. One of these interventions is the mindfulness meditation, that has already been extensively studied in the scientific literature showing promising results. Nevertheless, there are very few studies which investigated how mindfulness could be implemented as a mandatory course. The present study aims to investigate (1) how students exposed to mindfulness differ from students not exposed to this technique concerning their mental health and quality of life in a short and long term period. This is an intervention protocol using a randomized controlled clinical trial with cross-over, in order to compare if the implementation of mindfulness for first year medical students will improve their mental health and quality of life in the short term (3 months). The intervention group (group 1) will be exposed to mindfulness in the beginning of the medical course and will be compared to a control group (group 2), not exposed to mindfulness (exposed to theoretical classes) for 3 months. After that, the intervention group (group 1) will receive theoretical classes and the control group (group 2) will be exposed to the mindfulness techniques for 3 months (cross-over). Therefore, both groups will be exposed to mindfulness in the first year of undergraduation, however in different moments of the course. Then, these first year medical students (groups 1 and 2) will be compared to another class (group 3), which didn't have this mindfulness mandatory course in their formation. They will be compared after 6 months, 12 and 24 months of intervention (long-term effect).

Detailed description: Studies show a high number of medical students suffering from mental health problems. Although there are several studies investigating how these problems could impact students' life and performance, few studies have investigated interventions to minimize this distress. One of these interventions is the mindfulness meditation, that has already been extensively studied in the scientific literature showing promising results. Nevertheless, there are very few studies which investigated how mindfulness could be implemented as a mandatory course. The present study aims to investigate how students exposed to mindfulness differ from students not exposed to this technique concerning their mental health and quality of life in a short and long term period.

Design:

This is an intervention protocol using a randomized controlled clinical trial with cross-over, in order to compare if the implementation of mindfulness for first year medical students will improve their mental health and quality of life in the short term (3 months).

The intervention group (group 1) will be exposed to mindfulness in the beginning of the medical course and will be compared to a control group (group 2), not exposed to mindfulness (exposed to theoretical classes) for 3 months. After that, the intervention group (group 1) will receive theoretical classes and the control group (group 2) will be exposed to the mindfulness techniques for 3 months (cross-over). Therefore, both groups (groups 1 and 2) will be exposed to mindfulness in the first year of undergraduation, however in different moments of the course. Then, all first year medical students exposed to mindfulness (groups 1 and 2) will be compared to another class, which didn't have this mindfulness mandatory course in their formation (group 3). They will be compared after 6 months and after one-year of intervention (long-term effect).

Interventions:

Mindfulness techniques will be delivered to students for a period of six weeks. In these six weeks the following techniques are presented and trained: body scan, mindful eating, breath meditation, listen mindfully, walking meditation, mountain meditation, compassion meditation, observation thoughts as just thoughts, awareness with listing of daily activities, mindful breath mini-breaks and some breath exercises.

Theoretical classes will provide tools in order to help students to deal with their medical school entrance, including how the medical school and the university works (library, evaluations, being a doctor, scholarships and student aid work, among others) and what students should know about their career as future physicians.

Procedures:

Students will answer the questionnaire in the following way:

* Intervention Group: before intervention (baseline), after intervention (3 months), after cross-over (6 months), 12 months and 24 months.
* Control Group: before intervention (baseline), before intervention (3 months), after intervention - cross over (6 months), 12 months and 24 months.
* Class not exposed to mindfulness mandatory course: 12 months and 24 months

Instruments:

The following instruments will be used:

* DASS-21: Depression, anxiety and stress scale
* Quality of Life: WHOQOL-Bref scale
* FFMQ: Five facet mindfulness questionnaire
* Sociodemographic data

Statistical analysis:

Students will be compared in the following way:

1. Students exposed to mindfulness versus students not exposed = short term period (3 months)
2. Students with an early exposition to mindfulness in the first year versus students with a later exposition = short term period (6 months)
3. Students exposed to a mandatory course on mindfulness versus students not exposed to this course = long term period (12 and 24 months)

Eligibility criteria: Inclusion Criteria:

* First year medical students who agree to participate in the study and are officially registered in the mindfulness course at the school of medicine - Federal University of Juiz de Fora, Brazil

Exclusion criteria:

* Students who refused to participate

Primary outcomes:
measure: Assess emotional states of depression, anxiety and stress.
timeFrame: At 3 months
measure: Assess emotional states of depression, anxiety and stress.
timeFrame: At 6 months
measure: Assess emotional states of depression, anxiety and stress.
timeFrame: At 24 months
Secondary outcomes:
measure: Assess general facet of "quality of life" and "health"
timeFrame: At 3 months
measure: Assess general facet of "quality of life" and "health"
timeFrame: At 6 months
measure: Assess general facet of "quality of life" and "health"
timeFrame: At 24 months
measure: Evaluation of empathy, spirituality openness and wellness
timeFrame: At 3 months
measure: Evaluation of empathy, spirituality openness and wellness
timeFrame: At 6 months
measure: Evaluation of empathy, spirituality openness and wellness
timeFrame: At 24 months
Other outcomes:
Locations:
city: Juiz de Fora
country: Brazil
facility: Federal University of Juiz de Fora
state: Minas Gerais
Study officials:
affiliation: Federal University of Juiz de Fora
name: Oscarina S Ezequiel, MD, PhD
role: STUDY_CHAIR
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