Impact of Teaching "Meditation Techniques" on the Mental Health and Quality of Life of Medical Students

Depression Clinical Trial

Official title:

Impact of Teaching "Meditation Techniques" on the Mental Health and Quality of Life of Medical Students

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03132597
• Other study ID #: 61240016.3.0000.5133
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: December 31, 2018

Study information

• Verified date: August 2018
• Source: Federal University of Juiz de Fora
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: December 31, 2018
• Est. primary completion date: July 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Quality of Life
• Stress

Intervention

Behavioral:
• Mindfulness training
six weeks of 2 hours class of mindfulness training and orientations for home training

Locations

Country	Name	City	State
Brazil	Federal University of Juiz de Fora	Juiz de Fora	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Juiz de Fora

Country where clinical trial is conducted

Brazil, 

References & Publications (21)

Barbosa P, Raymond G, Zlotnick C, Wilk J, Toomey R 3rd, Mitchell J 3rd. Mindfulness-based stress reduction training is associated with greater empathy and reduced anxiety for graduate healthcare students. Educ Health (Abingdon). 2013 Jan-Apr;26(1):9-14. doi: 10.4103/1357-6283.112794. — View Citation

de Vibe M, Solhaug I, Tyssen R, Friborg O, Rosenvinge JH, Sørlie T, Bjørndal A. Mindfulness training for stress management: a randomised controlled study of medical and psychology students. BMC Med Educ. 2013 Aug 13;13:107. doi: 10.1186/1472-6920-13-107. — View Citation

Demarzo MM, Andreoni S, Sanches N, Perez S, Fortes S, Garcia-Campayo J. Mindfulness-based stress reduction (MBSR) in perceived stress and quality of life: an open, uncontrolled study in a Brazilian healthy sample. Explore (NY). 2014 Mar-Apr;10(2):118-20. doi: 10.1016/j.explore.2013.12.005. Epub 2013 Dec 18. — View Citation

Dobkin PL, Hutchinson TA. Teaching mindfulness in medical school: where are we now and where are we going? Med Educ. 2013 Aug;47(8):768-79. doi: 10.1111/medu.12200. Review. — View Citation

Dyrbye LN, Thomas MR, Shanafelt TD. Systematic review of depression, anxiety, and other indicators of psychological distress among U.S. and Canadian medical students. Acad Med. 2006 Apr;81(4):354-73. Review. — View Citation

Ghodasara SL, Davidson MA, Reich MS, Savoie CV, Rodgers SM. Assessing student mental health at the Vanderbilt University School of Medicine. Acad Med. 2011 Jan;86(1):116-21. doi: 10.1097/ACM.0b013e3181ffb056. — View Citation

Goyal M, Singh S, Sibinga EM, Gould NF, Rowland-Seymour A, Sharma R, Berger Z, Sleicher D, Maron DD, Shihab HM, Ranasinghe PD, Linn S, Saha S, Bass EB, Haythornthwaite JA. Meditation programs for psychological stress and well-being: a systematic review and meta-analysis. JAMA Intern Med. 2014 Mar;174(3):357-68. doi: 10.1001/jamainternmed.2013.13018. Review. — View Citation

Greeson JM, Toohey MJ, Pearce MJ. An adapted, four-week mind-body skills group for medical students: reducing stress, increasing mindfulness, and enhancing self-care. Explore (NY). 2015 May-Jun;11(3):186-92. doi: 10.1016/j.explore.2015.02.003. Epub 2015 Feb 16. — View Citation

Grossman P, Niemann L, Schmidt S, Walach H. Mindfulness-based stress reduction and health benefits. A meta-analysis. J Psychosom Res. 2004 Jul;57(1):35-43. — View Citation

Hojat M, Vergare MJ, Maxwell K, Brainard G, Herrine SK, Isenberg GA, Veloski J, Gonnella JS. The devil is in the third year: a longitudinal study of erosion of empathy in medical school. Acad Med. 2009 Sep;84(9):1182-91. doi: 10.1097/ACM.0b013e3181b17e55. Erratum in: Acad Med. 2009 Nov;84(11):1616. — View Citation

Jamali A, Tofangchiha S, Jamali R, Nedjat S, Jan D, Narimani A, Montazeri A. Medical students' health-related quality of life: roles of social and behavioural factors. Med Educ. 2013 Oct;47(10):1001-12. doi: 10.1111/medu.12247. — View Citation

KABAT-ZINN, J. Full catastrophe living: Using the wisdom of your body and mind to face stress, pain and illness. New York: Delacorte, 1990.

Khoury B, Sharma M, Rush SE, Fournier C. Mindfulness-based stress reduction for healthy individuals: A meta-analysis. J Psychosom Res. 2015 Jun;78(6):519-28. doi: 10.1016/j.jpsychores.2015.03.009. Epub 2015 Mar 20. Review. — View Citation

Kuhlmann SM, Bürger A, Esser G, Hammerle F. A mindfulness-based stress prevention training for medical students (MediMind): study protocol for a randomized controlled trial. Trials. 2015 Feb 8;16:40. doi: 10.1186/s13063-014-0533-9. — View Citation

Lamothe M, Rondeau É, Malboeuf-Hurtubise C, Duval M, Sultan S. Outcomes of MBSR or MBSR-based interventions in health care providers: A systematic review with a focus on empathy and emotional competencies. Complement Ther Med. 2016 Feb;24:19-28. doi: 10.1016/j.ctim.2015.11.001. Epub 2015 Nov 27. Review. — View Citation

Moutinho IL, Maddalena NC, Roland RK, Lucchetti AL, Tibiriçá SH, Ezequiel OD, Lucchetti G. Depression, stress and anxiety in medical students: A cross-sectional comparison between students from different semesters. Rev Assoc Med Bras (1992). 2017 Jan 1;63(1):21-28. doi: 10.1590/1806-9282.63.01.21. — View Citation

Slavin SJ, Schindler DL, Chibnall JT. Medical student mental health 3.0: improving student wellness through curricular changes. Acad Med. 2014 Apr;89(4):573-7. doi: 10.1097/ACM.0000000000000166. Review. — View Citation

Tempski P, Bellodi PL, Paro HB, Enns SC, Martins MA, Schraiber LB. What do medical students think about their quality of life? A qualitative study. BMC Med Educ. 2012 Nov 5;12:106. doi: 10.1186/1472-6920-12-106. — View Citation

van Dijk I, Lucassen PL, Speckens AE. Mindfulness training for medical students in their clinical clerkships: two cross-sectional studies exploring interest and participation. BMC Med Educ. 2015 Feb 25;15:24. doi: 10.1186/s12909-015-0302-9. — View Citation

Warnecke E, Quinn S, Ogden K, Towle N, Nelson MR. A randomised controlled trial of the effects of mindfulness practice on medical student stress levels. Med Educ. 2011 Apr;45(4):381-8. doi: 10.1111/j.1365-2923.2010.03877.x. — View Citation

Williams D, Tricomi G, Gupta J, Janise A. Efficacy of burnout interventions in the medical education pipeline. Acad Psychiatry. 2015 Feb;39(1):47-54. doi: 10.1007/s40596-014-0197-5. Epub 2014 Jul 18. Review. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess emotional states of depression, anxiety and stress.	DASS 21 questionnaire application	At 3 months
Primary	Assess emotional states of depression, anxiety and stress.	DASS 21 questionnaire application	At 6 months
Primary	Assess emotional states of depression, anxiety and stress.	DASS 21 questionnaire application	At 24 months
Secondary	Assess general facet of "quality of life" and "health"	WHOQOL-BREF questionnaire application	At 3 months
Secondary	Assess general facet of "quality of life" and "health"	WHOQOL-BREF questionnaire application	At 6 months
Secondary	Assess general facet of "quality of life" and "health"	WHOQOL-BREF questionnaire application	At 24 months
Secondary	Evaluation of empathy, spirituality openness and wellness	ESWIM questionnaire application	At 3 months
Secondary	Evaluation of empathy, spirituality openness and wellness	ESWIM questionnaire application	At 6 months
Secondary	Evaluation of empathy, spirituality openness and wellness	ESWIM questionnaire application	At 24 months