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

NCT03132597 | Completed

• 1 other identifier: 61240016.3.0000.5133
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

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).

Conditions

Stress; Anxiety; Depression; Quality of Life

Keywords

stress; anxiety; depression; quality of life; Mindfulness

Outcome Measures

Primary Outcomes (3)

• Assess emotional states of depression, anxiety and stress.

  DASS 21 questionnaire application

  At 3 months

• Assess emotional states of depression, anxiety and stress.

  DASS 21 questionnaire application

  At 6 months

• Assess emotional states of depression, anxiety and stress.

  DASS 21 questionnaire application

  At 24 months

Secondary Outcomes (6)

• Assess general facet of "quality of life" and "health"

  At 3 months

• Assess general facet of "quality of life" and "health"

  At 6 months

• Assess general facet of "quality of life" and "health"

  At 24 months

• Evaluation of empathy, spirituality openness and wellness

  At 3 months

• Evaluation of empathy, spirituality openness and wellness

  At 6 months

Study Arms (3)

Early Mindfulness exposure

EXPERIMENTAL

six weeks of 2 hours class of mindfulness training and orientations for home training at the beginning of the first semester

Behavioral: Mindfulness training

Late Mindfulness exposure

EXPERIMENTAL

six weeks of 2 hours class of mindfulness training and orientations for home training at the second half of the first semester

Behavioral: Mindfulness training

Control (not exposed)

NO INTERVENTION

Students not exposed to the mindfulness mandatory course (not exposed to the intervention)

Interventions

Mindfulness training BEHAVIORAL

six weeks of 2 hours class of mindfulness training and orientations for home training

Early Mindfulness exposure; Late Mindfulness exposure

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Students who refused to participate

Sponsors & Collaborators

• Federal University of Juiz de Fora: lead

Study Sites (1)

Federal University of Juiz de Fora

Juiz de Fora, Minas Gerais, 36038330, Brazil

Location

Related Publications (22)

• 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.

  PMID: 23823667 BACKGROUND

• de Vibe M, Solhaug I, Tyssen R, Friborg O, Rosenvinge JH, Sorlie T, Bjorndal 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.

  PMID: 23941053 BACKGROUND

• 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. No abstract available.

  PMID: 24607079 BACKGROUND

• 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.

  PMID: 23837423 BACKGROUND

• 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. doi: 10.1097/00001888-200604000-00009.

  PMID: 16565188 BACKGROUND

• 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.

  PMID: 21099385 BACKGROUND

• 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.

  PMID: 24395196 BACKGROUND

• 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.

  PMID: 25792145 BACKGROUND

• 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. doi: 10.1016/S0022-3999(03)00573-7.

  PMID: 15256293 BACKGROUND

• 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.

  PMID: 19707055 BACKGROUND

• 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.

  PMID: 24016170 BACKGROUND

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

  BACKGROUND

• 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.

  PMID: 25818837 BACKGROUND

• Kuhlmann SM, Burger 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.

  PMID: 25887430 BACKGROUND

• Lamothe M, Rondeau E, 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.

  PMID: 26860797 BACKGROUND

• 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.

  PMID: 24556765 BACKGROUND

• 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.

  PMID: 23126332 BACKGROUND

• 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.

  PMID: 25888726 BACKGROUND

• 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.

  PMID: 21401686 BACKGROUND

• 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.

  PMID: 25034955 BACKGROUND

• Moutinho IL, Maddalena NC, Roland RK, Lucchetti AL, Tibirica 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.

  PMID: 28225885 BACKGROUND

• Damiao Neto A, Lucchetti ALG, da Silva Ezequiel O, Lucchetti G. Effects of a Required Large-Group Mindfulness Meditation Course on First-Year Medical Students' Mental Health and Quality of Life: a Randomized Controlled Trial. J Gen Intern Med. 2020 Mar;35(3):672-678. doi: 10.1007/s11606-019-05284-0. Epub 2019 Aug 26.

  PMID: 31452038 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Oscarina S Ezequiel, MD, PhD

  Federal University of Juiz de Fora

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 20, 2017
• First Posted: April 28, 2017
• Study Start: May 1, 2017
• Primary Completion: July 31, 2018
• Study Completion: December 31, 2018
• Last Updated: February 18, 2019

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)