StressNCT03132597
Impact of Teaching "Meditation Techniques" on the Mental Health and Quality of Life of Medical Students
A study testing Mindfulness training in people with Stress and Anxiety, run by Federal University of Juiz de Fora at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stress, Anxiety, Depression
- What is being tested?
- Mindfulness training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteBrazil
- Study dates
- 1 May 2017to 31 Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Students who refused to participate
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Juiz de Fora
Juiz de Fora, Minas Gerais, 36038330
About this study
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).
Read the 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:
- Students exposed to mindfulness versus students not exposed = short term period (3 months)
- Students with an early exposition to mindfulness in the first year versus students with a later exposition = short term period (6 months)
- Students exposed to a mandatory course on mindfulness versus students not exposed to this course = long term period (12 and 24 months)
- Conditions
- Stress, Anxiety, Depression, Quality of Life
- Being tested
- Mindfulness training
- Keywords
- stress, anxiety, depression, quality of life, Mindfulness
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness trainingBehavioural
six weeks of 2 hours class of mindfulness training and orientations for home training
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Mindfulness training |
| Control (not exposed) | No intervention | Students not exposed to the mindfulness mandatory course (not exposed to the intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess emotional states of depression, anxiety and stress.
DASS 21 questionnaire application
Measured: At 3 months
Assess emotional states of depression, anxiety and stress.
DASS 21 questionnaire application
Measured: At 6 months
Assess emotional states of depression, anxiety and stress.
DASS 21 questionnaire application
Measured: At 24 months
Secondary outcomes (6)
Assess general facet of "quality of life" and "health"
WHOQOL-BREF questionnaire application
Measured: At 3 months
Assess general facet of "quality of life" and "health"
WHOQOL-BREF questionnaire application
Measured: At 6 months
Assess general facet of "quality of life" and "health"
WHOQOL-BREF questionnaire application
Measured: At 24 months
Evaluation of empathy, spirituality openness and wellness
ESWIM questionnaire application
Measured: At 3 months
Evaluation of empathy, spirituality openness and wellness
ESWIM questionnaire application
Measured: At 6 months
Evaluation of empathy, spirituality openness and wellness
ESWIM questionnaire application
Measured: At 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start1 May 2017
- Primary completion31 Jul 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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).
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Juiz de Fora
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oscarina S Ezequiel, MD, PhD, Study chair, Federal University of Juiz de Fora
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03132597
- Sponsor's protocol ID
- 61240016.3.0000.5133
- Status last verified
- Aug 2018
- First submitted
- 20 Apr 2017
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23823667de 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.
PubMed 23941053Demarzo 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.
PubMed 24607079Dobkin 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.
PubMed 23837423Dyrbye 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.
PubMed 16565188Ghodasara 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.
PubMed 21099385Goyal 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.
PubMed 24395196Greeson 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.
PubMed 25792145Grossman 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.
PubMed 15256293Hojat 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.
PubMed 19707055Jamali 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.
PubMed 24016170KABAT-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.
PubMed 25818837Kuhlmann 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.
PubMed 25887430Lamothe 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.
PubMed 26860797
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Teaching "Meditation Techniques" on the Mental Health and Quality of Life of Medical Students
- ClinicalTrials.gov ID
- NCT03132597
- Acronym / sponsor ID
- 61240016.3.0000.5133
- Conditions
- Stress, Anxiety, Depression, Quality of Life
- Keywords
- stress, anxiety, depression, quality of life, Mindfulness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Federal University of Juiz de ForaUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 Jul 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 28 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Students exposed to mindfulness versus students not exposed = short term period (3 months)
- Students with an early exposition to mindfulness in the first year versus students with a later exposition = short term period (6 months)
- Students exposed to a mandatory course on mindfulness versus students not exposed to this course = long term period (12 and 24 months)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- 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).
| Arm | Type | Receives |
|---|---|---|
| Early Mindfulness exposure | Experimental | Behavioral: Mindfulness trainingsix weeks of 2 hours class of mindfulness training and orientations for home training at the beginning of the first semester |
| Late Mindfulness exposure | Experimental | Behavioral: Mindfulness trainingsix weeks of 2 hours class of mindfulness training and orientations for home training at the second half of the first semester |
| Control (not exposed) | No intervention | –Students not exposed to the mindfulness mandatory course (not exposed to the intervention) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Students who refused to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness trainingsix weeks of 2 hours class of mindfulness training and orientations for home training | Behavioural | Early Mindfulness exposure, Late Mindfulness exposure |
Primary outcome
Assess emotional states of depression, anxiety and stress.
Time frame: At 3 months
DASS 21 questionnaire application
Assess emotional states of depression, anxiety and stress.
Time frame: At 6 months
DASS 21 questionnaire application
Assess emotional states of depression, anxiety and stress.
Time frame: At 24 months
DASS 21 questionnaire application
6 secondary outcomes
Assess general facet of "quality of life" and "health"
Time frame: At 3 months
Assess general facet of "quality of life" and "health"
Time frame: At 6 months
Assess general facet of "quality of life" and "health"
Time frame: At 24 months
Evaluation of empathy, spirituality openness and wellness
Time frame: At 3 months
Evaluation of empathy, spirituality openness and wellness
Time frame: At 6 months
Evaluation of empathy, spirituality openness and wellness
Time frame: At 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2019.
- Background: PubMed 23823667Barbosa 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.
- Background: PubMed 23941053de 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.
- Background: PubMed 24607079Demarzo 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.
- Background: PubMed 23837423Dobkin 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.
- Background: PubMed 16565188Dyrbye 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.
- Background: PubMed 21099385Ghodasara 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.
- Background: PubMed 24395196Goyal 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.
- Background: PubMed 25792145Greeson 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.
- Background: PubMed 15256293Grossman 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.
- Background: PubMed 19707055Hojat 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.
- Background: PubMed 24016170Jamali 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.
- BackgroundKABAT-ZINN, J. Full catastrophe living: Using the wisdom of your body and mind to face stress, pain and illness. New York: Delacorte, 1990.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oscarina S Ezequiel, MD, PhD study chair
Federal University of Juiz de Fora
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness training in people with Stress and Anxiety, run by Federal University of Juiz de Fora at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess emotional states of depression, anxiety and stress. (time frame: At 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03132597, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2019.