BurnoutMIIBNCT05013489
Mindfulness and Intercare Based Intervention for Physicians Burnout Reduction
A study testing Mindfulness and intercare based intervention in people with Burnout and Mental Health Wellness 1, run by University Diego Portales at 1 site in Chile.
Trial summary
During the coronavirus disease 2019 (COVID19) pandemic, many physicians have presented burnout. A range of associated factors need to be considered for effective prevention and intervention. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burnout, Mental Health Wellness 1
- What is being tested?
- Mindfulness and intercare based intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 795 participants
- Where
- 1 siteChile
- Study dates
- 30 Oct 2020to 30 Sep 2021
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Physicians enrolled in the database of the medical college of Chile
Who cannot join
- Recent Grief
- Severe acute depression disorder
- Active suicidal ideation
- Active Psychosis
- Active addiction
- Post Traumatic Stres Disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Physicians Burnout: Cause, Consequence and Mindfulness and Intercare Based Intervention for Physicians Burnout Reduction
During the coronavirus disease 2019 (COVID19) pandemic, many physicians have presented burnout. A range of associated factors need to be considered for effective prevention and intervention. Objective 1: To assess the association of burnout in medical doctors with individual factors, self-reported medical errors, medical leave, and demands of the work environment demand. Objective 2: to assess the effectiveness of a online mindfulness, compassion and intercare based intervention to reduce burnout.
- Conditions
- Burnout, Mental Health Wellness 1
- Being tested
- Mindfulness and intercare based intervention
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness and intercare based interventionBehavioural
Eight week online program based on mindfulness, compassion and intercare intervention. A two hour synchronic online session every week plus daily homework based on meditation and journaling exercises.
The topics covered in the program are mindfulness meditation, cognitive behavioral therapy exercises, gratitude and acceptance, compassion and self compassion exercises, conservation of resources theory and intercare.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness, compassion and intercare based Intervention | Experimental | An Eight week mindfulness and intercare group online program. Receives: Behavioral: Mindfulness and intercare based intervention |
| Waiting list | No intervention | Psychological support if needed. No other intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maslach Burnout Inventory - Human Services
Burnout was evaluated with Maslach Burnout Inventory for Human Services. Continuous variable for burnout total score, emotional exhaustion, depersonalization and accomplishment. Dichotomous variable was used for burnout syndrome using two common cut-off point criteria and a new proposal.
Measured: Baseline
Maslach Burnout Inventory - Human Services
Burnout was evaluated with Maslach Burnout Inventory for Human Services. Continuous variable for burnout total score, emotional exhaustion, depersonalization and accomplishment. Dichotomous variable was used for burnout syndrome using two common cut-off point criteria and a new proposal.
Measured: 3 months
Maslach Burnout Inventory - Human Services
Burnout was evaluated with Maslach Burnout Inventory for Human Services. Continuous variable for burnout total score, emotional exhaustion, depersonalization and accomplishment. Dichotomous variable was used for burnout syndrome using two common cut-off point criteria and a new proposal.
Measured: 6 months
Secondary outcomes (19)
Demands of the work environment - Psychosocial Factors Questionnaire 75. (PFQ-75-SF)
Demands of the work environment were evaluated with an adaptation of the Psychosocial Factors Questionnaire 75.
Measured: Baseline
Demands of the work environment - Psychosocial Factors Questionnaire 75. (PFQ-75-SF)
Demands of the work environment were evaluated with an adaptation of the Psychosocial Factors Questionnaire 75.
Measured: 3 months
Demands of the work environment - Psychosocial Factors Questionnaire 75. (PFQ-75-SF)
Demands of the work environment were evaluated with an adaptation of the Psychosocial Factors Questionnaire 75.
Measured: 6 months
Medical error perception - Medical Error Checklist General (MECG)
Medical error perception was evaluated with an adaptation of the Medical Error Checklist.
Measured: Baseline
Medical error perception - Medical Error Checklist General (MECG)
Medical error perception was evaluated with an adaptation of the Medical Error Checklist.
Measured: 3 months
Medical error perception - Medical Error Checklist General (MECG)
Medical error perception was evaluated with an adaptation of the Medical Error Checklist.
Measured: 6 months
Medical Leave
Days of medical leave if needed
Measured: Baseline
Medical Leave
Days of medical leave if needed
Measured: 3 months
Medical Leave
Days of medical leave if needed
Measured: 6 months
Personality - The Big Five Inventory-2 Short Form (BFI-2-S)
As individual factors were measured Personality with a short version of the Big Five Questionnaire The Big Five Inventory-2 Short Form (BFI-2-S)
Measured: Baseline
Mental Health - Mental Health Continuum Scale- Short Form
Mental Health - Mental Health Continuum Scale- Short Form (MHC-14): Mental health can be defined as a state in which an individual realizes his or her own abilities, can cope with the stresses of life, can work productively and can make a contribution,and is described by Corey L. Keyes in 3 main dimensions; emotional well being, psychological well being and social well being.
It is a Likert from 0 to 5 with a total of 14 ítems and 3 main subdimensions: emotional well being (BE, 3 ítems), psychological well being (BP, 5 ítems) y social well being.(PS, 6 ítems). It as a total score of 70 and a minium of 0. The higher the better mental health.
Measured: Baseline
Mental Health - Mental Health Continuum Scale- Short Form
Mental Health - Mental Health Continuum Scale- Short Form (MHC-14): Mental health can be defined as a state in which an individual realizes his or her own abilities, can cope with the stresses of life, can work productively and can make a contribution,and is described by Corey L. Keyes in 3 main dimensions; emotional well being, psychological well being and social well being.
It is a Likert from 0 to 5 with a total of 14 ítems and 3 main subdimensions: emotional well being (BE, 3 ítems), psychological well being (BP, 5 ítems) y social well being.(PS, 6 ítems). It as a total score of 70 and a minium of 0. The higher the better mental health.
Measured: 3 months
Mental Health - Mental Health Continuum Scale- Short Form
Mental Health - Mental Health Continuum Scale- Short Form (MHC-14): Mental health can be defined as a state in which an individual realizes his or her own abilities, can cope with the stresses of life, can work productively and can make a contribution,and is described by Corey L. Keyes in 3 main dimensions; emotional well being, psychological well being and social well being.
It is a Likert from 0 to 5 with a total of 14 ítems and 3 main subdimensions: emotional well being (BE, 3 ítems), psychological well being (BP, 5 ítems) y social well being.(PS, 6 ítems). It as a total score of 70 and a minium of 0. The higher the better mental health.
Measured: 6 months
Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF)
Mindfulness is defined as the ability to pay attention to our own experiences without judging them. The Five Facet Mindfulness Questionnaire Short Form was used, which consists of 24 questions that look for the 5 facets of mindfulness: observe, describe, act aware, non-judge and no-react.
Measured: Baseline
Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF)
Mindfulness is defined as the ability to pay attention to our own experiences without judging them. The Five Facet Mindfulness Questionnaire Short Form was used, which consists of 24 questions that look for the 5 facets of mindfulness: observe, describe, act aware, non-judge and no-react.
Measured: 3 months
Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF)
Mindfulness is defined as the ability to pay attention to our own experiences without judging them. The Five Facet Mindfulness Questionnaire Short Form was used, which consists of 24 questions that look for the 5 facets of mindfulness: observe, describe, act aware, non-judge and no-react.
Measured: 6 months
Self compassion scale Short form (SCS-SF)
Self compassion is understood as maintenance of full attention and opening without disconnecting from self's suffering with the desire to alleviate it in a non judgemental way, comprehending the own experience as a part of the human experience. The "Self Compassion Scale Short Form - 12 a scale of 6 sub domains was used.
Measured: Baseline
Self compassion scale Short form (SCS-SF)
Self compassion is understood as maintenance of full attention and opening without disconnecting from self's suffering with the desire to alleviate it in a non judgemental way, comprehending the own experience as a part of the human experience. The "Self Compassion Scale Short Form - 12 a scale of 6 sub domains was used.
Measured: 3 months
Self compassion scale Short form (SCS-SF)
Self compassion is understood as maintenance of full attention and opening without disconnecting from self's suffering with the desire to alleviate it in a non judgemental way, comprehending the own experience as a part of the human experience. The "Self Compassion Scale Short Form - 12 a scale of 6 sub domains was used.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2021
- Study start30 Oct 2020
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BurnoutStudies 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 795 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Diego Portales
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Francisco Javier Villalon Lopez, University Diego Portales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05013489
- Sponsor's protocol ID
- 17-2020
- Acronym
- MIIB
- Status last verified
- May 2022
- First submitted
- 12 Aug 2021
- Last updated
- 20 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Villalon Lopez F, Mundt AP, Hirmas A, Rivera RM, Guiloff R. Impact of burnout on turnover, medical errors, medical leave and a cross-sectional study of contributing factors among Chilean physicians. BMJ Open. 2025 May 15;15(5):e099773. doi: 10.1136/bmjopen-2025-099773.
PubMed 40379332
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physicians Burnout: Cause, Consequence and Mindfulness and Intercare Based Intervention for Physicians Burnout Reduction
- ClinicalTrials.gov ID
- NCT05013489
- Acronym / sponsor ID
- MIIB / 17-2020
- Conditions
- Burnout, Mental Health Wellness 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 795 participants (actual)
- Lead sponsor
- University Diego PortalesUniversity, hospital or other
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 19 Aug 2021 (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.
During the coronavirus disease 2019 (COVID19) pandemic, many physicians have presented burnout. A range of associated factors need to be considered for effective prevention and intervention. Objective 1: To assess the association of burnout in medical doctors with individual factors, self-reported medical errors, medical leave, and demands of the work environment demand. Objective 2: to assess the effectiveness of a online mindfulness, compassion and intercare based intervention to reduce burnout.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness, compassion and intercare based Intervention | Experimental | Behavioral: Mindfulness and intercare based interventionAn Eight week mindfulness and intercare group online program. |
| Waiting list | No intervention | –Psychological support if needed. No other intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Physicians enrolled in the database of the medical college of Chile
Key exclusion criteria (6 listed)
- Recent Grief
- Severe acute depression disorder
- Active suicidal ideation
- Active Psychosis
- Active addiction
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 and intercare based interventionEight week online program based on mindfulness, compassion and intercare intervention. A two hour synchronic online session every week plus daily homework based on meditation and journaling exercises. The topics covered in the program are mindfulness meditation, cognitive behavioral therapy exercises, gratitude and acceptance, compassion and self compassion exercises, conservation of resources theory and intercare. | Behavioural | Mindfulness, compassion and intercare based Intervention |
Primary outcome
Maslach Burnout Inventory - Human Services
Time frame: Baseline
Burnout was evaluated with Maslach Burnout Inventory for Human Services. Continuous variable for burnout total score, emotional exhaustion, depersonalization and accomplishment. Dichotomous variable was used for burnout syndrome using two common cut-off point criteria and a new proposal.
Maslach Burnout Inventory - Human Services
Time frame: 3 months
Burnout was evaluated with Maslach Burnout Inventory for Human Services. Continuous variable for burnout total score, emotional exhaustion, depersonalization and accomplishment. Dichotomous variable was used for burnout syndrome using two common cut-off point criteria and a new proposal.
Maslach Burnout Inventory - Human Services
Time frame: 6 months
Burnout was evaluated with Maslach Burnout Inventory for Human Services. Continuous variable for burnout total score, emotional exhaustion, depersonalization and accomplishment. Dichotomous variable was used for burnout syndrome using two common cut-off point criteria and a new proposal.
19 secondary outcomes
Demands of the work environment - Psychosocial Factors Questionnaire 75. (PFQ-75-SF)
Time frame: Baseline
Demands of the work environment - Psychosocial Factors Questionnaire 75. (PFQ-75-SF)
Time frame: 3 months
Demands of the work environment - Psychosocial Factors Questionnaire 75. (PFQ-75-SF)
Time frame: 6 months
Medical error perception - Medical Error Checklist General (MECG)
Time frame: Baseline
Medical error perception - Medical Error Checklist General (MECG)
Time frame: 3 months
Medical error perception - Medical Error Checklist General (MECG)
Time frame: 6 months
Medical Leave
Time frame: Baseline
Medical Leave
Time frame: 3 months
Medical Leave
Time frame: 6 months
Personality - The Big Five Inventory-2 Short Form (BFI-2-S)
Time frame: Baseline
Mental Health - Mental Health Continuum Scale- Short Form
Time frame: Baseline
Mental Health - Mental Health Continuum Scale- Short Form
Time frame: 3 months
Mental Health - Mental Health Continuum Scale- Short Form
Time frame: 6 months
Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF)
Time frame: Baseline
Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF)
Time frame: 3 months
Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF)
Time frame: 6 months
Self compassion scale Short form (SCS-SF)
Time frame: Baseline
Self compassion scale Short form (SCS-SF)
Time frame: 3 months
Self compassion scale Short form (SCS-SF)
Time frame: 6 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 20 May 2022.
- Derived from this study: PubMed 40379332Villalon Lopez F, Mundt AP, Hirmas A, Rivera RM, Guiloff R. Impact of burnout on turnover, medical errors, medical leave and a cross-sectional study of contributing factors among Chilean physicians. BMJ Open. 2025 May 15;15(5):e099773. doi: 10.1136/bmjopen-2025-099773.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and intercare based intervention in people with Burnout and Mental Health Wellness 1, run by University Diego Portales at 1 site in Chile.
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 6 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 20 May 2022. 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 Chile. 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?
Maslach Burnout Inventory - Human Services (time frame: Baseline). 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 NCT05013489, which also lists 1 linked publication.
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 20 May 2022.