Mindfulness and Intercare Based Intervention for Physicians Burnout Reduction (MIIB)
Primary Purpose
Burnout, Mental Health Wellness 1
Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Mindfulness and intercare based intervention
Sponsored by
About this trial
This is an interventional prevention trial for Burnout
Eligibility Criteria
Inclusion Criteria:
- Physicians enrolled in the database of the medical college of Chile
Exclusion Criteria:
- Recent Grief
- Severe acute depression disorder
- Active suicidal ideation
- Active Psychosis
- Active addiction
- Post Traumatic Stres Disorder
Sites / Locations
- University Diego Portales
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Mindfulness, compassion and intercare based Intervention
Waiting list
Arm Description
An Eight week mindfulness and intercare group online program.
Psychological support if needed. No other intervention.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
Medical error perception - Medical Error Checklist General (MECG)
Medical error perception was evaluated with an adaptation of the Medical Error Checklist.
Medical error perception - Medical Error Checklist General (MECG)
Medical error perception was evaluated with an adaptation of the Medical Error Checklist.
Medical error perception - Medical Error Checklist General (MECG)
Medical error perception was evaluated with an adaptation of the Medical Error Checklist.
Medical Leave
Days of medical leave if needed
Medical Leave
Days of medical leave if needed
Medical Leave
Days of medical leave if needed
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)
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05013489
First Posted
August 12, 2021
Last Updated
May 16, 2022
Sponsor
University Diego Portales
1. Study Identification
Unique Protocol Identification Number
NCT05013489
Brief Title
Mindfulness and Intercare Based Intervention for Physicians Burnout Reduction
Acronym
MIIB
Official Title
Physicians Burnout: Cause, Consequence and Mindfulness and Intercare Based Intervention for Physicians Burnout Reduction
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 30, 2020 (Actual)
Primary Completion Date
September 30, 2021 (Actual)
Study Completion Date
September 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Diego Portales
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burnout, Mental Health Wellness 1
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
795 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mindfulness, compassion and intercare based Intervention
Arm Type
Experimental
Arm Description
An Eight week mindfulness and intercare group online program.
Arm Title
Waiting list
Arm Type
No Intervention
Arm Description
Psychological support if needed. No other intervention.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness and intercare based intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Maslach Burnout Inventory - Human Services
Description
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.
Time Frame
Baseline
Title
Maslach Burnout Inventory - Human Services
Description
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.
Time Frame
3 months
Title
Maslach Burnout Inventory - Human Services
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Demands of the work environment - Psychosocial Factors Questionnaire 75. (PFQ-75-SF)
Description
Demands of the work environment were evaluated with an adaptation of the Psychosocial Factors Questionnaire 75.
Time Frame
Baseline
Title
Demands of the work environment - Psychosocial Factors Questionnaire 75. (PFQ-75-SF)
Description
Demands of the work environment were evaluated with an adaptation of the Psychosocial Factors Questionnaire 75.
Time Frame
3 months
Title
Demands of the work environment - Psychosocial Factors Questionnaire 75. (PFQ-75-SF)
Description
Demands of the work environment were evaluated with an adaptation of the Psychosocial Factors Questionnaire 75.
Time Frame
6 months
Title
Medical error perception - Medical Error Checklist General (MECG)
Description
Medical error perception was evaluated with an adaptation of the Medical Error Checklist.
Time Frame
Baseline
Title
Medical error perception - Medical Error Checklist General (MECG)
Description
Medical error perception was evaluated with an adaptation of the Medical Error Checklist.
Time Frame
3 months
Title
Medical error perception - Medical Error Checklist General (MECG)
Description
Medical error perception was evaluated with an adaptation of the Medical Error Checklist.
Time Frame
6 months
Title
Medical Leave
Description
Days of medical leave if needed
Time Frame
Baseline
Title
Medical Leave
Description
Days of medical leave if needed
Time Frame
3 months
Title
Medical Leave
Description
Days of medical leave if needed
Time Frame
6 months
Title
Personality - The Big Five Inventory-2 Short Form (BFI-2-S)
Description
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)
Time Frame
Baseline
Title
Mental Health - Mental Health Continuum Scale- Short Form
Description
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.
Time Frame
Baseline
Title
Mental Health - Mental Health Continuum Scale- Short Form
Description
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.
Time Frame
3 months
Title
Mental Health - Mental Health Continuum Scale- Short Form
Description
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.
Time Frame
6 months
Title
Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF)
Description
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.
Time Frame
Baseline
Title
Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF)
Description
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.
Time Frame
3 months
Title
Five Facet Mindfulness Questionnaire Short Form (FFMQ-SF)
Description
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.
Time Frame
6 months
Title
Self compassion scale Short form (SCS-SF)
Description
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.
Time Frame
Baseline
Title
Self compassion scale Short form (SCS-SF)
Description
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.
Time Frame
3 months
Title
Self compassion scale Short form (SCS-SF)
Description
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.
Time Frame
6 months
10. Eligibility
Sex
All
Gender Based
Yes
Gender Eligibility Description
Male, female, Other
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Physicians enrolled in the database of the medical college of Chile
Exclusion Criteria:
Recent Grief
Severe acute depression disorder
Active suicidal ideation
Active Psychosis
Active addiction
Post Traumatic Stres Disorder
Facility Information:
Facility Name
University Diego Portales
City
Santiago
Country
Chile
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Mindfulness and Intercare Based Intervention for Physicians Burnout Reduction
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