Efficacy of a Mindfulness Program to Reduce Stress and Burnout in Professionals of Medicine and Nursing (MINDUUDD) (MINDUUDD)
Primary Purpose
Stress, Burnout Syndrome
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Mindfulness and Mindful Self-Compassion
Sponsored by
About this trial
This is an interventional prevention trial for Stress
Eligibility Criteria
Inclusion Criteria:
- Health professionals (doctors and nurses tutors and residents) assigned to 6 teaching units of family and community care, which are active.
Exclusion Criteria:
- That you have previously done a training course or workshop in mindfulness of at least 4 weeks.
- That during the field work they are in a situation of prolonged or long-term sick leave.
- Have mental disorders that discourage the intervention.
- That they do not give their informed consent to participate
Sites / Locations
- Family Medicine Teaching Unit and Community
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Intervention group 4s (mindfulness)
Intervention group 8s (mindfulness)
Control group
Arm Description
Abbreviated program of 4 weeks: will consist of 4 weekly sessions of 2 hours. Participants must practice at home for 15 minutes a day
Program of 8 weeks: The format will be 8 weekly sessions of 2 hours. Participants must practice at home for 30 minutes a day
The participants will only receive a one-hour information session and will be invited to complete the questionnaires provided in two moments of the time (coinciding with the interventions in the experimental groups)
Outcomes
Primary Outcome Measures
Degree of occupational stress
An ordinal scale that ranges from 0 (no degree of stress) to 10 (maximum degree of stress) stress, will be used
Degree of occupational stress
PSQ questionnaire (Perceived Stress Questionnaire). It consists of 30 items that can be scored using a Likert scale (1 to 4). Higher total values indicate more stress.
Degree of burnout
Maslach Burnout Inventory-General Survey (MBI). Spanish version of the MBI-HSS25. It consists of 22 scoring items from 0 to 6 that measure the three dimensions of the syndrome: emotional fatigue (CE), 9 items and a maximum score of 54 points; depersonalization (DP), 5 items and maximum score of 30 points; personal fulfillment (RP), 8 items and maximum score of 48 points. The cut points used were: emotional fatigue under <19, moderate 19-26, high> 26. Depersonalization under <6, moderate 6-9, high> 9. Personal performance under> 39, moderate 39-34, high <34 .
Degree of Self-Compassion
Self-compassion questionnaire. The short scale of the Spanish version, validated by García-Campayo et al, will be used, with 12 items scored using a Likert scale (1 to 5) that measures how the subject usually acts towards himself in difficult moments. It consists of six subscales: self-friendliness, common humanity, mindfulness, and their opposites: self-judgment, isolation and over-identification. Higher total values indicate more self-pity.
Secondary Outcome Measures
Degree of empathy
Jefferson Medical Empathy Scale (EEMJ), HP version. Defines empathy based on three factors: "perspective taking", "compassionate care" and the ability to "put yourself in the patient's shoes". It has a minimum score of 20, maximum of 140 and does not establish a cut-off point, it contains 20 Likert-type items on a 7-point scale. There are 10 items written in the positive sense and 10 in the negative sense.
Full Information
NCT ID
NCT03629457
First Posted
August 2, 2018
Last Updated
March 18, 2021
Sponsor
Luis A Perula
Collaborators
Sociedad Andaluza de Medicina Familiar y Comunitaria
1. Study Identification
Unique Protocol Identification Number
NCT03629457
Brief Title
Efficacy of a Mindfulness Program to Reduce Stress and Burnout in Professionals of Medicine and Nursing (MINDUUDD)
Acronym
MINDUUDD
Official Title
Efficacy of a Training Program in Mindfulness and Self-Compassion of 4 Sessions in Front of the 8 Sessions to Reduce Work Stress and Burnout in Professionals of Medicine and Nursing (MINDUUDD Project)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
June 1, 2020 (Actual)
Study Completion Date
February 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Luis A Perula
Collaborators
Sociedad Andaluza de Medicina Familiar y Comunitaria
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective is to check whether a training program in mindfulness and self-pity based on a 4-session intervention (abbreviated program) is as effective as the standard 8-session MBSR program in reducing work stress and burnout in tutors and residents of Medicine and Family and Community Nursing.
It is a controlled clinical trial, randomized by cluster, of three parallel arms, multicentric. Six teaching units (ratio 1: 1: 1) will be randomized to one of the three study groups: 1) Experimental Group-8 (EG8); 2) Experimental Group-4 (EG4); 3) Control group (CG).
At least 132 subjects will participate, 44 in the EG8, 44 in the EG4 and 44 in the CG.
The interventions will be based on the MBSR (Mindfulness Based Stress Reduction) program, to which some of the practices of the MSC (Mindful Self-Compassion) program will be added.
The EG8 intervention will be carried out during 8 weekly sessions of 2.5 hours, while the EG4 intervention will be of 4 sessions of 2.5 hours. The participants will have to practice at home for 30 minutes / day in the EG8 and 15 minutes / day in the EG4.
In the 3 groups the questionnaires FFMQ (mindfulness), SCS (self-pity), ordinal scale (0-10) and questionnaire PSQ (perceived stress) and MBI (burnout) will be passed. Empathy will also be measured, through the EEMJ, anxiety and depression disorders (EADG) and self-perceived health status.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Burnout Syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
132 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention group 4s (mindfulness)
Arm Type
Experimental
Arm Description
Abbreviated program of 4 weeks: will consist of 4 weekly sessions of 2 hours. Participants must practice at home for 15 minutes a day
Arm Title
Intervention group 8s (mindfulness)
Arm Type
Experimental
Arm Description
Program of 8 weeks: The format will be 8 weekly sessions of 2 hours. Participants must practice at home for 30 minutes a day
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The participants will only receive a one-hour information session and will be invited to complete the questionnaires provided in two moments of the time (coinciding with the interventions in the experimental groups)
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness and Mindful Self-Compassion
Intervention Description
Mindfulness Based Stress Reduction (MBSR) and Mindful Self-Compassion
Primary Outcome Measure Information:
Title
Degree of occupational stress
Description
An ordinal scale that ranges from 0 (no degree of stress) to 10 (maximum degree of stress) stress, will be used
Time Frame
Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)
Title
Degree of occupational stress
Description
PSQ questionnaire (Perceived Stress Questionnaire). It consists of 30 items that can be scored using a Likert scale (1 to 4). Higher total values indicate more stress.
Time Frame
Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)
Title
Degree of burnout
Description
Maslach Burnout Inventory-General Survey (MBI). Spanish version of the MBI-HSS25. It consists of 22 scoring items from 0 to 6 that measure the three dimensions of the syndrome: emotional fatigue (CE), 9 items and a maximum score of 54 points; depersonalization (DP), 5 items and maximum score of 30 points; personal fulfillment (RP), 8 items and maximum score of 48 points. The cut points used were: emotional fatigue under <19, moderate 19-26, high> 26. Depersonalization under <6, moderate 6-9, high> 9. Personal performance under> 39, moderate 39-34, high <34 .
Time Frame
Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)
Title
Degree of Self-Compassion
Description
Self-compassion questionnaire. The short scale of the Spanish version, validated by García-Campayo et al, will be used, with 12 items scored using a Likert scale (1 to 5) that measures how the subject usually acts towards himself in difficult moments. It consists of six subscales: self-friendliness, common humanity, mindfulness, and their opposites: self-judgment, isolation and over-identification. Higher total values indicate more self-pity.
Time Frame
Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)
Secondary Outcome Measure Information:
Title
Degree of empathy
Description
Jefferson Medical Empathy Scale (EEMJ), HP version. Defines empathy based on three factors: "perspective taking", "compassionate care" and the ability to "put yourself in the patient's shoes". It has a minimum score of 20, maximum of 140 and does not establish a cut-off point, it contains 20 Likert-type items on a 7-point scale. There are 10 items written in the positive sense and 10 in the negative sense.
Time Frame
Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)
Other Pre-specified Outcome Measures:
Title
Anxiety and Depression
Description
Goldberg Anxiety and Depression Scale (GADS, EADG in spanish versión). It consists of two sub-scales, one of anxiety and the other of depression. Each sub-scale has 9 items of dichotomous response (Yes / No) and are structured in 4 initial items of screening, to determine whether or not there is likely to be a mental disorder, and a second group of 5 items that are formulated if you get positive answers to the screening questions (2 or more for anxiety and more than 1 for depression), but in the investigation the full scale is usually applied, and that way it was used in the present study. an independent score for each scale, with a point for each affirmative answer. Goldberg et al have proposed cutoff points ≥ 4 for the anxiety scale, and ≥ 2 for depression.
Time Frame
Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)
Title
Self-perceived health status
Description
Ordinal cualitativ scale: Very bad, bad, good or excellent
Time Frame
Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Health professionals (doctors and nurses tutors and residents) assigned to 6 teaching units of family and community care, which are active.
Exclusion Criteria:
That you have previously done a training course or workshop in mindfulness of at least 4 weeks.
That during the field work they are in a situation of prolonged or long-term sick leave.
Have mental disorders that discourage the intervention.
That they do not give their informed consent to participate
Facility Information:
Facility Name
Family Medicine Teaching Unit and Community
City
Córdoba
ZIP/Postal Code
14011
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33530929
Citation
Magallon-Botaya R, Perula-de Torres LA, Verdes-Montenegro Atalaya JC, Perula-Jimenez C, Lietor-Villajos N, Bartolome-Moreno C, Garcia-Campayo J, Moreno-Martos H; Minduudd Collaborative Study Group. Mindfulness in primary care healthcare and teaching professionals and its relationship with stress at work: a multicentric cross-sectional study. BMC Fam Pract. 2021 Feb 2;22(1):29. doi: 10.1186/s12875-021-01375-2.
Results Reference
derived
PubMed Identifier
30727962
Citation
Perula-de Torres LA, Atalaya JCV, Garcia-Campayo J, Roldan-Villalobos A, Magallon-Botaya R, Bartolome-Moreno C, Moreno-Martos H, Melus-Palazon E, Lietor-Villajos N, Valverde-Bolivar FJ, Hachem-Salas N, Rodriguez LA, Navarro-Gil M, Epstein R, Cabezon-Crespo A, Moreno CM; collaborative group of the MINDUUDD study. Controlled clinical trial comparing the effectiveness of a mindfulness and self-compassion 4-session programme versus an 8-session programme to reduce work stress and burnout in family and community medicine physicians and nurses: MINDUUDD study protocol. BMC Fam Pract. 2019 Feb 6;20(1):24. doi: 10.1186/s12875-019-0913-z.
Results Reference
derived
Learn more about this trial
Efficacy of a Mindfulness Program to Reduce Stress and Burnout in Professionals of Medicine and Nursing (MINDUUDD)
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