Efficacy of a Mindfulness Program to Reduce Stress and Burnout in Professionals of Medicine and Nursing (MINDUUDD) (MINDUUDD)

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)

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.

Study Overview

• Status: Completed
• Conditions: Stress; Burnout Syndrome
• Intervention / Treatment: Behavioral: Mindfulness and Mindful Self-Compassion

• Study Type: Interventional
• Enrollment (Actual): 132
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Córdoba, Spain, 14011
    • Family Medicine Teaching Unit and Community

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group 4s (mindfulness); Abbreviated program of 4 weeks: will consist of 4 weekly sessions of 2 hours. Participants must practice at home for 15 minutes a day	Behavioral: Mindfulness and Mindful Self-Compassion; Mindfulness Based Stress Reduction (MBSR) and Mindful Self-Compassion
Experimental: Intervention group 8s (mindfulness); Program of 8 weeks: The format will be 8 weekly sessions of 2 hours. Participants must practice at home for 30 minutes a day	Behavioral: Mindfulness and Mindful Self-Compassion; Mindfulness Based Stress Reduction (MBSR) and Mindful Self-Compassion
No Intervention: Control group; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)
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.	Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)
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 .	Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)
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.	Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety and Depression	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.	Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)
Self-perceived health status	Ordinal cualitativ scale: Very bad, bad, good or excellent	Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)

Collaborators and Investigators

• Sponsor: Luis A Perula
• Collaborators: Sociedad Andaluza de Medicina Familiar y Comunitaria

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2019
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: August 2, 2018
• First Submitted That Met QC Criteria: August 11, 2018
• First Posted (Actual): August 14, 2018

Study Record Updates

• Last Update Posted (Actual): March 23, 2021
• Last Update Submitted That Met QC Criteria: March 18, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Burnout, Psychological
• Other Study ID Numbers: MINDUUDD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No