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

Stress Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03629457
• Other study ID #: MINDUUDD
• Status: Completed
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: February 1, 2021

Study information

• Verified date: March 2021
• Source: Hospital Universitario Reina Sofia de Cordoba
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: February 1, 2021
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Burnout Syndrome
• Burnout, Psychological
• Stress

Intervention

Behavioral:
• Mindfulness and Mindful Self-Compassion
Mindfulness Based Stress Reduction (MBSR) and Mindful Self-Compassion

Locations

Country	Name	City	State
Spain	Family Medicine Teaching Unit and Community	Córdoba

Sponsors (2)

Lead Sponsor	Collaborator
Luis A Perula	Sociedad Andaluza de Medicina Familiar y Comunitaria

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)