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Completed

NCT Number: NCT03629457

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

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.

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Key information

Conditions

Stress Behavior Behavioral Symptoms Burnout Syndrome Burnout, Psychological Stress, Psychological

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Family Medicine Teaching Unit and Community

Córdoba, 14011, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness and Mindful Self-Compassion

Behavioral

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

Primary outcomes

  1. Degree of occupational stress

    Time frame: Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)

    An ordinal scale that ranges from 0 (no degree of stress) to 10 (maximum degree of stress) stress, will be used

  2. Degree of occupational stress

    Time frame: Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)

    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.

  3. Degree of burnout

    Time frame: Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)

    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 .

  4. Degree of Self-Compassion

    Time frame: Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)

    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 outcomes

  1. Degree of empathy

    Time frame: Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)

    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.

Other outcomes

  1. Anxiety and Depression

    Time frame: Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)

    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.

  2. Self-perceived health status

    Time frame: Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)

    Ordinal cualitativ scale: Very bad, bad, good or excellent

Sponsors and collaborators

Lead sponsor

Luis A Perula

Other Gov

Collaborators

  • Sociedad Andaluza de Medicina Familiar y Comunitaria

Registry information

Official study 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)

Acronym: MINDUUDD

Important dates

Study start
2019
Primary completion
2020
Study completion
2021
First posted
Aug 14, 2018
Registry last updated
Mar 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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