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

NCT03629457 | Completed DMC

• 1 other identifier: MINDUUDD
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Burnout Syndrome

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Degree of empathy

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

Other Outcomes (2)

• Anxiety and Depression

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

• Self-perceived health status

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

Study Arms (3)

Intervention group 4s (mindfulness)

EXPERIMENTAL

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

Intervention group 8s (mindfulness)

EXPERIMENTAL

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

Control group

NO INTERVENTION

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)

Interventions

Mindfulness and Mindful Self-Compassion BEHAVIORAL

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

Intervention group 4s (mindfulness); Intervention group 8s (mindfulness)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Health professionals (doctors and nurses tutors and residents) assigned to 6 teaching units of family and community care, which are active.

You may not qualify if:

• 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

Sponsors & Collaborators

• Luis A Perula: lead
• Sociedad Andaluza de Medicina Familiar y Comunitaria: collaborator

Study Sites (1)

Family Medicine Teaching Unit and Community

Córdoba, 14011, Spain

Location

Related Publications (2)

• 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.

  PMID: 33530929 DERIVED

• 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.

  PMID: 30727962 DERIVED

MeSH Terms

Conditions

Burnout, Psychological

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor in medicine. Specialist in Preventive Medicine and Public Health. Health Technician Teaching Unit Family and Community Medicine

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: August 14, 2018
• Study Start: June 1, 2019
• Primary Completion: June 1, 2020
• Study Completion: February 1, 2021
• Last Updated: March 23, 2021

Record last verified: 2021-03

Locations

ES (1)