StressMINDUUDDNCT03629457
Efficacy of a Mindfulness Program to Reduce Stress and Burnout in Professionals of Medicine and Nursing (MINDUUDD)
A study testing Mindfulness and Mindful Self-Compassion in people with Stress and Burnout Syndrome, run by Luis A Perula at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stress, Burnout Syndrome
- What is being tested?
- Mindfulness and Mindful Self-Compassion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2019to 1 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Health professionals (doctors and nurses tutors and residents) assigned to 6 teaching units of family and community care, which are active.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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).
Read more
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
- Being tested
- Mindfulness and Mindful Self-Compassion
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness and Mindful Self-CompassionBehavioural
Mindfulness Based Stress Reduction (MBSR) and Mindful Self-Compassion
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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 .
Measured: 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.
Measured: Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)
Secondary outcomes (1)
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.
Measured: Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start1 Jun 2019
- Primary completion1 Jun 2020
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- Luis A Perula
- Sponsor type
- Other government
- Collaborators
- Sociedad Andaluza de Medicina Familiar y Comunitaria
- Responsible party
- Sponsor-investigator, Luis A Perula, Hospital Universitario Reina Sofia de Cordoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03629457
- Sponsor's protocol ID
- MINDUUDD
- Acronym
- MINDUUDD
- Status last verified
- Mar 2021
- First submitted
- 2 Aug 2018
- Last updated
- 23 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 33530929Perula-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.
PubMed 30727962
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03629457
- Acronym / sponsor ID
- MINDUUDD / MINDUUDD
- Conditions
- Stress, Burnout Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- Luis A PerulaOther government
- Collaborators
- Sociedad Andaluza de Medicina Familiar y Comunitaria
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention group 4s (mindfulness) | Experimental | Behavioral: Mindfulness and Mindful Self-CompassionAbbreviated program of 4 weeks: will consist of 4 weekly sessions of 2 hours. Participants must practice at home for 15 minutes a day |
| Intervention group 8s (mindfulness) | Experimental | Behavioral: Mindfulness and Mindful Self-CompassionProgram of 8 weeks: The format will be 8 weekly sessions of 2 hours. Participants must practice at home for 30 minutes a day |
| 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) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Health professionals (doctors and nurses tutors and residents) assigned to 6 teaching units of family and community care, which are active.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness and Mindful Self-CompassionMindfulness Based Stress Reduction (MBSR) and Mindful Self-Compassion | Behavioural | Intervention group 4s (mindfulness), Intervention group 8s (mindfulness) |
Primary outcome
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
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.
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 .
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.
1 secondary outcome
Degree of empathy
Time frame: Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
- Derived from this study: PubMed 33530929Magallon-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.
- Derived from this study: PubMed 30727962Perula-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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness and Mindful Self-Compassion in people with Stress and Burnout Syndrome, run by Luis A Perula at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of occupational stress (time frame: Change from baseline at 4 weeks (EG4) or 8 weeks (EG8 or CG)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03629457, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.