Burnout SyndromeMINDFULNESSNCT02387528
Efficacy of a Mindfulness-Based Intervention Versus Relaxation in Primary Care Burnout Providers.
A study testing 1- Mindfulness Intervention and 2- Relaxation Intervention in people with Burnout Syndrome, run by Federal University of São Paulo at 1 site in Brazil.
Trial summary
The prevalence of the Burnout Syndrome (BS) or symptoms among Primary Health Care (PHC) providers is high and can affect their quality of life and clinical results. Mindfulness-based interventions (MBI) have been tested as promising interventions to manage chronic stress and BS in PHC providers. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Burnout Syndrome
- What is being tested?
- 1- Mindfulness Intervention and 2- Relaxation Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2014to 9 Oct 2018
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Volunteers over 18 years old who consent to be randomized to one of two groups, and
- have available time to join the research
Who cannot join
- Practitioners of mindfulness, meditation yoga or similar in last year,
- presence of not controlled greater severity diseases, such as cancer, schizophrenia, epilepsy, or other psychiatric diseases,
- alcohol or other drugs addiction or abuse, except tobacco, and
- being in acute treatment for psychological or psychiatric problems. All volunteers will undergo a brief initial clinical evaluation to assess whether the conditions of mental and physical health permit participation in groups.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of a Mindfulness-Based Intervention ("Breathworks for Stress") Versus Relaxation in the Symptoms of Burnout in Primary Care Providers: A Mixed-Methods Pragmatic Controlled Study
The prevalence of the Burnout Syndrome (BS) or symptoms among Primary Health Care (PHC) providers is high and can affect their quality of life and clinical results. Mindfulness-based interventions (MBI) have been tested as promising interventions to manage chronic stress and BS in PHC providers.
The main goal of this study was to compare the efficacy of an eight week MBI (Group 1 or G1) on burnout symptoms in Brazilian PHC providers, compared to a briefer, four-week relaxation-based intervention (Group 2 or G2) and to a waiting list control group (Group 3 or G3). The initial hypothesis was that the MBI is superior to relaxation and to the waiting list group. A non-randomized controlled trial was performed, with mixed-methods evaluation (qualitative and quantitative).
Read the detailed description
Study Design: a non-randomized pragmatic controlled trial was performed, with mixed-methods investigation.
Population: The target population of the study were PHC professionals from the city of Porto Alegre in the southern region of Brazil.
Sample: PHC professionals from 50 health units. A sample size calculation was performed, considering an effect size of 0.5 (moderate), with a statistical power of 80% and a confidence interval of 95%. Thus, 65 individuals in each group would be necessary, totaling 195 people distributed in the three groups, estimating a drop-out rate of 10%.
Inclusion criteria: 18 years or over, complete primary education at least, be interested in the objectives of this study and have consented to volunteer to participate in one of the three groups of interventions proposed, being a primary health care worker for at least six months and experiencing any kind of stress in relation to work.
Exclusion criteria: Have been practicing mindfulness, meditation, yoga or similar (tai chi chuan, qi gong) in the last six months, presence of diagnosed clinical diseases that would not allow adherence to the study, being in treatment for psychological or psychiatric problems, in the phase of therapeutic adjustment (less than three months of psychological or pharmacological interventions), be on medical leave of absence from work, dependence or abusive use of alcohol or other drugs, except for tobacco.
Recruitment and procedures: The study was publicized among all PHC units using informative pamphlets, and PHC managers were informed personally by the first author (DS) about the goals of the project. The professionals were dismissed during working hours for the meetings that took place in places available and previously scheduled with the heads of health services. All the volunteers were previously submitted to the study´s criteria for participation. Those who were interested underwent a brief evaluation using the Beck´s Depression Inventory (BDI), Self Reported Questionnaire (SRQ-20) (common mental disorders) and Self Reported Questionnaire (SRQ-A) (alcohol use) scales to exclude severe symptoms (suicidal ideation and alcohol abuse). After inclusion, volunteers were able to choose between the three participant groups of the study (mindfulness, relaxation, or waiting list). We did not randomize the professionals in order to make the study more feasible and pragmatic. Specifically, in a pilot study we had observed that the professionals were highly resistant to being randomly allocated to the study groups.
Ethics: This study was conducted according to the Declaration of Helsinki and was submitted to three Research Ethics Committees, respecting all the criteria for the execution of research with human beings.
All participants agreed to participate in the study and signed the Free and Informed Consent prior to any study procedure.
A drop-out was defined as a participant who completed fewer than four sessions.
Measures:
Added to sociodemographic data, the Maslach Burnout Inventory - General Survey) (MBI-GS ) was used to identify symptoms of BS, The Positive and Negative Scale (PANAS) to evaluate affection, Five Facet Mindfulness Questionnaire (FFMQ) to measure mindfulness dimensions; the Experience Scale to measure decentering and rumination (ES), and the Self-Compassion Scale (SCS) to measure compassion.
- Conditions
- Burnout Syndrome
- Being tested
- 1- Mindfulness Intervention, 2- Relaxation Intervention, 3- Wait List Control Group
- Keywords
- MIndfulness, Primary Health Care
- Medical subject headings
- Burnout, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1- Mindfulness InterventionBehavioural
Also called Mindfulness Based Stress Reduction
An intervention program integrating elements of Mindfulness Breathworks Institute Mindfulness based approaches for Pain and illness (MBPI), (Burch , 2009) and Mindfulness Based Stress Reduction (MBSR), (Kabat Zinn, 2003), and Mindfulness based Cognitive Therapy (MBCT) shall be used. All programs are highly structured, lasting eight weeks, with a weekly meeting about two hours , and working with four main techniques during these meetings : mindfulness in breathing, body scan, walking meditation and mindfulness yoga. In order to facilitate the home practice of meditation by participants during and after the intervention protocol, all will receive a CD containing guided meditation sessions, covering the above techniques.
2- Relaxation InterventionBehavioural
Also called Relaxation
Eight meetings where the participants will practice relaxation techniques.
3- Wait List Control GroupOther
Also called Wait List
No intervention
| Study group | Role | What they receive |
|---|---|---|
| 1- Mindfulness Intervention | Experimental | Mindfulness-Based Intervention: The intervention model tested was "Breathworks for Stress".The mindfulness intervention used in the study had a total of eight encounters, lasting 120 minutes, that took place once a week. In order to accommodate employees' schedule. There was a recommendation of daily practice lasting an average of 15 minutes, as well as the suggestion to use the tools in everyday life.
In each session a theme was presented, with distinct practices and well-defined objectives Receives: Behavioral: 1- Mindfulness Intervention |
| 2- Relaxation Intervention | Placebo comparator | Relaxation-Based Intervention was composed of four meetings, of two hours duration, held every two weeks. The activities involved mutual help conversations about work situations, psychoeducation on stress and various techniques of stress inoculation, such as: diaphragmatic breathing, progressive muscle relaxation, relaxing visualization and stretching. Each session had its own objective to promote the relaxation response effect. Receives: Behavioral: 2- Relaxation Intervention |
| 3- Wait List Control Group | Other | The wait list passive control group did not receive any intervention while the study was been enrolling. Receives: Other: 3- Wait List Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
A mindfulness intervention decreases burnout symptoms
Measured by MBI-GS.
Measured: up to 2 months
Secondary outcomes (4)
A mindfulness intervention decreases negative affect and increases positive affect
After the intervention, measured by PANAS
Measured: up to 2 months
A mindfulness intervention improves self compassion
measured by SCE after intervention.
Measured: up to 2 months
A mindfulness intervention Increases mindfulness state.
measured by FFMQ
Measured: up to 2 months
A mindfulness intervention improves decentering and decrease cognitive rumination
Measured by ES - Experience scale
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2015 (estimated)
- Study startSep 2014
- Primary completionSep 2014
- Study completion9 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burnout SyndromeStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of São Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Responsible party
- Principal investigator, Daniela D. Sopezki, Federal University of São Paulo
- Investigators
- Daniela Sopezki, MD, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02387528
- Sponsor's protocol ID
- CEP639061
- Acronym
- MINDFULNESS
- Status last verified
- Mar 2019
- First submitted
- 6 Mar 2015
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Mindfulness-Based Intervention ("Breathworks for Stress") Versus Relaxation in the Symptoms of Burnout in Primary Care Providers: A Mixed-Methods Pragmatic Controlled Study
- ClinicalTrials.gov ID
- NCT02387528
- Acronym / sponsor ID
- MINDFULNESS / CEP639061
- Conditions
- Burnout Syndrome
- Keywords
- MIndfulness, Primary Health Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Federal University of São PauloUniversity, hospital or other
- Collaborators
- Federal University of Rio Grande do Sul
- Study start
- Sep 2014
- Primary completion
- Sep 2014 (actual)
- Study completion
- 9 Oct 2018 (actual)
- First posted
- 13 Mar 2015 (estimated)
- 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 prevalence of the Burnout Syndrome (BS) or symptoms among Primary Health Care (PHC) providers is high and can affect their quality of life and clinical results. Mindfulness-based interventions (MBI) have been tested as promising interventions to manage chronic stress and BS in PHC providers.
The main goal of this study was to compare the efficacy of an eight week MBI (Group 1 or G1) on burnout symptoms in Brazilian PHC providers, compared to a briefer, four-week relaxation-based intervention (Group 2 or G2) and to a waiting list control group (Group 3 or G3). The initial hypothesis was that the MBI is superior to relaxation and to the waiting list group. A non-randomized controlled trial was performed, with mixed-methods evaluation (qualitative and quantitative).
Detailed description
Study Design: a non-randomized pragmatic controlled trial was performed, with mixed-methods investigation.
Population: The target population of the study were PHC professionals from the city of Porto Alegre in the southern region of Brazil.
Sample: PHC professionals from 50 health units. A sample size calculation was performed, considering an effect size of 0.5 (moderate), with a statistical power of 80% and a confidence interval of 95%. Thus, 65 individuals in each group would be necessary, totaling 195 people distributed in the three groups, estimating a drop-out rate of 10%.
Inclusion criteria: 18 years or over, complete primary education at least, be interested in the objectives of this study and have consented to volunteer to participate in one of the three groups of interventions proposed, being a primary health care worker for at least six months and experiencing any kind of stress in relation to work.
Exclusion criteria: Have been practicing mindfulness, meditation, yoga or similar (tai chi chuan, qi gong) in the last six months, presence of diagnosed clinical diseases that would not allow adherence to the study, being in treatment for psychological or psychiatric problems, in the phase of therapeutic adjustment (less than three months of psychological or pharmacological interventions), be on medical leave of absence from work, dependence or abusive use of alcohol or other drugs, except for tobacco.
Recruitment and procedures: The study was publicized among all PHC units using informative pamphlets, and PHC managers were informed personally by the first author (DS) about the goals of the project. The professionals were dismissed during working hours for the meetings that took place in places available and previously scheduled with the heads of health services. All the volunteers were previously submitted to the study´s criteria for participation. Those who were interested underwent a brief evaluation using the Beck´s Depression Inventory (BDI), Self Reported Questionnaire (SRQ-20) (common mental disorders) and Self Reported Questionnaire (SRQ-A) (alcohol use) scales to exclude severe symptoms (suicidal ideation and alcohol abuse). After inclusion, volunteers were able to choose between the three participant groups of the study (mindfulness, relaxation, or waiting list). We did not randomize the professionals in order to make the study more feasible and pragmatic. Specifically, in a pilot study we had observed that the professionals were highly resistant to being randomly allocated to the study groups.
Ethics: This study was conducted according to the Declaration of Helsinki and was submitted to three Research Ethics Committees, respecting all the criteria for the execution of research with human beings.
All participants agreed to participate in the study and signed the Free and Informed Consent prior to any study procedure.
A drop-out was defined as a participant who completed fewer than four sessions.
Measures:
Added to sociodemographic data, the Maslach Burnout Inventory - General Survey) (MBI-GS ) was used to identify symptoms of BS, The Positive and Negative Scale (PANAS) to evaluate affection, Five Facet Mindfulness Questionnaire (FFMQ) to measure mindfulness dimensions; the Experience Scale to measure decentering and rumination (ES), and the Self-Compassion Scale (SCS) to measure compassion.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1- Mindfulness Intervention | Experimental | Behavioral: 1- Mindfulness InterventionMindfulness-Based Intervention: The intervention model tested was "Breathworks for Stress".The mindfulness intervention used in the study had a total of eight encounters, lasting 120 minutes, that took place once a week. In order to accommodate employees' schedule. There was a recommendation of daily practice lasting an average of 15 minutes, as well as the suggestion to use the tools in everyday life. In each session a theme was presented, with distinct practices and well-defined objectives |
| 2- Relaxation Intervention | Placebo comparator | Behavioral: 2- Relaxation InterventionRelaxation-Based Intervention was composed of four meetings, of two hours duration, held every two weeks. The activities involved mutual help conversations about work situations, psychoeducation on stress and various techniques of stress inoculation, such as: diaphragmatic breathing, progressive muscle relaxation, relaxing visualization and stretching. Each session had its own objective to promote the relaxation response effect. |
| 3- Wait List Control Group | Other | Other: 3- Wait List Control GroupThe wait list passive control group did not receive any intervention while the study was been enrolling. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Volunteers over 18 years old who consent to be randomized to one of two groups, and
- have available time to join the research
Key exclusion criteria (4 listed)
- Practitioners of mindfulness, meditation yoga or similar in last year,
- presence of not controlled greater severity diseases, such as cancer, schizophrenia, epilepsy, or other psychiatric diseases,
- alcohol or other drugs addiction or abuse, except tobacco, and
- being in acute treatment for psychological or psychiatric problems. All volunteers will undergo a brief initial clinical evaluation to assess whether the conditions of mental and physical health permit participation in groups.
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 |
|---|---|---|
| 1- Mindfulness InterventionAlso: Mindfulness Based Stress ReductionAn intervention program integrating elements of Mindfulness Breathworks Institute Mindfulness based approaches for Pain and illness (MBPI), (Burch , 2009) and Mindfulness Based Stress Reduction (MBSR), (Kabat Zinn, 2003), and Mindfulness based Cognitive Therapy (MBCT) shall be used. All programs are highly structured, lasting eight weeks, with a weekly meeting about two hours , and working with four main techniques during these meetings : mindfulness in breathing, body scan, walking meditation and mindfulness yoga. In order to facilitate the home practice of meditation by participants during and after the intervention protocol, all will receive a CD containing guided meditation sessions, covering the above techniques. | Behavioural | 1- Mindfulness Intervention |
| 2- Relaxation InterventionAlso: RelaxationEight meetings where the participants will practice relaxation techniques. | Behavioural | 2- Relaxation Intervention |
| 3- Wait List Control GroupAlso: Wait ListNo intervention | Other | 3- Wait List Control Group |
Primary outcome
A mindfulness intervention decreases burnout symptoms
Time frame: up to 2 months
Measured by MBI-GS.
4 secondary outcomes
A mindfulness intervention decreases negative affect and increases positive affect
Time frame: up to 2 months
A mindfulness intervention improves self compassion
Time frame: up to 2 months
A mindfulness intervention Increases mindfulness state.
Time frame: up to 2 months
A mindfulness intervention improves decentering and decrease cognitive rumination
Time frame: up to 2 months
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 29 Mar 2019.
- Individual participant dataSharing planned: No
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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.
Daniela Sopezki, MD principal investigator
Federal University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 1- Mindfulness Intervention and 2- Relaxation Intervention in people with Burnout Syndrome, run by Federal University of São Paulo at 1 site in Brazil.
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 2 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 29 Mar 2019. 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 Brazil. 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. Some participants in this study may receive a placebo. 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?
A mindfulness intervention decreases burnout symptoms (time frame: up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Mar 2019.