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Burnout, ProfessionalMind-CareNCT02897284

Mindfulness for Burnout Prevention in Primary Care Providers

A study testing Mindfulness 8 weeks and Mindfulness 2 weeks in people with Burnout, Professional, run by Centro Mente Aberta de Mindfulness.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Burnout Syndrome is one of the major challenges for health systems worldwide. This study strives to evaluate the feasibility and effectiveness of an 8- versus 2-week mindfulness-based self-care program on burnout symptoms and psychological and biological variables. Read more about this study

Who is it for?
Ages 18 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Burnout, Professional
What is being tested?
Mindfulness 8 weeks and Mindfulness 2 weeks
Could I receive a placebo?
No, everyone receives an active treatment
How many people
400 participants
Where
No sites listed yet
Study dates
May 2015to Dec 2015
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 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Active Primary Care Providers

Who cannot join

  • Acute disease (physical or mental)
  • Schizophrenia or other psychotic symptoms
  • Concomitant use of medication causing attentional, cognitive or concentration impairments
  • Having practiced mindfulness or other contemplative techniques in the previous 12 months of the study.

About this study

Official title: Evaluation of Mindfulness-based Self-care Programs for the Prevention of Burnout Among Primary Care Providers: Psychological, Inflammatory and Epigenetic Effects

Burnout Syndrome is one of the major challenges for health systems worldwide. This study strives to evaluate the feasibility and effectiveness of an 8- versus 2-week mindfulness-based self-care program on burnout symptoms and psychological and biological variables.

Read the detailed description

The development of stepped-care interventions allows for the development of new strategies within mindfulness-based approaches, classically described as a weekly two-hour commitment which lasts eight weeks. Such approaches might reach larger and stratified groups, more suitable for usage in Brazilian health-system context. For such evaluations, the investigators will use a 3-arms randomized clinical trial design, with Sociodemographic and Labor variables, such as age, sex, number of offspring, adherence to the program, adherence to the mindfulness practices, Burnout Clinical Subtype Questionnaire -(BCSQ-36), Maslach Burnout Inventory (MBI-GS), Mindfulness Attention Awareness Scale (MAAS), Freiburg Mindfulness Inventory adapted for Brazil (FMI-Br-13), Five-Facet Mindfulness Questionnaire (FFMQ-Br). DNA methylation will be measured by Methylase-reaction, and BDNF (brain-derived neurotrophic factor) will be quantified by ELISA-sandwich. The primary outcome will be the effectiveness of such programs on different clinical subtypes of Burnout symptoms (frenetic, under challenged and worn-out). The secondary outcome will be mindfulness levels, and adherence to the program and to the mindfulness practice, and on inflammation and epigenetic variables.

Being tested
Mindfulness 8 weeks, Mindfulness 2 weeks
Keywords
Mindfulness-based, Self-care, Health workers, Epigenetics
Medical subject headings
Burnout, Professional

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness 8 weeksBehavioural

    8 sessions of mindfulness

  • Mindfulness 2 weeksBehavioural

    2 sessions of mindfulness

Study groups in NCT02897284
Study groupRoleWhat they receive
Mindfulness 8 weeksExperimentalMindfulness-based intervention with 8 weekly sessions
Receives: Behavioral: Mindfulness 8 weeks
Mindfulness 2 weeksActive comparatorMindfulness-based intervention with 2 weekly sessions
Receives: Behavioral: Mindfulness 2 weeks
ControlNo interventionwaiting list

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. A mindfulness intervention decreases Burnout

    Evaluation of Burnout symptoms through the MBI-GS scale

    Measured: up to 2 months of follow-up

  2. A mindfulness intervention increases Happiness

    Evaluation of Happiness levels through the PHI (Pemberton) scale

    Measured: up to 2 months of follow-up

Secondary outcomes (5)

  1. A mindfulness intervention increases Mindfulness

    Evaluation of Mindfulness levels through the MAAS scale

    Measured: up to 2 months of follow-up

  2. A mindfulness intervention improves Epigenetic

    Evaluation of epigenetic-related activity through Homocysteine levels (Pfeiffer, 1999)

    Measured: up to 2 months of follow-up

  3. A mindfulness intervention improves Epigenetic (II)

    Evaluation of epigenetic-related activity through Cysteine levels (Pfeiffer, 1999)

    Measured: up to 2 months of follow-up

  4. A mindfulness intervention improves Epigenetic (III)

    Evaluation of epigenetic-related activity through Methylase Reaction (Radiomarking of methyl groups)

    Measured: up to 2 months of follow-up

  5. A mindfulness intervention improves Inflammation

    Evaluation of inflammation-related activity through seric Brain-Derived Neurotrophic Factor - BDNF- (ELISA-Sandwich)

    Measured: up to 2 months of follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Sep 2016 (estimated)
  2. Study startMay 2015
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

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
Single blind
Who is masked
Outcomes assessor
Enrolment
400 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02897284
Sponsor's protocol ID
CMAMindfulness
Acronym
Mind-Care
Status last verified
Sep 2016
First submitted
10 Aug 2016
Last updated
13 Sep 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Barros VV. Evidências de validade da Escala de Atenção e Consciência Plenas (MAAS) e do Questionário das Facetas de Mindfulness (FFMQ-BR) entre usuários de tabaco e população geral [dissertação]. Juiz de Fora (MG): Universidade Federal de Juiz de Fora; 2013.

  • Bower P, Gilbody S. Stepped care in psychological therapies: access, effectiveness and efficiency. Narrative literature review. Br J Psychiatry. 2005 Jan;186:11-7. doi: 10.1192/bjp.186.1.11.

    PubMed 15630118

  • Garcia Campayo J. [The practice of "being attentive" (mindfulness) in medicine. Impact on patients and professionals]. Aten Primaria. 2008 Jul;40(7):363-6. doi: 10.1157/13124130. No abstract available. Spanish.

    PubMed 18620639

  • Cavanagh K, Strauss C, Cicconi F, Griffiths N, Wyper A, Jones F. A randomised controlled trial of a brief online mindfulness-based intervention. Behav Res Ther. 2013 Sep;51(9):573-8. doi: 10.1016/j.brat.2013.06.003. Epub 2013 Jun 28.

    PubMed 23872699

  • Coyle D, Doherty G. Stepped care and mental health technologies, en ECCE 2010 workshop on Cognitive Engineering for Technology in Mental Health Care and Rehabilitation, pp. 99-102, 2010.

  • Demarzo MMP. Meditação aplicada à saúde. Programa Atualização em Med Família e Comunidade. 6th ed. Porto ALegre-RS: Artmed; 2011;6(1):1-18.

  • Demarzo MM, Andreoni S, Sanches N, Perez S, Fortes S, Garcia-Campayo J. Mindfulness-based stress reduction (MBSR) in perceived stress and quality of life: an open, uncontrolled study in a Brazilian healthy sample. Explore (NY). 2014 Mar-Apr;10(2):118-20. doi: 10.1016/j.explore.2013.12.005. Epub 2013 Dec 18. No abstract available.

    PubMed 24607079

  • Epstein RM, Krasner MS. Physician resilience: what it means, why it matters, and how to promote it. Acad Med. 2013 Mar;88(3):301-3. doi: 10.1097/ACM.0b013e318280cff0.

    PubMed 23442430

  • Gluck TM, Maercker A. A randomized controlled pilot study of a brief web-based mindfulness training. BMC Psychiatry. 2011 Nov 8;11:175. doi: 10.1186/1471-244X-11-175.

    PubMed 22067058

  • Hesser H, Gustafsson T, Lunden C, Henrikson O, Fattahi K, Johnsson E, Zetterqvist Westin V, Carlbring P, Maki-Torkko E, Kaldo V, Andersson G. A randomized controlled trial of Internet-delivered cognitive behavior therapy and acceptance and commitment therapy in the treatment of tinnitus. J Consult Clin Psychol. 2012 Aug;80(4):649-61. doi: 10.1037/a0027021. Epub 2012 Jan 16.

    PubMed 22250855

  • Hirayama MS. Freiburg Mindfulness Inventory: Adaptação cultural e validação para a língua portuguesa no Brasil. [tese]. Campinas (SP): Universidade estadual de Campinas, 2014.

  • Hirayama MS, Milani D, Rodrigues RC, Barros NF, Alexandre NM. [The perception of behavior related to mindfulness and the Brazilian version of the Freiburg Mindfulness Inventory]. Cien Saude Colet. 2014 Sep;19(9):3899-914. doi: 10.1590/1413-81232014199.12272013. Portuguese.

    PubMed 25184595

  • Irving JA, Dobkin PL, Park J. Cultivating mindfulness in health care professionals: a review of empirical studies of mindfulness-based stress reduction (MBSR). Complement Ther Clin Pract. 2009 May;15(2):61-6. doi: 10.1016/j.ctcp.2009.01.002. Epub 2009 Feb 28.

    PubMed 19341981

  • Franco Justo C. [Reducing stress levels and anxiety in primary-care physicians through training and practice of a mindfulness meditation technique]. Aten Primaria. 2010 Nov;42(11):564-70. doi: 10.1016/j.aprim.2009.10.020. Epub 2010 Feb 2. Spanish.

    PubMed 20129713

  • Keng SL, Smoski MJ, Robins CJ. Effects of mindfulness on psychological health: a review of empirical studies. Clin Psychol Rev. 2011 Aug;31(6):1041-56. doi: 10.1016/j.cpr.2011.04.006. Epub 2011 May 13.

    PubMed 21802619

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness 8 weeks and Mindfulness 2 weeks in people with Burnout, Professional, run by Centro Mente Aberta de Mindfulness.

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 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.

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?

A mindfulness intervention decreases Burnout (time frame: up to 2 months of follow-up). The study lists 2 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 NCT02897284, which also lists 39 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 13 Sep 2016.

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