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Burnout, ProfessionalNCT04336436

The Impact of Combined Mindfulness-Based Interventions and Nutritional Counseling on Physician Burnout

A study testing Mindfulness training and Nutritional consult in people with Burnout, Professional, run by The Cleveland Clinic at 1 site in United States.

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

This study is designed to tackle the issue of physician burnout via a wide-lens approach, integrating both mindfulness-based training and nutritional counseling in the management of professional burnout. Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
Conditions the study is for
Burnout, Professional
What is being tested?
Mindfulness training and Nutritional consult
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
20 Dec 2019to 31 Dec 2020
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

  • Physician employed by Cleveland Clinic
  • Located in Ohio
  • Must anticipate remaining employed for at least 6 months post-enrollment

Who cannot join

  • Non-MD or non-DO healthcare providers
  • Unable to commit to intervention sessions
  • Current diagnosis of uncontrolled hypertension, and/or uncontrolled diabetes mellitus (defined as hemoglobin A1c ≥9%)
  • Current or previous history of Cushing's disease or pheochromocytoma/paraganglioma

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Cleveland Clinic

    Cleveland, Ohio, 44195

Other trials in United States

About this study

Official title: The Impact of Combined Mindfulness-Based Interventions and Nutritional Counseling on Physician Burnout: A Clinical Trial

This study is designed to tackle the issue of physician burnout via a wide-lens approach, integrating both mindfulness-based training and nutritional counseling in the management of professional burnout. The investigators will evaluate the effects of mindfulness training and nutritional counseling interventions through assessment of changes in physiological and biochemical parameters known to be adversely affected in burnout, in addition to the standardized Professional Fulfillment inventory scores at 3-6 months post-intervention.

Read the detailed description

There is a preponderance of data to support the detrimental effects of burnout on physicians' health and wellbeing. Physician burnout is defined as severe emotional exhaustion, depersonalization towards others and reduced sense of personal achievement. Burnout is often accompanied by feelings of moral distress, loss of interest and energy, and detachment from patients, colleagues and personal relatives. With the recent rapid expansion in global healthcare systems in response to societal changes, rates of physician burnout have been on the rise. It is estimated that 54% of physicians in the United States suffer from professional burnout, a 2-fold higher prevalence than that estimated for the general working population of 28%.

Burnout has serious negative implications on the physical health and wellbeing of individuals. In recent studies, burnout was associated with higher incidence of coronary heart disease and hospitalization from cardiovascular causes. Additionally, burnout was found to be an independent risk factor for type 2 diabetes mellitus and hypercholesterolemia (total cholesterol ≥220 mg/dl). Higher incidence of musculoskeletal pain and pain-related disability were also reported amongst subjects with high burnout. Excessive fatigue, insomnia, headaches, gastrointestinal and respiratory issues were all positively correlated with burnout level. More strikingly, burnout was found to be a significant predictor of mortality in those below the age of 45-years.

Burnout carries its repercussions on mental health as well. In a study of 2,555 dentists, burnout was a significant predictor of depression occurrence during the 3-year follow-up period. Increased psychotropic and antidepressant use was associated with high burnout, with a stronger correlation observed for men than women. High level of burnout was also linked to increased risk of anxiety, substance abuse, alcohol abuse, and even suicidal ideation.

Burnout is a serious threat to the medical profession at large. With more than half of the US physicians suffering from professional burnout, its implications ripple through the entirety of the healthcare system. Burnout decreases both patient care quality and physician productivity. Increased sickness absences have been reported in high burnout. In a recent report, severe burnout independently accounted for 52 sickness absences in a 2-year follow-up period. Additionally, burnout has resulted in more physicians leaving practices or reducing their work hours. A healthcare system loses on average $500,000 to $1,000,000 with the departure of a physician, in addition to the ever-increasing workload of physicians who remain in practice. Most significant of all, burnout leads to major medical errors. With the estimated 250,000 deaths in the United States occurring due to medical errors, developing effective strategies to eliminate physician burnout has become an ever-present priority.

A number of prospective studies and clinical trials have been conducted to assess the efficacy of different interventions on mitigating physician burnout. A major cluster of these studies have focused on behavioral interventions, more specifically, mindfulness-based approaches aimed at reducing the mental and emotional repercussions of burnout. Such behavioral interventions included practices of contemplation-meditation exercises, discussions on enhancing self-care and intensification of present-moment awareness. Efficacy in the latter studies was mostly assessed via quantification of change in burnout and stress-related scores, most notably the Maslach Burnout Inventory score, a well-established tool for assessment of burnout in the occupational setting. The majority of these studies reported favorable effects on burnout scores. However, limited to no-data exist on the physiological and biochemical effects of mindfulness-based interventions on physician burnout.

A second cluster of studies implemented lifestyle changes, more specifically, incentivized exercise programs and nutritional counseling for burnout. However, studies examining the effects of physical activity tended to be short in duration, of small magnitude, and lacked adequate assessment of the physiological and biochemical effects of exercise on burnout [23]. Additionally, a significant lack of research on nutritional and dietary interventions in physician burnout exist in the literature, despite the vitality of good nutrition in the health and wellbeing of physicians.

Therefore, this study intends to tackle the issue of physician burnout via a wide-lens approach, integrating both mindfulness-based training and nutritional counseling in the management of professional burnout. The effects of the interventions will be evaluated through assessment of changes in physiological and biochemical parameters known to be adversely affected in burnout, in addition to the standardized Professional Fulfillment Inventory, at 3-6 months post-intervention.

Being tested
Mindfulness training, Nutritional consult
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 trainingBehavioural

    Mindfulness training

  • Nutritional consultBehavioural

    Nutrition counseling and development of a personalized nutrition plan

Study groups in NCT04336436
Study groupRoleWhat they receive
Mindfulness Training and Nutrition CounselingExperimentalBaseline and 3-6 month follow up visits will be arranged for all participants. Visits will be conducted at baseline prior to initiation of mindfulness training and nutrition counseling, and at the 3-6 month follow up. Clinical and laboratory assessments will be obtained at each visit.
Receives: Behavioral: Mindfulness training; Behavioral: Nutritional consult

What is being measured

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

  1. Change in Professional Fulfillment Index (PFI) score

    Measured at baseline and at 3-6 months for each participant to determine if intervention was effective. A higher score indicates improvement.

    Measured: 3-6 months

  2. Change in Neff Self-Compassion Scale score

    Measured at baseline and at 3-6 months for each participant to determine if intervention was effective. A higher score indicates improvement.

    Measured: 3-6 months

Secondary outcomes (14)
  1. Blood pressure

    Change in diastolic and systolic blood pressure between baseline and 3-6 months after intervention

    Measured: 3-6 months

  2. Resting heart rate

    Change in resting heart rate between baseline and 3-6 months after intervention

    Measured: 3-6 months

  3. Weight

    Change in weight between baseline and 3-6 months after intervention

    Measured: 3-6 months

  4. Athens Insomnia Scale

    Change in insomnia scale between baseline and 3-6 months after intervention. Range from 0-24 with lower score being favorable outcome.

    Measured: 3-6 months

  5. Daily average time spent reviewing electronic health records

    Self reported time spent (in hours) reviewing electronic health records

    Measured: 3-6 months

  6. Total Cholesterol

    Change in total cholesterol post-intervention

    Measured: 3-6 months

  7. Hemoglobin A1c

    Change in HbA1c post-intervention

    Measured: 3-6 months

  8. Fasting plasma glucose

    Change in fasting plasma glucose post-intervention

    Measured: 3-6 months

  9. Fasting insulin

    Change in fasting insulin value post-intervention

    Measured: 3-6 months

  10. C-reactive protein

    Change in C-reactive protein levels post-intervention

    Measured: 3-6 months

  11. Insulin Resistance

    Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) to assess presence of and extent of insulin resistance

    Measured: 3-6 months

  12. High density lipoprotein (HDL)

    Change in HDL value post-intervention

    Measured: 3-6 months

  13. Low density lipoprotein (LDL)

    Change in LDL value post-intervention

    Measured: 3-6 months

  14. Triglycerides

    Change in triglycerides post-intervention

    Measured: 3-6 months

Timeline

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

  1. First posted7 Apr 2020
  2. Study start20 Dec 2019
  3. Primary completion7 Oct 2020
  4. Study completion31 Dec 2020

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
All participants will receive mindfulness based training and nutritional consultation.
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04336436
Sponsor's protocol ID
19-1378
Status last verified
Dec 2024
First submitted
3 Apr 2020
Last updated
31 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ahola K, Hakanen J. Job strain, burnout, and depressive symptoms: a prospective study among dentists. J Affect Disord. 2007 Dec;104(1-3):103-10. doi: 10.1016/j.jad.2007.03.004. Epub 2007 Apr 19.

    PubMed 17448543
  • Fred HL, Scheid MS. Physician Burnout: Causes, Consequences, and (?) Cures. Tex Heart Inst J. 2018 Aug 1;45(4):198-202. doi: 10.14503/THIJ-18-6842. eCollection 2018 Aug. No abstract available.

    PubMed 30374225
  • Rothenberger DA. Physician Burnout and Well-Being: A Systematic Review and Framework for Action. Dis Colon Rectum. 2017 Jun;60(6):567-576. doi: 10.1097/DCR.0000000000000844.

    PubMed 28481850
  • Pantenburg B, Luppa M, Konig HH, Riedel-Heller SG. Burnout among young physicians and its association with physicians' wishes to leave: results of a survey in Saxony, Germany. J Occup Med Toxicol. 2016 Jan 22;11:2. doi: 10.1186/s12995-016-0091-z. eCollection 2016.

    PubMed 26807138
  • Dyrbye L, Shanafelt T. A narrative review on burnout experienced by medical students and residents. Med Educ. 2016 Jan;50(1):132-49. doi: 10.1111/medu.12927.

    PubMed 26695473

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness training and Nutritional consult in people with Burnout, Professional, run by The Cleveland Clinic at 1 site in United States.

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 3 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 31 Dec 2024. 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 United States. 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?

Change in Professional Fulfillment Index (PFI) score (time frame: 3-6 months). 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 NCT04336436, which also lists 5 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 31 Dec 2024.

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