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NCT Number: NCT04336436

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

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Mindfulness Training

Behavioral

Mindfulness training

Nutritional consult

Behavioral

Nutrition counseling and development of a personalized nutrition plan

Primary outcomes

  1. Change in Professional Fulfillment Index (PFI) score

    Time frame: 3-6 months

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

  2. Change in Neff Self-Compassion Scale score

    Time frame: 3-6 months

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

Secondary outcomes

  1. Blood pressure

    Time frame: 3-6 months

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

  2. Resting heart rate

    Time frame: 3-6 months

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

  3. Weight

    Time frame: 3-6 months

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

  4. Athens Insomnia Scale

    Time frame: 3-6 months

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

  5. Daily average time spent reviewing electronic health records

    Time frame: 3-6 months

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

  6. Total Cholesterol

    Time frame: 3-6 months

    Change in total cholesterol post-intervention

  7. Hemoglobin A1c

    Time frame: 3-6 months

    Change in HbA1c post-intervention

  8. Fasting plasma glucose

    Time frame: 3-6 months

    Change in fasting plasma glucose post-intervention

  9. Fasting insulin

    Time frame: 3-6 months

    Change in fasting insulin value post-intervention

  10. C-reactive protein

    Time frame: 3-6 months

    Change in C-reactive protein levels post-intervention

  11. Insulin Resistance

    Time frame: 3-6 months

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

  12. High density lipoprotein (HDL)

    Time frame: 3-6 months

    Change in HDL value post-intervention

  13. Low density lipoprotein (LDL)

    Time frame: 3-6 months

    Change in LDL value post-intervention

  14. Triglycerides

    Time frame: 3-6 months

    Change in triglycerides post-intervention

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 7, 2020
Registry last updated
Dec 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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