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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Burnout, Professional
- 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 group | Role | What they receive |
|---|---|---|
| Mindfulness Training and Nutrition Counseling | Experimental | Baseline 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.
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
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)
Blood pressure
Change in diastolic and systolic blood pressure between baseline and 3-6 months after intervention
Measured: 3-6 months
Resting heart rate
Change in resting heart rate between baseline and 3-6 months after intervention
Measured: 3-6 months
Weight
Change in weight between baseline and 3-6 months after intervention
Measured: 3-6 months
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
Daily average time spent reviewing electronic health records
Self reported time spent (in hours) reviewing electronic health records
Measured: 3-6 months
Total Cholesterol
Change in total cholesterol post-intervention
Measured: 3-6 months
Hemoglobin A1c
Change in HbA1c post-intervention
Measured: 3-6 months
Fasting plasma glucose
Change in fasting plasma glucose post-intervention
Measured: 3-6 months
Fasting insulin
Change in fasting insulin value post-intervention
Measured: 3-6 months
C-reactive protein
Change in C-reactive protein levels post-intervention
Measured: 3-6 months
Insulin Resistance
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) to assess presence of and extent of insulin resistance
Measured: 3-6 months
High density lipoprotein (HDL)
Change in HDL value post-intervention
Measured: 3-6 months
Low density lipoprotein (LDL)
Change in LDL value post-intervention
Measured: 3-6 months
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.
- First posted7 Apr 2020
- Study start20 Dec 2019
- Primary completion7 Oct 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Burnout, ProfessionalStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- 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
- 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)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Betul Hatipoglu, MD, Principal investigator, Staff Physician
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 17448543Fred 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 30374225Rothenberger 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 28481850Pantenburg 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 26807138Dyrbye 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
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Combined Mindfulness-Based Interventions and Nutritional Counseling on Physician Burnout: A Clinical Trial
- ClinicalTrials.gov ID
- NCT04336436
- Acronym / sponsor ID
- 19-1378
- Conditions
- Burnout, Professional
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- 20 Dec 2019 (actual)
- Primary completion
- 7 Oct 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 7 Apr 2020 (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.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive mindfulness based training and nutritional consultation.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Training and Nutrition Counseling | Experimental | Behavioral: Mindfulness training, Behavioral: Nutritional consultBaseline 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Physician employed by Cleveland Clinic
- Located in Ohio
- Must anticipate remaining employed for at least 6 months post-enrollment
Key exclusion criteria (4 listed)
- 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
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 trainingMindfulness training | Behavioural | Mindfulness Training and Nutrition Counseling |
| Nutritional consultNutrition counseling and development of a personalized nutrition plan | Behavioural | Mindfulness Training and Nutrition Counseling |
Primary outcome
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.
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.
14 secondary outcomes
Blood pressure
Time frame: 3-6 months
Resting heart rate
Time frame: 3-6 months
Weight
Time frame: 3-6 months
Athens Insomnia Scale
Time frame: 3-6 months
Daily average time spent reviewing electronic health records
Time frame: 3-6 months
Total Cholesterol
Time frame: 3-6 months
Hemoglobin A1c
Time frame: 3-6 months
Fasting plasma glucose
Time frame: 3-6 months
Fasting insulin
Time frame: 3-6 months
C-reactive protein
Time frame: 3-6 months
Insulin Resistance
Time frame: 3-6 months
High density lipoprotein (HDL)
Time frame: 3-6 months
Low density lipoprotein (LDL)
Time frame: 3-6 months
Triglycerides
Time frame: 3-6 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 31 Dec 2024.
- Background: PubMed 17448543Ahola 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.
- Background: PubMed 30374225Fred 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.
- Background: PubMed 28481850Rothenberger 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.
- Background: PubMed 26807138Pantenburg 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.
- Background: PubMed 26695473Dyrbye 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.
- 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.
Betul Hatipoglu, MD principal investigator
Staff Physician
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 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.