NCT04336436

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 3, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 7, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

December 31, 2024

Status Verified

December 1, 2024

Enrollment Period

10 months

First QC Date

April 3, 2020

Last Update Submit

December 30, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    3-6 months

Secondary Outcomes (14)

  • Blood pressure

    3-6 months

  • Resting heart rate

    3-6 months

  • Weight

    3-6 months

  • Athens Insomnia Scale

    3-6 months

  • Daily average time spent reviewing electronic health records

    3-6 months

  • +9 more secondary outcomes

Study Arms (1)

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.

Behavioral: Mindfulness trainingBehavioral: Nutritional consult

Interventions

Mindfulness training

Mindfulness Training and Nutrition Counseling

Nutrition counseling and development of a personalized nutrition plan

Mindfulness Training and Nutrition Counseling

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (5)

  • 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.

    PMID: 17448543BACKGROUND
  • 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.

    PMID: 30374225BACKGROUND
  • 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.

    PMID: 28481850BACKGROUND
  • 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.

    PMID: 26807138BACKGROUND
  • 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.

    PMID: 26695473BACKGROUND

MeSH Terms

Conditions

Burnout, Professional

Condition Hierarchy (Ancestors)

Occupational StressOccupational DiseasesBurnout, PsychologicalStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Betul Hatipoglu, MD

    Staff Physician

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All participants will receive mindfulness based training and nutritional consultation.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 3, 2020

First Posted

April 7, 2020

Study Start

December 20, 2019

Primary Completion

October 7, 2020

Study Completion

December 31, 2020

Last Updated

December 31, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations