Clinical trial NCT06149156: Resident Well-being and Performance
Official title: Efficacy of a Mobile Health Mindfulness-based Intervention on Resident Well-being and Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burnout, Psychological
Keywords: Residency
Well-being
Physician Health
Physician Burnout
Mindfulness
Mobile health
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2023-11-28
Enrollment: 508
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project aims to investigate the effectiveness of a meditation intervention utilizing a smart phone-based meditation app on resident burnout, well-being, and performance self-efficacy in a randomized clinical trial. 500 participants will be enrolled for a 4 week intervention.

Detailed description: Burnout is an increasingly prevalent challenge in the medical field and especially prominent in residency. Burnout negatively affects learning and decision-making, physician performance, and patient outcomes. Studies have shown that mindfulness-based interventions are effective at reducing burnout and strengthening well-being in physicians. Furthermore, mobile health mindfulness-based interventions have similar benefits to in-person interventions while offering the advantages of increased scalability, lack of physical constraint, and lower costs. This project will use a novel mobile health MBI and measure resident burnout, well-being, and self-efficacy in performance.

Eligibility criteria: Inclusion Criteria:

* Resident in a high burnout rate specialty: family medicine, internal medicine, obstetrics and gynecology, emergency medicine, general surgery, or surgical sub-specialty (plastic surgery, urology, neurosurgery, orthopedic surgery, vascular surgery, cardiothoracic surgery, otolaryngology, ophthalmology)

Exclusion Criteria:

* Participants who have previously used the HMP (a version of HMP has been freely available to the public since 2020)
* Participants who have been practicing meditation daily or almost daily for the prior six months

Primary outcomes:
measure: Change in Stress Measured by the Perceived Stress Scale
timeFrame: baseline, week 1, week 2, week 3, week 4, 3 months
Secondary outcomes:
measure: Change in Burnout Measured by the Abbreviated Maslach Burnout Inventory: Personal Accomplishment Dimension
timeFrame: baseline, 4 weeks, 3 months
measure: Change in Burnout Measured by the Abbreviated Maslach Burnout Inventory: Depersonalization and Emotional Exhaustion Dimensions
timeFrame: baseline, 4 weeks, 3 months
measure: Change in Flourishing Measured by the Flourishing Index Score
timeFrame: baseline, 4 weeks, 3 months
measure: Change in Resilience Measured by the Brief Resilience SCale
timeFrame: baseline, 4 weeks, 3 months
measure: Change in Sleep Disturbance Measured by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score
timeFrame: baseline, 4 weeks, 3 months
measure: Change in Awareness Measured by Five Facet Mindfulness Questionnaire Acting with Awareness Subscale Score
timeFrame: baseline, 4 weeks, 3 months
measure: Change in Healthy Minds Index (HM Index)
timeFrame: baseline, week 1, week 2, week 3, week 4, 3 months
measure: Change in General Self-Efficacy Measured by the General Self-Efficacy Scale
timeFrame: baseline, 4 weeks, 3 months
measure: Change in Self-efficacy of Performance Measured by self-report on Accreditation Council for Graduate Medical Education (ACGME) Residency Milestones
timeFrame: baseline, 4 weeks, 3 months
measure: Change in Connection Measured by NIH Toolbox Loneliness Score
timeFrame: baseline, 4 weeks, 3 months
measure: Change in Meaning in Life Measured by NIH Toolbox Meaning and Purpose Score
timeFrame: baseline, 4 weeks, 3 months
Other outcomes:
measure: Change in Digital Working Alliance Inventory
timeFrame: 4 weeks
measure: Acceptability, Appropriateness, and Feasibility of Intervention
timeFrame: 4 weeks
Locations:
city: Madison
country: United States
facility: University of Wisconsin School of Medicine and Public Health
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Simon Goldberg
role: PRINCIPAL_INVESTIGATOR
References: