NCT06734767

Brief Summary

The study team is seeking to evaluate the efficacy of the Mindfulness Based Stress Reduction (MBSR) course at reducing stress and burnout. This will be done through the collection of brief anonymous online surveys (the Perceived Stress Scale and the Mini Z) before the MBSR course and at 2 weeks, 6 months, and 12 months following the end of the course. Participation is completely voluntary and will not affect anyone's ability to take this course, and the course instructors will have no knowledge of who has or has not participated in the study.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
55mo left

Started Mar 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress33%
Mar 2024Dec 2030

Study Start

First participant enrolled

March 28, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 16, 2024

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

April 20, 2025

Status Verified

April 1, 2025

Enrollment Period

6.8 years

First QC Date

December 10, 2024

Last Update Submit

April 18, 2025

Conditions

Keywords

BurnoutMBSRmindfulnessphysician well-being

Outcome Measures

Primary Outcomes (1)

  • Perceived Stress Scale (PSS)

    The Perceived Stress Scale (PSS) is a validated 10-question survey tool that evaluates an individual's stress level. Each question is scored from 0-4 - Full scale range from 0-40, with higher score indicating higher perceived stress.

    Baseline and at 2 weeks, 6 months, and 12 months following the end of the course (course is 8 weeks)

Secondary Outcomes (2)

  • The "Mini Z" survey

    Baseline and at 2 weeks, 6 months, and 12 months following the end of the course (course is 8 weeks)

  • Burnout questions

    Baseline and at 2 weeks, 6 months, and 12 months following the end of the course (course is 8 weeks)

Study Arms (2)

Mindfulness Based Stress Reduction course faculty participants

OTHER

Faculty physicians who have chosen to take the free 8-week course are offered the opportunity to anonymously enroll in the study.

Behavioral: Mindfulness Based Stress Reduction 8-week course

Mindfulness Based Stress Reduction course trainee participants

OTHER

Trainee physicians who have chosen to take the free 8-week course are offered the opportunity to anonymously enroll in the study.

Behavioral: Mindfulness Based Stress Reduction 8-week course

Interventions

The Mindfulness Based Stress Reduction (MBSR) 8-week course is an evidence-based curriculum that has been taught for over 40 years and is offered world-wide, teaching mindfulness skills and practices such as meditation.

Mindfulness Based Stress Reduction course faculty participantsMindfulness Based Stress Reduction course trainee participants

Eligibility Criteria

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

You may qualify if:

  • \- A physician in The Mount Sinai Hospital System

You may not qualify if:

  • \- none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Burnout, Psychological

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

MindfulnessCognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jeffrey Zahn, MD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Course participants are offered to enroll anonymously in this survey study and are unaware of the who the study results reviewers will be.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Medical practitioners who choose to register for a free mindfulness course are evaluated for improvements in their ability to manage stress and mitigate burnout.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 10, 2024

First Posted

December 16, 2024

Study Start

March 28, 2024

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

April 20, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Surveys are filed anonymously, no identifying information of participants

Locations