NCT03514862

Brief Summary

In this project, the investigators propose to evaluate the impact of a Mindfulness-Based Intervention (MBI) Program on the well-being of University of Miami (UM) clinicians and faculty/staff. If successfully implemented and proven to be effective, this training program may be disseminated to other interested medical personnel.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 29, 2018

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

May 2, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 27, 2018

Completed
Last Updated

February 12, 2019

Status Verified

February 1, 2019

Enrollment Period

8 months

First QC Date

April 20, 2018

Last Update Submit

February 11, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in measure of stress

    Stress will be measured using the Perceived Stress Scale, a short-form 4 item scale with a range of 0 to 16, with higher scores representing greater stress. Baseline responses will be compared to 4-week assessment responses of the control and intervention groups. Results between the control and intervention groups will be compared for statistical significance.

    Baseline, 4-weeks, 3-months, 6-months

Secondary Outcomes (1)

  • Change in measure of burnout

    Baseline, 4-weeks, 3-months, 6-months

Study Arms (2)

Intervention

EXPERIMENTAL

Participants will participate in 4 weeks of the Mindfulness-Based Intervention (MBI) and then will be invited to continue to participate in 4 additional Mindfulness Booster Training.

Behavioral: Mindfulness Booster TrainingBehavioral: Mindfulness-Based Intervention (MBI)

Control

ACTIVE COMPARATOR

Participants will participate in 4 weeks of the Mindfulness-Based Intervention (MBI) and then continue to Self-Practice for 4 weeks.

Behavioral: Mindfulness Booster TrainingBehavioral: Self-Practice

Interventions

Four additional mindfulness booster sessions after the 4-week MBI program.

ControlIntervention

MBI program is delivered once a week for 4 weeks, 90 minutes each preceded by a 90-minute orientation session. The training sessions will include discussion, and introduction and practice of mindfulness practices.

Intervention
Self-PracticeBEHAVIORAL

4 weeks of self-practice after the MBI training.

Control

Eligibility Criteria

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

You may qualify if:

  • Medical faculty, fellows, residents, and other allied healthcare providers at UM Miller School of Medicine and Jackson will be eligible for participation in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Burnout, Professional

Condition Hierarchy (Ancestors)

Occupational StressOccupational DiseasesBurnout, PsychologicalStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • David J Lee, PhD

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 20, 2018

First Posted

May 2, 2018

Study Start

March 29, 2018

Primary Completion

November 27, 2018

Study Completion

November 27, 2018

Last Updated

February 12, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations