NCT03811990

Brief Summary

Emergency medicine is notorious for its high rate of burnout and mental health issues. The emergency department (ED) is a high paced work environment dealing with life and death issues. Employees in the ED work shift times that are not conducive to a natural circadian rhythm. All of these factors lead to high rates of burnout and overall dissatisfaction with their career choice. These are known downsides of a career in emergency medicine, but little effort is put into addressing this issue in everyday EDs. Cell phones offer an easy and convenient means to participate in meditation. There are multiple evidence-based meditation apps available to cell phone users free of charge. Meditation has been shown to decrease burnout, rates of depression, and rates of anxiety. We hypothesize that weekly use of a meditation-based cell phone application will improve the mental health of emergency department employees as measured on various wellness inventories.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
unknown

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 19, 2018

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 22, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

January 24, 2019

Status Verified

January 1, 2019

Enrollment Period

8 months

First QC Date

January 16, 2019

Last Update Submit

January 22, 2019

Conditions

Outcome Measures

Primary Outcomes (4)

  • Change in depression score

    Beck Depression Inventory, numeric score of 0-63 with a score of 63 being the most depressed

    90 and 180 days

  • Change in anxiety score

    Beck Anxiety Inventory, numeric score of 0-63 with a score of 63 being the most anxious

    90 and 180 days

  • Change in stress levels

    Perceived Stress Scale, numeric score of 0-40 with a score of 40 being the most stressed

    90 and 180 days

  • Change in burnout level

    Maslach Burnout Inventory, measures level of stress on a numeric scale

    90 and 180 days, numeric scale between 0 and 6 with 6 being the highest score

Study Arms (2)

Control

NO INTERVENTION

Intervention

ACTIVE COMPARATOR
Behavioral: Cleveland Clinic Stress Free Now Meditations For Healers

Interventions

Phone-based meditation application

Intervention

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Employment in the Emergency Department (with at least 8 shifts a month at Dell Seton Medical Center or Seton Medical Center) as either an attending physician, resident physician, or nurse
  • Age greater than/equal to 18 years old and younger than 75 years old
  • Must own a mobile phone operating on the iOS system

You may not qualify if:

  • Already use a phone-based meditation app on a weekly basis
  • Currently undergoing psychological treatment in the form of weekly therapy or psychotropic medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Austin

Austin, Texas, 78701, United States

RECRUITING

Related Publications (1)

  • Coulon SM, Monroe CM, West DS. A Systematic, Multi-domain Review of Mobile Smartphone Apps for Evidence-Based Stress Management. Am J Prev Med. 2016 Jul;51(1):95-105. doi: 10.1016/j.amepre.2016.01.026. Epub 2016 Mar 15.

    PMID: 26993534BACKGROUND

MeSH Terms

Conditions

Burnout, ProfessionalDepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Occupational StressOccupational DiseasesBurnout, PsychologicalStress, PsychologicalBehavioral SymptomsBehaviorMental Disorders

Study Officials

  • Keith Lambert, MD

    University of Texas at Austin

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Keith Lambert, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized, non-blinded, control trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2019

First Posted

January 22, 2019

Study Start

December 19, 2018

Primary Completion

August 1, 2019

Study Completion

June 1, 2020

Last Updated

January 24, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations