NCT03714204

Brief Summary

This research study will examine the effects of the Transcendental Meditation (TM) technique on academic physician burnout, depression, insomnia, perceived stress, and resilience through a mixed methods approach.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2015

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

August 1, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2016

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2016

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

October 12, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

October 22, 2018

Completed
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

11 months

First QC Date

October 12, 2018

Last Update Submit

October 17, 2023

Conditions

Keywords

academic physician burnoutphysician burnoutIntervention to reduce physician burnoutphysician depressionphysician insomniaphysician stressTranscendental MeditationTM

Outcome Measures

Primary Outcomes (1)

  • Maslach Burnout Inventory

    measures burnout level

    change from baseline burnout level at four months

Secondary Outcomes (4)

  • Beck Depression Inventory

    change from baseline depression level at four months

  • Insomnia Severity Index

    change from baseline insomnia level at four months

  • Perceived Stress Scale

    change from baseline perceived stress level at four months

  • Brief Resilience Inventory

    change from baseline resilience level at four months

Other Outcomes (1)

  • Personal Interview with researcher

    baseline, 4-months

Study Arms (2)

Transcendental Meditation Group

EXPERIMENTAL

Participants assigned to this group each received the intervention of 5 initial class instructions in the Transcendental Meditation technique, followed by 6 additional classes over the 4-month study period. Group participants were expected to practice the technique for 20 minutes twice per day for 4-months.

Behavioral: Transcendental Meditation technique

Control Group

NO INTERVENTION

Participants assigned to this group served as wait-list controls

Interventions

The TM technique is a simple mental procedure that is categorized in the automatic self-transcending category of meditation practices. It is automatic in that it does not involve any concentration or control. It allows the mental activity to settle down in a spontaneous and natural manner during a process called transcending, or going beyond, until it reaches a state beyond conscious thinking. Correspondingly, the body settles down to a deep state of rest which allows stress to dissolve and the nervous system to rejuvenate The effortless nature of the TM practice coupled with the vast research supporting its efficacy, its systematic standardized teaching program and the fact that it does not involve any belief or change in one's lifestyle made it the choice intervention for this research.

Transcendental Meditation Group

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have an MD degree
  • Be an academic attending physician at the Loyola Chicago School of Medicine or Edward Hines, Jr. VA Hospital
  • Commit to attend all required sessions for learning the Transcendental Meditation (TM)technique and monthly follow-ups
  • Agree to practice TM twice daily for 20 minutes for the 4-month study period
  • Agree to complete both pre-and post-testing (at 1-month and 4-months) including both the entry and exit interviews.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loyola University Stritch School of Medicine

Maywood, Illinois, 60153, United States

Location

MeSH Terms

Conditions

Burnout, ProfessionalDepressionSleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Occupational StressOccupational DiseasesBurnout, PsychologicalStress, PsychologicalBehavioral SymptomsBehaviorSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental Disorders

Study Officials

  • Marie Loiselle, PhD

    Outside Researcher

    STUDY CHAIR
  • Gregory Gruener, MD

    Vice-Dean of Education

    STUDY DIRECTOR
  • Carla L Brown, PhD

    Adjunct Professor

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
The names of individual participants
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

October 12, 2018

First Posted

October 22, 2018

Study Start

August 1, 2015

Primary Completion

June 30, 2016

Study Completion

September 30, 2016

Last Updated

October 19, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

all that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
Will be available six months after publication
Access Criteria
To be determined

Locations