Clinical trial NCT03714204: Effects of Transcendental Meditation on Physician Burnout and Depression
Official title: Effects of Transcendental Meditation on Physician Burnout and Depression: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burnout, Professional
Depression
Insomnia
Perceived Stress
Resilience
Keywords: academic physician burnout
physician burnout
Intervention to reduce physician burnout
physician depression
physician insomnia
physician stress
Transcendental Meditation
TM
Lead sponsor: Maharishi International University
Sponsor class: OTHER
Collaborators: name: Loyola University Chicago
First posted: 2018-10-22
Enrollment: 40
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled trial
Primary purpose: PREVENTION

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.

Detailed description: Burnout is pervasive among physicians in academia, with costly ramifications for individuals and institutions ($100,000-900,000/faculty replacement). The purpose of this study is to assess, both quantitatively and qualitatively, the effects of the TM technique as an intervention in lowering burnout, depression, perceived stress, insomnia, and to increase resilience in academic physicians.

Research Study Hypotheses Quantitative hypothesis #1: Regular practice of the TM technique by academic physicians for 4 months will reduce symptoms of burnout compared to academic physicians not practicing the TM technique Quantitative hypothesis #2: Regular practice of the TM technique by academic physicians for 4 months will reduce symptoms of perceived stress, insomnia, depression and increase resilience compared to academic physicians not practicing the TM technique.

Qualitative research questions:

1. What are the daily challenges faced by academic physicians and how do they view their ability to handle them?
2. Does regular practice of the TM technique improve their perception of their quality of life with regards to the challenges they face?

Sample Size Estimate There is an effect size of .6225 when using changed scores for treatment and control groups, and their respective standard deviations, from a recent study using the TM technique as the intervention and measuring burnout using the Maslach Burnout Inventory (Elder, 2014). Applying Cohen's power tables for p\<.05 to this effect size the number of subjects per group needed is 12. Recruiting 20 subjects per group will allow for 20% attrition.

Study Design Overview The research design is a mixed methods randomized controlled trial (RCT) involving both a treatment and wait-list control group. Quantitative testing will be done three times: pretest followed by posttests at one and four months. The one month posttest is to assess any short term changes as well as a precaution against possible dropouts of either group before the four-month posttest. All subjects will be required to sign an informed consent form prior to participation.

Qualitative data will be gathered through two individual 30-minute semi-structured interviews: the first (entry) before randomization, at the time of the quantitative pretest; and the second (exit) at the 4-month posttest.

The independent variable is instruction in the TM technique, which includes introductory and follow-up sessions to be taught to the treatment group following their pretest and entry interview.

Quantitative data will be analyzed using repeated measures analysis of variance. Qualitative data will be analyzed using a phenomenological approach of identifying main themes and sub themes from the pre and post intervention interviews. The interviews will be the only source of qualitative data. Separate analysis and discussions of quantitative and qualitative data will be merged together to examine their convergence and divergence.

The Institutional Review Board at Maharishi University of Management approved the study in March 2015 followed by the Institutional Review Board at Loyola University Chicago approval in July 2015.

The goal of this study is to see if the intervention alters quantitative measurements of burnout and to understand what kinds of challenges academic physicians face in their daily lives, how they view their ability to handle them, and whether either is transformed during the study period. Although much research has shown symptoms of burnout are largely present among physicians, and a few studies showed promising antidotes, none to date have made use of both quantitative and qualitative data in exploring an intervention for lowering burnout in academic physicians.

This study will employ the advanced convergent mixed methods design which entails collecting both quantitative and qualitative data at pre-and posttest intervals, while adding the advanced feature of an intervention following pretesting.

Study Protocol

* The researcher will oversee all test administration and tracking of subject compliance.
* All study related paperwork and online tests will be managed under appropriate institutional protocol for anonymity and confidentiality. Data will be securely stored appropriately on-line and the hard copies of the consent form kept under lock in the Vice-Dean of Education's office. To further protect the identity of reporting physicians, the identity of the medical school is, and will be, masked in this dissertation and further papers based on this dissertation.

Adverse event reporting: If an adverse event is reported through testing or interviews (and it is a recent issue) it will be reported to the Principal Investigator who will speak to this potential study participant and recommend that they be seen in Employee Health. If the adverse event was suicidal ideation they would be excluded from the study until such time the event was resolved.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria: current suicidal ideation, previous instruction in the TM technique

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Primary outcomes:
measure: Maslach Burnout Inventory
timeFrame: change from baseline burnout level at four months
Secondary outcomes:
measure: Beck Depression Inventory
timeFrame: change from baseline depression level at four months
measure: Insomnia Severity Index
timeFrame: change from baseline insomnia level at four months
measure: Perceived Stress Scale
timeFrame: change from baseline perceived stress level at four months
measure: Brief Resilience Inventory
timeFrame: change from baseline resilience level at four months
Other outcomes:
measure: Personal Interview with researcher
timeFrame: baseline, 4-months
Locations:
city: Maywood
country: United States
facility: Loyola University Stritch School of Medicine
state: Illinois
Study officials:
affiliation: Outside Researcher
name: Marie Loiselle, PhD
role: STUDY_CHAIR
affiliation: Vice-Dean of Education
name: Gregory Gruener, MD
role: STUDY_DIRECTOR
affiliation: Adjunct Professor
name: Carla L Brown, PhD
role: PRINCIPAL_INVESTIGATOR
References: