Burnout, ProfessionalNCT03714204
Effects of Transcendental Meditation on Physician Burnout and Depression
A study testing Transcendental Meditation technique in people with Burnout, Professional and Depression, run by Marie Loiselle at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burnout, Professional, Depression, Insomnia
- What is being tested?
- Transcendental Meditation technique
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2015to 30 Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Loyola University Stritch School of Medicine
Maywood, Illinois, 60153
About this study
Official title: Effects of Transcendental Meditation on Physician Burnout and Depression: A Randomized Controlled Trial
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.
Read the 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:
- What are the daily challenges faced by academic physicians and how do they view their ability to handle them?
- 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.
- Conditions
- Burnout, Professional, Depression, Insomnia, Perceived Stress, Resilience
- Being tested
- Transcendental Meditation technique
- Keywords
- academic physician burnout, physician burnout, Intervention to reduce physician burnout, physician depression, physician insomnia, physician stress, Transcendental Meditation, TM
- Medical subject headings
- Burnout, Professional, Depression, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcendental Meditation techniqueBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Transcendental Meditation technique |
| Control Group | No intervention | Participants assigned to this group served as wait-list controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maslach Burnout Inventory
measures burnout level
Measured: change from baseline burnout level at four months
Secondary outcomes (4)
Beck Depression Inventory
measures depression level
Measured: change from baseline depression level at four months
Insomnia Severity Index
measures insomnia level
Measured: change from baseline insomnia level at four months
Perceived Stress Scale
measures level of perceived stress
Measured: change from baseline perceived stress level at four months
Brief Resilience Inventory
measures resilience level
Measured: change from baseline resilience level at four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2018
- Study start1 Aug 2015
- Primary completion30 Jun 2016
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burnout, ProfessionalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marie Loiselle
- Sponsor type
- University, hospital or other
- Collaborators
- Loyola University Chicago
- Responsible party
- Sponsor-investigator, Marie Loiselle, Maharishi International University
- Investigators
- Marie Loiselle, PhD, Study chair, Outside ResearcherGregory Gruener, MD, Study director, Vice-Dean of EducationCarla L Brown, PhD, Principal investigator, Adjunct Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03714204
- Sponsor's protocol ID
- 1080108
- Status last verified
- Oct 2023
- First submitted
- 12 Oct 2018
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcendental Meditation on Physician Burnout and Depression: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03714204
- Acronym / sponsor ID
- 1080108
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Marie LoiselleUniversity, hospital or other
- Collaborators
- Loyola University Chicago
- Study start
- 1 Aug 2015 (actual)
- Primary completion
- 30 Jun 2016 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 22 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- What are the daily challenges faced by academic physicians and how do they view their ability to handle them?
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Transcendental Meditation Group | Experimental | Behavioral: Transcendental Meditation techniqueParticipants 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. |
| Control Group | No intervention | –Participants assigned to this group served as wait-list controls |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcendental Meditation techniqueThe 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. | Behavioural | Transcendental Meditation Group |
Primary outcome
Maslach Burnout Inventory
Time frame: change from baseline burnout level at four months
measures burnout level
4 secondary outcomes
Beck Depression Inventory
Time frame: change from baseline depression level at four months
Insomnia Severity Index
Time frame: change from baseline insomnia level at four months
Perceived Stress Scale
Time frame: change from baseline perceived stress level at four months
Brief Resilience Inventory
Time frame: change from baseline resilience level at four months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Individual participant dataSharing planned: Yes. all that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marie Loiselle, PhD study chair
Outside Researcher
Gregory Gruener, MD study director
Vice-Dean of Education
Carla L Brown, PhD principal investigator
Adjunct Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcendental Meditation technique in people with Burnout, Professional and Depression, run by Marie Loiselle at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maslach Burnout Inventory (time frame: change from baseline burnout level at four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.