AzTrials
AzTrials

Burnout, ProfessionalNCT04586309

Improving the Mental Health of Resident Physicians and Fellows Through Transcendental Meditation

A study testing Transcendental meditation in people with Burnout, Professional and Stress, Psychological, run by University of Arizona.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
Search all trials

Trial summary

This proposal aims to optimize resident physician and fellow wellness and performance at Banner University Medical Center through an evidence-based stress reduction program, Transcendental Meditation (TM). Read more about this study

Who is it for?
Any ageHealthy volunteers can take part
What is being tested?
Transcendental meditation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jun 2021to Dec 2021
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 Any age
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Full-time Resident physicians or Fellows employed by Banner Health
  • 18 years or older
  • Some participants included will have treated COVID-19 patients or be working at locations where COVID-19 patients are being treated.
  • Willing to take part in either group assignment (randomized to either immediate start or TM training, or delayed TM training)
  • Willing to complete baseline, 1-month and 3-month post- assessments
  • If being treated with psychoactive medications, the maintenance of a stable regimen for at least two months before enrollment (by self-report).

Who cannot join

  • Already instructed in the Transcendental Meditation technique
  • Currently unstable psychotic symptoms, mania or bipolar disorder as demonstrated by self-report, or psychiatric hospitalizations in the past six months;
  • Current suicidal or homicidal ideation with intent or plan.

About this study

Official title: Improving the Mental Health of Resident Physicians and Fellows : Reducing Burnout & Enhancing Resilience Through Transcendental Meditation

This proposal aims to optimize resident physician and fellow wellness and performance at Banner University Medical Center through an evidence-based stress reduction program, Transcendental Meditation (TM). It is particularly timely due to the enormous pressure and stress that residents face as front-line workers during the current 2019 novel coronavirus (COVID-19) pandemic.

Participants will be randomly assigned to the TM training (group 1), or delayed TM training (group 2). Study outcomes will be assessed at baseline and at 1 and 3 months post-training. Participants who are assigned to group 2 , will receive the TM training following the three month assessment, and then complete assessments at 1 and 3 months post-training.

These assessment tools look at anxiety (Generalized Anxiety Disorder Scale-GAD-7), depression (Patient Health Questionnaire (PHQ-9), insomnia (Pittsburgh Sleep Quality Index PSQI), psychological distress (Brief Symptom Inventory BSI18), burnout (Maslach Burnout Inventory-MBI), resilience (Conner-Davidson Resilience Scale- RISC), and alcohol use (Alcohol Use Disorder Identification Test - AUDIT).

Read the detailed description

Up to one hundred resident and fellow physicians employed by Banner Health will participate in the project. Participants will be randomly assigned to either the TM program or to a delayed TM training, treatment-as-usual control group . Study outcomes will be assessed at baseline, 1-month and 3-month post-training , with change in burnout as the primary outcome. Control subjects (aka delayed TM training or Group 2) will be eligible to learn TM after completing 3 month post-testing. Group 2 will also complete post-training assessments at 1-month and 3-months post-training. The total duration of this project will be 60 months.

Two experienced certified TM instructors will conduct the instruction. All certified TM teachers have been extensively trained in the teaching of the TM program, including teaching the course of instruction, verifying continued correctness of effortless practice of the technique, and conducting additional follow-up sessions. The same standardized TM course sequence will be used for all study participants.

Outline of Transcendental Meditation Program: TM group will involve 10 total sessions over 12 weeks (about 75 minutes per session). The core instruction in the TM technique will involve a course of instruction, taught over five sessions. The five core instruction sessions will include:

  1. Introductory session-Review of previous scientific research on the TM program and a vision of possible benefits; Preparation- discussion of the mechanics and origin of the TM technique(75 minutes- group session); After the introductory session, a Personal Interview is conducted telephonically-with a teacher of the TM program. The participant completes a brief interview form prior to the call. The interviewer (a teacher with the TM program) reviews the form with the participant. The four classes of TM instruction adhere to a standardized teaching protocol and are conducted by certified teachers of the Transcendental Meditation program trained and approved by the Transcendental Meditation organization.
  2. Personal Instruction-individual one-on-one instruction in the TM technique (75 minutes). The student learns the mechanics of the TM technique. At the conclusion of this class the student is able to meditate properly.
  3. First Day of Verification of Correct Practice and Further Instruction (90 minutes-group session); The first follow-up session provides information to help students incorporate TM into their daily life.
  4. Second Day of Verification of Correct Practice-understanding the mechanics of the TM technique from personal experiences (90 minutes-group session); The second session provides information about how the meditation reduces stress and improves health
  5. Third Day of Verification of Correct Practice-understanding the mechanics of the development of higher human potential and wellness (90 minutes-group session). The third session reviews students' experiences both during and after meditation, and provides further instruction to support their ongoing home practice.

Following the initial phase of the intervention (5 sessions), there will be 5 additional group sessions of 45-60minutes each provided once a month for the remainder of the 6-month intervention period. These sessions will include: a) discussion of personal experiences and verification of correctness of practice of the TM technique, and b) knowledge of the human potential and its relationship to mental and physical health.

Compliance with treatment sessions will be defined as attending at least 70% of the treatment sessions. Subjects randomized to the TM group will continue with their usual care.

No research data is collected during the sessions described above.

Although it is the intent for all of these sessions to be conducted at the Tucson Transcendental Meditation Center, in small physically distanced groups of participants wearing whatever level of personal protective equipment is being recommended by the CD at the time of the session, in the event that in person sessions are not possible, the group sessions will be held virtually through Zoom video conferencing. Additionally, participants may be able to complete sessions 3-5 over the TM App (a series of pre-recorded lectures).

For participants who choose to use the TM App, they will be asked to create an account through the app, and will be given the opportunity to review the Terms of Service and Privacy Policies. Maharishi Foundation International (the owners/developers of the App) monitor the participants progress through the digital content so that they know when to release the next session (as described above). Participants can also use the App to time their meditation sessions, although this is not required.

Home Practice: Home practice will consist of two 20-minute TM sessions daily - morning and evening. Compliance with TM practice will be defined as meditating at least once a day. Participants will complete a home practice questionnaire at 1 month and 3 months (attached as an addendum-will be included in the REDCap bundle with assessments).

Delayed TM training/Control Condition: Subjects randomized to the control group will continue with their usual care. Control subjects will be invited to learn the TM program after 3-month post-training assessment. If they chose to complete the TM training, they will be subject to the same training as Group 1, and the same assessments after the end of their training.

Being tested
Transcendental meditation
Keywords
transcendental meditation, resilience, burnout
Medical subject headings
Burnout, Professional, Stress, Psychological, Depression, Occupational Stress, Burnout, Psychological

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Transcendental meditationBehavioural

    Instruction in the TM technique is taught over five sessions.

    1. Introductory session-Review of previous scientific research on the TM program and a vision of possible benefits; Preparation- discussion of the mechanics and origin of the TM technique After the introductory session, a Personal Interview is conducted telephonically-with a teacher of the TM program.
    2. Personal Instruction-individual one-on-one instruction in the TM technique. The student learns the mechanics of the TM technique. At the conclusion of this class the student is able to meditate properly.
    3. First Day of Verification of Correct Practice and Further Instruction.
    4. Second Day of Verification of Correct Practice-understanding the mechanics of the TM technique from personal experiences.
    5. Third Day of Verification of Correct Practice-understanding the mechanics of the development of higher human potential and wellness.
Study groups in NCT04586309
Study groupRoleWhat they receive
Early TM TrainingExperimentalThis group will receive training in Transcendental Meditation and will complete assessments at baseline, 1 month and 3 months.(3 assessments in total).
Receives: Behavioral: Transcendental meditation
Delayed TM trainingActive comparatorThis arm will complete the baseline, 1 month and 3 month assessments and then will receive the TM training, followed by additional 1 month and 3 month post-training assessments (5 in total)
Receives: Behavioral: Transcendental meditation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Burnout

    Maslach Burnout Inventory- Participants respond to each prompt 0-6, high score in first 2 sections, low score in third may indicate risk of burnout.

    Measured: baseline

  2. Burnout

    Maslach Burnout Inventory- Participants respond to each prompt 0-6, high score in first 2 sections, low score in third may indicate risk of burnout.

    Measured: 1 month

  3. Burnout

    Maslach Burnout Inventory- Participants respond to each prompt 0-6, high score in first 2 sections, low score in third may indicate risk of burnout.

    Measured: 3 month

Secondary outcomes (18)
  1. Resilience

    Connor-Davidson Resilience Scale- Participants respond to each prompt 0-5 x 25 items, low score indicates poor resilience.

    Measured: baseline

  2. Resilience

    Connor-Davidson Resilience Scale- Participants respond to each prompt 0-5 x 25 items, low score indicates poor resilience.

    Measured: 1 month

  3. Resilience

    Connor-Davidson Resilience Scale- Participants respond to each prompt 0-5 x 25 items, low score indicates poor resilience.

    Measured: 3 months

  4. Alcohol use

    AUDIT: Alcohol Use Disorders Identification Test- Participants respond to 10 items with 0-4, higher score more concerning for alcohol use disorder.

    Measured: baseline

  5. Alcohol use

    AUDIT: Alcohol Use Disorders Identification Test- Participants respond to 10 items with 0-4, higher score more concerning for alcohol use disorder.

    Measured: 1 month

  6. Alcohol use

    AUDIT: Alcohol Use Disorders Identification Test- Participants respond to 10 items with 0-4, higher score more concerning for alcohol use disorder.

    Measured: 3 months

  7. Depression

    PHQ-9: Patient Health Questionnaire- Participants answer each prompt (not all all, some days, most days, nearly every day) higher numbers indicate greater depressive symptoms.

    Measured: baseline

  8. Depression

    PHQ-9: Patient Health Questionnaire- Participants answer each prompt (not all all, some days, most days, nearly every day) higher numbers indicate greater depressive symptoms.

    Measured: 1 month

  9. Depression

    PHQ-9: Patient Health Questionnaire- Participants answer each prompt (not all all, some days, most days, nearly every day) higher numbers indicate greater depressive symptoms.

    Measured: 3 months

  10. Sleep Quality

    PSQI: Pittsburgh Sleep Quality Index- Participant answers 19 questions in 7 sections, Seven sections are combined for global score of 0-21 where ) is no problems and 21 is problems in all areas.

    Measured: baseline

  11. Sleep Quality

    PSQI: Pittsburgh Sleep Quality Index- Participant answers 19 questions in 7 sections, Seven sections are combined for global score of 0-21 where ) is no problems and 21 is problems in all areas.

    Measured: 1 month

  12. Sleep Quality

    PSQI: Pittsburgh Sleep Quality Index- Participant answers 19 questions in 7 sections, Seven sections are combined for global score of 0-21 where ) is no problems and 21 is problems in all areas.

    Measured: 3 months

  13. Distress

    BSI18: Brief Symptom Inventory 18- Participants answer 18 questions on 0-4 scale. Higher numbers indicate more distress.

    Measured: baseline

  14. Distress

    BSI18: Brief Symptom Inventory 18

    Measured: 1 month

  15. Distress

    BSI18: Brief Symptom Inventory 18

    Measured: 3 months

  16. Anxiety

    GAD7: Generalized Anxiety Disorder 7- Participants answer 7 questions 0-3. Higher scores indicate greater anxiety,

    Measured: baseline

  17. Anxiety

    GAD7: Generalized Anxiety Disorder 7- Participants answer 7 questions 0-3. Higher scores indicate greater anxiety,

    Measured: 1 month

  18. Anxiety

    GAD7: Generalized Anxiety Disorder 7- Participants answer 7 questions 0-3. Higher scores indicate greater anxiety,

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2020
  2. Study startJun 2021 (estimated)
  3. Primary completionJun 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Why it stopped: Feasibility

Resources

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
Supportive care
Allocation
Randomised
Intervention model
Crossover
Model description
Participants will be randomly assigned to the TM training (group 1), or delayed TM training (group 2). Study outcomes will be assessed at baseline and at 1 and 3 months post-training. Participants who are assigned to group 2 , will receive the TM training following the three month assessment, and then complete assessments at 1 and 3 months post-training.
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04586309
Sponsor's protocol ID
2008969193
Status last verified
Sep 2021
First submitted
2 Oct 2020
Last updated
1 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Lai J, Ma S, Wang Y, Cai Z, Hu J, Wei N, Wu J, Du H, Chen T, Li R, Tan H, Kang L, Yao L, Huang M, Wang H, Wang G, Liu Z, Hu S. Factors Associated With Mental Health Outcomes Among Health Care Workers Exposed to Coronavirus Disease 2019. JAMA Netw Open. 2020 Mar 2;3(3):e203976. doi: 10.1001/jamanetworkopen.2020.3976.

    PubMed 32202646
  • Valosek L, Link J, Mills P, Konrad A, Rainforth M, Nidich S. Effect of Meditation on Emotional Intelligence and Perceived Stress in the Workplace: A Randomized Controlled Study. Perm J. 2018;22:17-172. Published 2018 Oct 29. doi:10.7812/TPP/17-172

Questions about this trial

What is this clinical trial studying?

A study testing Transcendental meditation in people with Burnout, Professional and Stress, Psychological, run by University of Arizona.

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 6 inclusion and 3 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: withdrawn, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?

Burnout (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04586309, which also lists 2 linked publications.

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 1 Oct 2021; AzTrials last refreshed its copy on 8 Nov 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in