COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04586309
Recruitment Status : Not yet recruiting
First Posted : October 14, 2020
Last Update Posted : October 14, 2020
Sponsor:
Collaborators:
David Lynch Foundation
Tucson Transcendental Meditation Center
Information provided by (Responsible Party):
University of Arizona

Brief 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). 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).


Condition or disease Intervention/treatment Phase
Burnout, Professional Stress, Psychological Depression Job Stress Behavioral: Transcendental meditation Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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)
Primary Purpose: Supportive Care
Official Title: Improving the Mental Health of Resident Physicians and Fellows : Reducing Burnout & Enhancing Resilience Through Transcendental Meditation
Estimated Study Start Date : November 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Health

Arm Intervention/treatment
Experimental: Early TM Training
This group will receive training in Transcendental Meditation and will complete assessments at baseline, 1 month and 3 months.(3 assessments in total).
Behavioral: Transcendental meditation

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.

Active Comparator: Delayed TM training
This 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)
Behavioral: Transcendental meditation

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.




Primary Outcome Measures :
  1. Burnout [ Time Frame: baseline ]
    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.

  2. Burnout [ Time Frame: 1 month ]
    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.

  3. Burnout [ Time Frame: 3 month ]
    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.


Secondary Outcome Measures :
  1. Resilience [ Time Frame: baseline ]
    Connor-Davidson Resilience Scale- Participants respond to each prompt 0-5 x 25 items, low score indicates poor resilience.

  2. Resilience [ Time Frame: 1 month ]
    Connor-Davidson Resilience Scale- Participants respond to each prompt 0-5 x 25 items, low score indicates poor resilience.

  3. Resilience [ Time Frame: 3 months ]
    Connor-Davidson Resilience Scale- Participants respond to each prompt 0-5 x 25 items, low score indicates poor resilience.

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

  5. Alcohol use [ Time Frame: 1 month ]
    AUDIT: Alcohol Use Disorders Identification Test- Participants respond to 10 items with 0-4, higher score more concerning for alcohol use disorder.

  6. Alcohol use [ Time Frame: 3 months ]
    AUDIT: Alcohol Use Disorders Identification Test- Participants respond to 10 items with 0-4, higher score more concerning for alcohol use disorder.

  7. Depression [ Time Frame: baseline ]
    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.

  8. Depression [ Time Frame: 1 month ]
    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.

  9. Depression [ Time Frame: 3 months ]
    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.

  10. Sleep Quality [ Time Frame: baseline ]
    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.

  11. Sleep Quality [ Time Frame: 1 month ]
    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.

  12. Sleep Quality [ Time Frame: 3 months ]
    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.

  13. Distress [ Time Frame: baseline ]
    BSI18: Brief Symptom Inventory 18- Participants answer 18 questions on 0-4 scale. Higher numbers indicate more distress.

  14. Distress [ Time Frame: 1 month ]
    BSI18: Brief Symptom Inventory 18

  15. Distress [ Time Frame: 3 months ]
    BSI18: Brief Symptom Inventory 18

  16. Anxiety [ Time Frame: baseline ]
    GAD7: Generalized Anxiety Disorder 7- Participants answer 7 questions 0-3. Higher scores indicate greater anxiety,

  17. Anxiety [ Time Frame: 1 month ]
    GAD7: Generalized Anxiety Disorder 7- Participants answer 7 questions 0-3. Higher scores indicate greater anxiety,

  18. Anxiety [ Time Frame: 3 months ]
    GAD7: Generalized Anxiety Disorder 7- Participants answer 7 questions 0-3. Higher scores indicate greater anxiety,



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Full-time Resident physicians or Fellows employed by Banner Health
  2. 18 years or older
  3. Some participants included will have treated COVID-19 patients or be working at locations where COVID-19 patients are being treated.
  4. Willing to take part in either group assignment (randomized to either immediate start or TM training, or delayed TM training)
  5. Willing to complete baseline, 1-month and 3-month post- assessments
  6. If being treated with psychoactive medications, the maintenance of a stable regimen for at least two months before enrollment (by self-report).

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04586309


Contacts
Layout table for location contacts
Contact: Rachel E M Cramton, MD 14013459729 rcramton@peds.arizona.edu
Contact: Alison Sutton-Ryan, LCSW asuttonryan@email.arizona.edu

Sponsors and Collaborators
University of Arizona
David Lynch Foundation
Tucson Transcendental Meditation Center
Additional Information:
Publications:
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

Layout table for additonal information
Responsible Party: University of Arizona
ClinicalTrials.gov Identifier: NCT04586309    
Other Study ID Numbers: 2008969193
First Posted: October 14, 2020    Key Record Dates
Last Update Posted: October 14, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Arizona:
transcendental meditation
resilience
burnout
Additional relevant MeSH terms:
Layout table for MeSH terms
Occupational Stress
Burnout, Professional
Burnout, Psychological
Stress, Psychological
Behavioral Symptoms
Occupational Diseases