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

NCT04586309 | Withdrawn

• 1 other identifier: 2008969193
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Burnout, Professional; Stress, Psychological; Depression; Job Stress

Keywords

transcendental meditation; resilience; burnout

Outcome Measures

Primary Outcomes (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.

  baseline

• 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.

  1 month

• 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.

  3 month

Secondary Outcomes (18)

• Resilience

  baseline

• Resilience

  1 month

• Resilience

  3 months

• Alcohol use

  baseline

• Alcohol use

  1 month

Study Arms (2)

Early TM Training

EXPERIMENTAL

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

Delayed TM training

ACTIVE COMPARATOR

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

Interventions

Transcendental meditation BEHAVIORAL

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.

Delayed TM training; Early TM Training

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Full-time Resident physicians or Fellows employed by Banner Health
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arizona: lead
• David Lynch Foundation: collaborator

Related Publications (2)

• 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.

  PMID: 32202646 BACKGROUND

• 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

  BACKGROUND

Related Links

• Information from David Lynch Foundation regarding grant
• Information about transcendental meditation and other TM research

MeSH Terms

Conditions

Burnout, Professional; Stress, Psychological; Depression; Occupational Stress; Burnout, Psychological

Interventions

Meditation

Condition Hierarchy (Ancestors)

Occupational Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 2, 2020
• First Posted: October 14, 2020
• Study Start: June 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: December 1, 2021
• Last Updated: October 1, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share