Improving the Mental Health and Well Being of Healthcare Providers Through the Transcendental Meditation Technique

November 20, 2023 updated by: Mark Steven Nestor, M.D., Ph.D., The Center for Clinical and Cosmetic Research

Improving the Mental Health & Well-Being of Healthcare Providers During the COVID-19 Pandemic: A Parallel Population Study Investigating the Reduction of Burnout and Enhancement of Well-Being Through the Transcendental Meditation Technique

The level of stress-related disorders experienced by Healthcare Providers (HCPs) has increased due to the recent COVID-19 Pandemic, impacting patient care and provider shortages. This trial aims to evaluate the use of the Transcendental Meditation Technique in improving burnout and wellbeing of HCPs over a 3-month trial period.

A total of 130 HCPs will be recruited from participating Miami hospitals, with 65 HCPs receiving training in the use of the Transcendental Meditation Technique. The remaining participants will be part of a matched control group and will not receive any training. Study outcomes will be assessed at baseline, 2 weeks, 1 month, and 3 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This parallel population study aims to optimize and evaluate Healthcare Provider (HCP) wellness and performance through an evidence-based stress reduction program, Transcendental Meditation.

Transcendental Meditation (TM) has been found to be effective in reducing adverse mental health outcomes, including burnout, emotional exhaustion, depression, anxiety, insomnia, and trauma symptom severity. It is a mind-body program that allows the practitioner to experience progressively quieter, less excited states of mental activity.

For this trail, 65 HCPs affiliated with three participating Miami hospitals (Baptist Health South Florida Hospital, Mercy Miami Hospital and Encompass Health Rehabilitation Hospital of Miami) will receive instructions in the Transcendental Meditation Technique. A control group of similar numbers of HCPs will be recruited to match, to the best extent possible, for gender, age, type of HCP (doctor, nurse, etc.), and work schedule (e.g., days, nights, etc.). The control group participants will not receive Transcendental Meditation Technique training and will continue with their usual lifestyle.

The total duration of the study period will be 3 months. Study outcomes will be assessed at baseline, 2 weeks, 1 month, and 3 months' posttest, with change in burnout, insomnia, symptom, and well-being, as measured by the corresponding indexes as the primary outcomes.

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Aventura, Florida, United States, 33180
        • The Center for Clinical and Cosmetic Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Fulltime healthcare providers, medical doctors, physician assistants, nurses or other HCPs involved in active patient care or administration of patient care (Hospital Administration).
  2. 18 years or older.
  3. Have treated COVID-19 patients or working at locations where COVID-19 patients are being treated.
  4. Willing and able to complete both baseline and post-testing.
  5. If being treated with psychoactive medications, the maintenance of a stable regimen for at least two months before enrollment.
  6. In the non-control group, willing and able to dedicate the time to learning the Transcendental Meditation technique and practice it twice daily for approximately 20 minutes.

Exclusion Criteria:

  1. Already instructed in the Transcendental Meditation technique.
  2. Currently unstable psychiatric symptoms as demonstrated by self-report, medical chart, or psychiatric hospitalizations in the past six months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transcendental Meditation Technique
Participants are trained on the use of the Transcendental Meditation Technique. They will perform the technique twice a day for 20-minutes per session.
Behavioral: Transcendental Meditation Technique
Participants receive one-on-one training on how to use Transcendental Meditation technique which is then practiced twice daily for approximately 20 minutes.
No Intervention: Lifestyle-as-usual (control)
There is no change to the participants daily schedule and lifestyle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Maslach Burnout Inventory- Human Services Survey (MBI-HSS) Score from Baseline
Time Frame: Baseline, 2 weeks, 1 month, and 3 months

The Maslach Burnout Inventory- Human Services Survey (MBI-HSS) for Medical Personnel is used to measure participant burnout.

The scale is a 22-item inventory with a seven-point response scale of 0-6 (0=never; 6= Every day).
Baseline, 2 weeks, 1 month, and 3 months
Change from Baseline in Insomnia Severity Index (ISI) Score
Time Frame: Baseline, 2 weeks, 1 month, and 3 months

The Insomnia Severity Index (ISI) scale contains 7 sleep-related questions to measure severity of sleep problems.

A total score is calculated to interpret the participants level of insomnia, with a total score of 0-7 indicating no clinically significant insomnia and a score of 22-18 indicative of severe Clinical Insomnia.
Baseline, 2 weeks, 1 month, and 3 months
Change from Baseline in Brief Symptom Inventory 18 (BSI 18) Score
Time Frame: Baseline, 2 weeks, 1 month, and 3 months
The Brief Symptom Inventory 18 (BSI 18) is a 5-point rating scale used to gather patient-reported data to measure psychological distress and psychiatric disorders.
Baseline, 2 weeks, 1 month, and 3 months
Change in Warwick-Edinburgh Mental Well Being Scale (WEMWBS) Score from Baseline
Time Frame: Baseline, 2 weeks, 1 month, and 3 months
The Warwick-Edinburgh Mental Well Being Scale (WEMWBS) scale, covering both feeling and functioning aspects of mental wellbeing, contains 14 -items with 5 response categories, summed to provide a total score.
Baseline, 2 weeks, 1 month, and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Center for Clinical and Cosmetic Research

Collaborators

David Lynch Foundation

Investigators

  • Principal Investigator: Mark S Nestor, M.D., Ph.D., Center for Clinical and Cosmetic Research

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2020

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

February 2, 2022

First Submitted That Met QC Criteria

February 10, 2022

First Posted (Actual)

February 14, 2022

Study Record Updates

Last Update Posted (Estimated)

November 21, 2023

Last Update Submitted That Met QC Criteria

November 20, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCCR 01-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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