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

Primary Purpose

Burnout, Insomnia, Well Being

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcendental Meditation Technique
Sponsored by
The Center for Clinical and Cosmetic Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Burnout focused on measuring Burnout, Well-being, Meditation, Insomnia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • The Center for Clinical and Cosmetic Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Transcendental Meditation Technique

Lifestyle-as-usual (control)

Arm Description

Participants are trained on the use of the Transcendental Meditation Technique. They will perform the technique twice a day for 20-minutes per session.

There is no change to the participants daily schedule and lifestyle.

Outcomes

Primary Outcome Measures

Change in Maslach Burnout Inventory- Human Services Survey (MBI-HSS) Score from Baseline
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).
Change from Baseline in Insomnia Severity Index (ISI) Score
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.
Change from Baseline in Brief Symptom Inventory 18 (BSI 18) Score
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.
Change in Warwick-Edinburgh Mental Well Being Scale (WEMWBS) Score from Baseline
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.

Secondary Outcome Measures

Full Information

First Posted
February 2, 2022
Last Updated
February 14, 2022
Sponsor
The Center for Clinical and Cosmetic Research
Collaborators
David Lynch Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05239429
Brief Title
Improving the Mental Health and Well Being of Healthcare Providers Through the Transcendental Meditation Technique
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 30, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Center for Clinical and Cosmetic Research
Collaborators
David Lynch Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burnout, Insomnia, Well Being
Keywords
Burnout, Well-being, Meditation, Insomnia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
130 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transcendental Meditation Technique
Arm Type
Experimental
Arm Description
Participants are trained on the use of the Transcendental Meditation Technique. They will perform the technique twice a day for 20-minutes per session.
Arm Title
Lifestyle-as-usual (control)
Arm Type
No Intervention
Arm Description
There is no change to the participants daily schedule and lifestyle.
Intervention Type
Behavioral
Intervention Name(s)
Transcendental Meditation Technique
Intervention Description
Participants receive one-on-one training on how to use Transcendental Meditation technique which is then practiced twice daily for approximately 20 minutes.
Primary Outcome Measure Information:
Title
Change in Maslach Burnout Inventory- Human Services Survey (MBI-HSS) Score from Baseline
Description
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).
Time Frame
Baseline, 2 weeks, 1 month, and 3 months
Title
Change from Baseline in Insomnia Severity Index (ISI) Score
Description
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.
Time Frame
Baseline, 2 weeks, 1 month, and 3 months
Title
Change from Baseline in Brief Symptom Inventory 18 (BSI 18) Score
Description
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.
Time Frame
Baseline, 2 weeks, 1 month, and 3 months
Title
Change in Warwick-Edinburgh Mental Well Being Scale (WEMWBS) Score from Baseline
Description
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.
Time Frame
Baseline, 2 weeks, 1 month, and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Fulltime healthcare providers, medical doctors, physician assistants, nurses or other HCPs involved in active patient care or administration of patient care (Hospital Administration). 18 years or older. Have treated COVID-19 patients or working at locations where COVID-19 patients are being treated. Willing and able to complete both baseline and post-testing. If being treated with psychoactive medications, the maintenance of a stable regimen for at least two months before enrollment. 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: Already instructed in the Transcendental Meditation technique. Currently unstable psychiatric symptoms as demonstrated by self-report, medical chart, or psychiatric hospitalizations in the past six months.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark S Nestor, M.D., Ph.D.
Organizational Affiliation
Center for Clinical and Cosmetic Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Center for Clinical and Cosmetic Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.davidlynchfoundation.org/
Description
David Lynch Foundation Website

Learn more about this trial

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

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