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

NCT05239429 | Completed

• 1 other identifier: CCCR 01-2020
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Burnout; Insomnia; Well Being

Keywords

Burnout; Well-being; Meditation; Insomnia

Outcome Measures

Primary Outcomes (4)

• 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).

  Baseline, 2 weeks, 1 month, and 3 months

• 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.

  Baseline, 2 weeks, 1 month, and 3 months

• 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.

  Baseline, 2 weeks, 1 month, and 3 months

• 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.

  Baseline, 2 weeks, 1 month, and 3 months

Study Arms (2)

Transcendental Meditation Technique

EXPERIMENTAL

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

Lifestyle-as-usual (control)

NO INTERVENTION

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

Interventions

Transcendental Meditation Technique BEHAVIORAL

Participants receive one-on-one training on how to use Transcendental Meditation technique which is then practiced twice daily for approximately 20 minutes.

Transcendental Meditation Technique

Eligibility Criteria

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

You may qualify if:

• Fulltime healthcare providers, medical doctors, physician assistants, nurses or other HCPs involved in active patient care or administration of patient care (Hospital Administration).
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Center for Clinical and Cosmetic Research: lead
• David Lynch Foundation: collaborator

Study Sites (1)

The Center for Clinical and Cosmetic Research

Aventura, Florida, 33180, United States

Location

Related Links

• David Lynch Foundation Website

MeSH Terms

Conditions

Burnout, Psychological; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Mark S Nestor, M.D., Ph.D.

  Center for Clinical and Cosmetic Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: February 2, 2022
• First Posted: February 14, 2022
• Study Start: June 30, 2020
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: November 21, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)