Clinical trial NCT05239429: 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
Overall status: COMPLETED
Phase: NA
Conditions: Burnout
Insomnia
Well Being
Keywords: Burnout
Well-being
Meditation
Insomnia
Lead sponsor: The Center for Clinical and Cosmetic Research
Sponsor class: OTHER
Collaborators: name: David Lynch Foundation
First posted: 2022-02-14
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Maslach Burnout Inventory- Human Services Survey (MBI-HSS) Score from Baseline
timeFrame: Baseline, 2 weeks, 1 month, and 3 months
measure: Change from Baseline in Insomnia Severity Index (ISI) Score
timeFrame: Baseline, 2 weeks, 1 month, and 3 months
measure: Change from Baseline in Brief Symptom Inventory 18 (BSI 18) Score
timeFrame: Baseline, 2 weeks, 1 month, and 3 months
measure: Change in Warwick-Edinburgh Mental Well Being Scale (WEMWBS) Score from Baseline
timeFrame: Baseline, 2 weeks, 1 month, and 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Aventura
country: United States
facility: The Center for Clinical and Cosmetic Research
state: Florida
Study officials:
affiliation: Center for Clinical and Cosmetic Research
name: Mark S Nestor, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: