Data-driven Approaches to Healthcare Provider Resilience & Burnout During COVID-19

NCT04922632 | Terminated

• 1 other identifier: Pro00106079
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

Brief Summary

The United States is battling dual pandemics: healthcare provider (HCP) exhaustion and COVID-19. The COVID-19 pandemic death toll has surpassed 595,000 and continues to climb as the worldwide outbreak continues. Moreover, we have yet to understand the health impacts of "long-COVID". As evidenced by the national burnout epidemic in HCPs, persistent workplace stress not only impacts personal provider wellbeing, but also influences effective practice and patient outcomes. To address this need, we propose a 4-year, multi-site, four-arm parallel-group randomized clinical trial (RCT) comparing 2 non-pharmacological interventions: Transcendental Meditation (TM) and Experience Resolution Methodology (ERM) to Treatment as Usual (TAU). Participation in this study lasts up to 24 months for enrolled participants and is considered minimal risks.

Conditions

Burnout, Professional; Exhaustion, Caregiver; Covid19

Outcome Measures

Primary Outcomes (1)

• Change in resilience as measured by the Connor-Davidson Resilience Scale-25

  The Connor-Davidson Resilience scale (CD-RISC) comprises of 25 items, each rated on a 5-point scale (0-4), with higher scores reflecting greater resilience

  Baseline to 3 months

Secondary Outcomes (6)

• Change in burnout as measured by the Maslach Burnout Inventory (MBI).

  Baseline to 3 months

• Change in depression as measured by the Patient Health Questionnaire-9 (PHQ-9).

  Baseline to 3 months

• Change in psychological distress as measured by the Subject Units of Distress Scales (SUDS).

  Baseline to 3 months

• Change in quality of life as measured by the Quality of Life Enjoyment and Satisfaction Questionnaire - Short Form (Q-LES-Q-SF).

  Baseline to 3 months

• Change in PTSD symptom severity as measured by the Post-Traumatic Stress Disorder (PTSD) checklist-5 (PCL-5).

  Baseline to 3 months

Study Arms (4)

Transcendental Medication (TM)

EXPERIMENTAL

Transcendental Meditation (TM): a mind-body program that allows the participant to experience progressively quieter, less excited states of mental activity, with growing experience of restful alertness in mind and body.

Behavioral: Transcendental Meditation (TM)

Experience Resolution Methodology (ERM)

EXPERIMENTAL

Experience Resolution Methodology (ERM): is a specific, protocolized coaching method that aims to maximize an individual's performance, professional development and well-being by recognizing and resolving subjective stress associated with specific situations, circumstances, events or experiences.

Behavioral: Experience Resolution Methodology (ERM)

TM+ERM

EXPERIMENTAL

Transcendental Meditation (TM) and Experience Resolution Methodology (ERM): an integrative method using both TM and ERM coaching with ERM with the aim of achieving an overall restful, alertness in mind and body and maximizing performance, professional development and well-being.

Behavioral: Transcendental Meditation (TM) and Experience Resolution Methodology (ERM)

Treatment As Usual (TAU)

ACTIVE COMPARATOR

Treatment As Usual (TAU): is the existing Duke Health \& Well-being services, such as the availability of acupuncture, integrative health coaching, integrative nutrition and weight management, personal exercise training, massage therapy, yoga therapy, mindfulness-based stress reduction (MBSR), experiencing mindfulness, group fitness classes, gentle yoga, or chair yoga, as well as additional resources such as Personal Assistance Services (PAS).

Behavioral: Treatment As Usual (TAU)

Interventions

Transcendental Meditation (TM) BEHAVIORAL

TM is a mind-body program that allows the participant to experience progressively quieter, less excited states of mental activity, with growing experience of restful alertness in mind and body.

Transcendental Medication (TM)

Experience Resolution Methodology (ERM) BEHAVIORAL

ERM is a specific, protocolized coaching method that aims to maximize an individual's performance, professional development and well-being by recognizing and resolving subjective stress associated with specific situations, circumstances, events or experiences.

Experience Resolution Methodology (ERM)

Transcendental Meditation (TM) and Experience Resolution Methodology (ERM) BEHAVIORAL

TM + ERM is an integrative method using both TM and ERM coaching with ERM with the aim of achieving an overall restful, alertness in mind and body and maximizing performance, professional development and well-being.

TM+ERM

Treatment As Usual (TAU) BEHAVIORAL

TAU is the existing Duke Health \& Well-being services, such as the availability of acupuncture, integrative health coaching, integrative nutrition and weight management, personal exercise training, massage therapy, yoga therapy, mindfulness-based stress reduction (MBSR), experiencing mindfulness, group fitness classes, gentle yoga, or chair yoga, as well as additional resources such as Personal Assistance Services (PAS).

Treatment As Usual (TAU)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Full-time HCPs
• A score of \>= 5 on the Subjective Units of Distress Scale (SUDS) at baseline visit.
• Willingness to address burnout symptoms by non-pharmacological means.
• Willingness to wear the provided wearable device (e.g., Apple, Empatica, and/or eSense) at the designated study visits and/or determined coaching sessions, as well as wear an Apple device, if eligible to receive an Apple watch, from baseline for the duration of the study (up to 24 months).
• Willingness to download the PatternHealth app on personal device.

You may not qualify if:

• Addition or change in dosage of psychotropic medications, beta-blockers, or anti-epileptic medications within the last 2 months
• HCPs may re-present for screening again after 2 months has passed since their last change in the medication categories listed that previously excluded them for re-evaluation for study eligibility.
• Current suicidal or homicidal ideation at the time of screening, as defined by the C-SSRS.
• Prior instruction in the Transcendental Meditation (TM) technique by a certified instructor.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Burnout, Professional; Caregiver Burden; COVID-19

Interventions

Meditation; Therapeutics

Condition Hierarchy (Ancestors)

Occupational Stress; Occupational Diseases; Burnout, Psychological; Stress, Psychological; Behavioral Symptoms; Behavior; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Sangeeta Joshi, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: A 4-year, multi-site, four-arm parallel-group randomized clinical trial (RCT).

Study Record Dates

• First Submitted: June 8, 2021
• First Posted: June 10, 2021
• Study Start: February 21, 2022
• Primary Completion: March 12, 2023
• Study Completion: March 12, 2023
• Last Updated: April 21, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)