Burnout, ProfessionalNCT04922632
Data-driven Approaches to Healthcare Provider Resilience & Burnout During COVID-19
A study testing Transcendental Meditation (TM), Experience Resolution Methodology (ERM) and Transcendental Meditation (TM) and Experience Resolution Methodology (ERM) in people with Burnout, Professional and Exhaustion, Caregiver, run by Duke University at 1 site in United States.
Trial 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". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Burnout, Professional, Exhaustion, Caregiver, Covid19
- What is being tested?
- Transcendental Meditation (TM), Experience Resolution Methodology (ERM) and Transcendental Meditation (TM) and Experience Resolution Methodology (ERM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Feb 2022to 12 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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.
Read the detailed description
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". Taxed with an overloaded healthcare system, longer shifts, disrupted work-life balance, and the responsibility to uphold biosecurity with limited personal protective equipment (PPE), frontline HCPs are experiencing unprecedented levels of distress. A major and shared anxiety among HCPs is the fear of propagating the disease to their coworkers and their families. 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.
National institutes, such as the Joint Commission, are calling for the prioritization of healthcare workforce resilience in an effort to protect against rapid turnover, medical errors and suboptimal patient care. Resilience is defined as the "ability to respond to stress in a healthy, adaptive way, such that goals are met with minimal psychologic and physical cost". However, the major obstacle to systematically addressing HCPs burnout and building a resilience-based workforce is the sparsity of data on qualitative, physiologic, and biological predictors of resilience and evidence-based preventative, diagnostic, and treatment strategies. At this point, most health care institutions, if they are addressing burnout and resilience at all, offer a form of executive coaching. However, there is limited systematic evidence to support benefit.
To address this need, we propose a 4-year, multi-site, four-arm parallel-group randomized clinical trial (RCT) that will be operationalized via three distinct aims:
- Aim 1: To assess the efficacy of 1) Transcendental Meditation® (TM®) versus Treatment as Usual (TAU), 2) a form of coaching termed Experience Resolution Methodology (ERM) versus TAU, and 3) TM plus ERM versus TAU in increasing resilience and reducing burnout syndrome in HCPs.
- Aim 2: To characterize the biometric, immunologic, and neuro-functional characteristics of HCPs' resilience and burnout.
- Aim 3: To develop a medical predictive model and a composite resilience and burnout index.
For this study, the term "health care provider" (HCP) will be all inclusive of any individual working in a health care setting with patient-facing responsibilities in addition to physician and physician trainees.
- Conditions
- Burnout, Professional, Exhaustion, Caregiver, Covid19
- Being tested
- Transcendental Meditation (TM), Experience Resolution Methodology (ERM), Transcendental Meditation (TM) and Experience Resolution Methodology (ERM), Treatment As Usual (TAU)
- Medical subject headings
- Burnout, Professional, Caregiver Burden, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcendental Meditation (TM)Behavioural
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.
Experience Resolution Methodology (ERM)Behavioural
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.
Transcendental Meditation (TM) and Experience Resolution Methodology (ERM)Behavioural
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.
Treatment As Usual (TAU)Behavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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). Receives: Behavioral: Treatment As Usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline to 3 months
Secondary outcomes (6)
Change in burnout as measured by the Maslach Burnout Inventory (MBI).
The MBI consists of 3 scales to assess emotional exhaustion, depersonalization, and personal accomplishment with higher scores reflecting greater burnout. The MBI is composed of 22 items, each rated on a scale of 0 to 6, 0 being equivalent to "never" and 6 being equivalent to "every day." The lower scores reflect greater burnout.
Measured: Baseline to 3 months
Change in depression as measured by the Patient Health Questionnaire-9 (PHQ-9).
The PHQ-9 is a 9 question survey that rates responses on a scale of 0 to 3, 0 being equivalent to "not at all" and 3 equivalent to "nearly every day". The higher scores reflect greater depression in an individual.
Measured: Baseline to 3 months
Change in psychological distress as measured by the Subject Units of Distress Scales (SUDS).
The Subjective Units of Distress Scale (SUDS) is a 0 to 10 scale, 0 being "totally relaxed" and 10 being "highest/distress/fear/anxiety/discomfort that you have ever felt". The SUDS measures subjective intensity of disturbance or distress. The higher the score the great the individual's psychological distress.
Measured: 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).
The Q-LES-Q-SF is an assessment that measures the degree of enjoyment and satisfaction experienced by individuals in various areas of daily functioning. It is a 16 item assessment on a scale of 1 to 5, 1 being equivalent to "very poor" and 5 being equivalent to "very good." The higher scores reflect increased perceived quality of life.
Measured: Baseline to 3 months
Change in PTSD symptom severity as measured by the Post-Traumatic Stress Disorder (PTSD) checklist-5 (PCL-5).
The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD rated on a scale of 0 to 4, 0 being "not at all" and 4 "extremely." The higher scores reflect greater PTSD.
Measured: Baseline to 3 months
Change in sleep as measured by the Insomnia Severity Index (ISI).
The ISI is a patient-reported outcome that assesses the individual's sleep patterns over the past 2 weeks. The ISI is a 7 item questionnaire on a scale of 0 to 4, 0 being "none" and 4 being "very severe". The higher score indicates worse sleep quality.
Measured: Baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start21 Feb 2022
- Primary completion12 Mar 2023
- Study completion12 Mar 2023
Why it stopped: Funding was exhausted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Burnout, ProfessionalStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A 4-year, multi-site, four-arm parallel-group randomized clinical trial (RCT).
- Masking
- None (open label)
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sangeeta Joshi, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922632
- Sponsor's protocol ID
- Pro00106079
- Status last verified
- Apr 2023
- First submitted
- 8 Jun 2021
- Last updated
- 21 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified data, post analysis may be shared with other researchers at scientific meetings and published within scientific journals.
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data-driven Approaches to Healthcare Provider Resilience & Burnout During COVID-19
- ClinicalTrials.gov ID
- NCT04922632
- Acronym / sponsor ID
- Pro00106079
- Conditions
- Burnout, Professional, Exhaustion, Caregiver, Covid19
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding was exhausted
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 12 Mar 2023 (actual)
- Study completion
- 12 Mar 2023 (actual)
- First posted
- 10 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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". Taxed with an overloaded healthcare system, longer shifts, disrupted work-life balance, and the responsibility to uphold biosecurity with limited personal protective equipment (PPE), frontline HCPs are experiencing unprecedented levels of distress. A major and shared anxiety among HCPs is the fear of propagating the disease to their coworkers and their families. 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.
National institutes, such as the Joint Commission, are calling for the prioritization of healthcare workforce resilience in an effort to protect against rapid turnover, medical errors and suboptimal patient care. Resilience is defined as the "ability to respond to stress in a healthy, adaptive way, such that goals are met with minimal psychologic and physical cost". However, the major obstacle to systematically addressing HCPs burnout and building a resilience-based workforce is the sparsity of data on qualitative, physiologic, and biological predictors of resilience and evidence-based preventative, diagnostic, and treatment strategies. At this point, most health care institutions, if they are addressing burnout and resilience at all, offer a form of executive coaching. However, there is limited systematic evidence to support benefit.
To address this need, we propose a 4-year, multi-site, four-arm parallel-group randomized clinical trial (RCT) that will be operationalized via three distinct aims:
- Aim 1: To assess the efficacy of 1) Transcendental Meditation® (TM®) versus Treatment as Usual (TAU), 2) a form of coaching termed Experience Resolution Methodology (ERM) versus TAU, and 3) TM plus ERM versus TAU in increasing resilience and reducing burnout syndrome in HCPs.
- Aim 2: To characterize the biometric, immunologic, and neuro-functional characteristics of HCPs' resilience and burnout.
- Aim 3: To develop a medical predictive model and a composite resilience and burnout index.
For this study, the term "health care provider" (HCP) will be all inclusive of any individual working in a health care setting with patient-facing responsibilities in addition to physician and physician trainees.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- A 4-year, multi-site, four-arm parallel-group randomized clinical trial (RCT).
| Arm | Type | Receives |
|---|---|---|
| Transcendental Medication (TM) | Experimental | Behavioral: Transcendental Meditation (TM)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. |
| Experience Resolution Methodology (ERM) | Experimental | Behavioral: Experience Resolution Methodology (ERM)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. |
| TM+ERM | Experimental | Behavioral: Transcendental Meditation (TM) and Experience Resolution Methodology (ERM)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. |
| Treatment As Usual (TAU) | Active comparator | Behavioral: Treatment As Usual (TAU)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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcendental Meditation (TM)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. | Behavioural | Transcendental Medication (TM) |
| Experience Resolution Methodology (ERM)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. | Behavioural | Experience Resolution Methodology (ERM) |
| Transcendental Meditation (TM) and Experience Resolution Methodology (ERM)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. | Behavioural | TM+ERM |
| Treatment As Usual (TAU)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). | Behavioural | Treatment As Usual (TAU) |
Primary outcome
Change in resilience as measured by the Connor-Davidson Resilience Scale-25
Time frame: Baseline to 3 months
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
6 secondary outcomes
Change in burnout as measured by the Maslach Burnout Inventory (MBI).
Time frame: Baseline to 3 months
Change in depression as measured by the Patient Health Questionnaire-9 (PHQ-9).
Time frame: Baseline to 3 months
Change in psychological distress as measured by the Subject Units of Distress Scales (SUDS).
Time frame: 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).
Time frame: Baseline to 3 months
Change in PTSD symptom severity as measured by the Post-Traumatic Stress Disorder (PTSD) checklist-5 (PCL-5).
Time frame: Baseline to 3 months
Change in sleep as measured by the Insomnia Severity Index (ISI).
Time frame: Baseline to 3 months
Results and safety
The study was stopped early (reason given: Funding was exhausted). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2023.
- Individual participant dataSharing planned: No. De-identified data, post analysis may be shared with other researchers at scientific meetings and published within scientific journals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sangeeta Joshi, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcendental Meditation (TM), Experience Resolution Methodology (ERM) and Transcendental Meditation (TM) and Experience Resolution Methodology (ERM) in people with Burnout, Professional and Exhaustion, Caregiver, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding was exhausted). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in resilience as measured by the Connor-Davidson Resilience Scale-25 (time frame: Baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2023.