Burnout, ProfessionalNCT04632368
Targeting the Health Care Provider (HCP) Burnout Crisis During the COVID-19 Pandemic
A study testing Transcendental Meditation in people with Burnout, Professional and Stress, Psychological, run by Duke University at 1 site in United States.
Trial summary
This single blind, randomized, controlled trial (RCT) evaluates, a nonpharmacological intervention, TM (Transcendental Meditation) for improving burnout (, as measured by self-reporting (survey), physiologic, and neuro-functional imaging studies in health care providers (HCPs) when practiced over 3 months' time. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Burnout, Professional, Stress, Psychological
- What is being tested?
- Transcendental Meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2020to 16 Aug 2021
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- HCPs including physicians, trainee physicians, nurses, nurse practitioners, Physician Assistants, and respiratory therapists providing patient care during the COVID-19 pandemic.
- A single-item stress scale will be used as a screen for eligibility; a minimum score of 6 on a 10-point response scale will be needed to meet inclusion criteria
- Subjects who have at least a 5% increase from baseline in heart rate after exposure to a personalized stressful script OR at least a 33% increase in skin conductance after exposure to the script
- Willingness to address burnout symptoms by non-pharmacological means
- All subjects must provide Informed Consent prior to enrollment in the study.
- Willingness to wear the provided Apple Watch for the data collection process
Who cannot join
- Antipsychotic medications or beta-blockers
- Current suicidal or homicidal ideation (suicidal ideation as screened by C-SSRI survey pre-enrollment)
- Previous instruction in TM
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University health system
Durham, North Carolina, 27710
About this study
This single blind, randomized, controlled trial (RCT) evaluates, a nonpharmacological intervention, TM (Transcendental Meditation) for improving burnout (, as measured by self-reporting (survey), physiologic, and neuro-functional imaging studies in health care providers (HCPs) when practiced over 3 months' time. The investigators define HCPs as any physician, physician trainee, nurse, physician assistant, nurse practitioner or respiratory therapist.
HCPs will be screened by a single-item stress scale and Columbia Suicide Severity Rating Scale (CSSRS) to understand their stress level and exclusion criteria respectively. The Global Severity Index of the Brief Symptom Inventory (BSI)-18 Global Severity score will be used as the primary outcome for pre- and post-TM training (baseline, 1 vs. 3 months). In addition, the investigators will evaluate physiological markers of stress and cardiovascular resiliency such as 1) changes (pre/post-treatment) in heart rate variability (HRV) through wearables, 2) Galvanic Skin Response (GSR) - changes in sweat gland activity that result from changes in an emotional state. fMRI will be performed by the Duke Brain Imaging and Analysis Center (BIAC) on a subset of participants to evaluate changes A specifically developed mobile app will aid data collection as well as reminders for providers to aid compliance for meditation
Read the detailed description
OVERALL HYPOTHESIS: HCPs who learn and practice TM will demonstrate significantly improved symptoms of burnout within 3 months, as measured by self-report (survey), physiologic, and neuro-functional imaging studies.
SPECIFIC AIM 1: To conduct a single-blind, randomized, controlled trial (RCT) of TM (N=40) vs. Control (CTL, N=40) in frontline HCPs. HCPs will be screened by a single-item stress scale and Columbia Suicide Severity Rating Scale (CSSRS). The Global Severity Index of the Brief Symptom Inventory (BSI)-18 Global Severity score will be used as the primary outcome for pre- and post-TM training (baseline, 1 vs. 3 months). SPECIFIC AIM 2: Evaluate changes (pre/post-treatment) in heart rate variability (HRV), a physiological measure of stress, and overall cardiovascular resilience) in response to TM practice versus CTL. Participants will be asked to wear an Apple Watch throughout trial participation to assess changes in resting HRV during meditative practice. Galvanic Skin Response (GSR) refers to the changes in sweat gland activity that result from changes in an emotional state. A portable GSR device (e-Sense Skin Response) will be used to evaluate GSR score (baseline and 3 months). fMRI (N=20 for each group) will be performed by the Duke Brain Imaging and Analysis Center (BIAC).
fMRI Protocol: The first 20 eligible (exclusion criteria: pregnancy, claustrophobia, reluctance to participate) patients from each group will be randomly assigned to get fMRI at baseline and at the end of the study.
- Conditions
- Burnout, Professional, Stress, Psychological
- Being tested
- Transcendental Meditation
- Medical subject headings
- Burnout, Professional, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcendental MeditationBehavioural
TM, a mind-body intervention that can reduce sympathetic arousal and promote a state of relaxation and calm, will be offered to HCPs dealing with COVID-19 pandemic
| Study group | Role | What they receive |
|---|---|---|
| Transcendental Meditation Intervention Arm | Active comparator | TM, a mind-body intervention that can reduce sympathetic arousal and promote a state of relaxation and calm, will be offered to a randomized group of eligible HCPs ( N=40)providing care during COVID-19 pandemic. Receives: Behavioral: Transcendental Meditation |
| Treatment as usual(TAU) Control Arm | No intervention | Control group consists of eligible HCPs who are randomized to control group(N=40) and would not receive any intervention. At the end of 3 month study period, control group participants would be eligible for TM training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in self reported Stress symptoms
Changes in brief symptom inventory as evaluated by BSI 18
Measured: Baseline, 1 month, 3 months
Secondary outcomes (6)
Change in self reported resilience
These will include secondary outcomes as measured by the Connor Davidson Resilience Scale-25 (CD-RISC).
Measured: Baseline, 1 month, 3 months
Change in symptoms of depression
Change in symptoms of depression will be measured by PHQ 9 scale
Measured: Baseline, 1 month, 3 months
Change in insomnia symptoms
Change in insomnia symptoms as measured by Insomnia severity Index(ISI)
Measured: Baseline, 1 month, 3 months
Change in anxiety symptoms
Change in anxiety symptoms as measured by GAD-7
Measured: Baseline, 1 month, 3 months
Change in psychological distress
change in psychological distress as measured by the Global Severity Index of the Brief Symptom Inventory (BSI)-18 questionnaire.
Measured: Baseline, 1 month, 3 months
Change in self reported burnout symptoms
Change in burnout symptoms in HCPs as measured by Maslach Burnout Inventory( MBI)
Measured: Time Frame: Baseline, 1 month, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2020
- Study start20 Nov 2020
- Primary completion10 Aug 2021
- Study completion16 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible participants, on enrollment in the study, would be randomly assigned to meditation intervention group vs control group. Control group will be offered intervention at the end of the study
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04632368
- Sponsor's protocol ID
- Pro00106191
- Status last verified
- May 2021
- First submitted
- 11 Nov 2020
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Joshi SP, Wong AI, Brucker A, Ardito TA, Chow SC, Vaishnavi S, Lee PJ. Efficacy of Transcendental Meditation to Reduce Stress Among Health Care Workers: A Randomized Clinical Trial. JAMA Netw Open. 2022 Sep 1;5(9):e2231917. doi: 10.1001/jamanetworkopen.2022.31917.
PubMed 36121655
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting the Health Care Provider (HCP) Burnout Crisis During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04632368
- Acronym / sponsor ID
- Pro00106191
- Conditions
- Burnout, Professional, Stress, Psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 20 Nov 2020 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 16 Aug 2021 (actual)
- First posted
- 17 Nov 2020 (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.
This single blind, randomized, controlled trial (RCT) evaluates, a nonpharmacological intervention, TM (Transcendental Meditation) for improving burnout (, as measured by self-reporting (survey), physiologic, and neuro-functional imaging studies in health care providers (HCPs) when practiced over 3 months' time. The investigators define HCPs as any physician, physician trainee, nurse, physician assistant, nurse practitioner or respiratory therapist.
HCPs will be screened by a single-item stress scale and Columbia Suicide Severity Rating Scale (CSSRS) to understand their stress level and exclusion criteria respectively. The Global Severity Index of the Brief Symptom Inventory (BSI)-18 Global Severity score will be used as the primary outcome for pre- and post-TM training (baseline, 1 vs. 3 months). In addition, the investigators will evaluate physiological markers of stress and cardiovascular resiliency such as 1) changes (pre/post-treatment) in heart rate variability (HRV) through wearables, 2) Galvanic Skin Response (GSR) - changes in sweat gland activity that result from changes in an emotional state. fMRI will be performed by the Duke Brain Imaging and Analysis Center (BIAC) on a subset of participants to evaluate changes A specifically developed mobile app will aid data collection as well as reminders for providers to aid compliance for meditation
Detailed description
OVERALL HYPOTHESIS: HCPs who learn and practice TM will demonstrate significantly improved symptoms of burnout within 3 months, as measured by self-report (survey), physiologic, and neuro-functional imaging studies.
SPECIFIC AIM 1: To conduct a single-blind, randomized, controlled trial (RCT) of TM (N=40) vs. Control (CTL, N=40) in frontline HCPs. HCPs will be screened by a single-item stress scale and Columbia Suicide Severity Rating Scale (CSSRS). The Global Severity Index of the Brief Symptom Inventory (BSI)-18 Global Severity score will be used as the primary outcome for pre- and post-TM training (baseline, 1 vs. 3 months). SPECIFIC AIM 2: Evaluate changes (pre/post-treatment) in heart rate variability (HRV), a physiological measure of stress, and overall cardiovascular resilience) in response to TM practice versus CTL. Participants will be asked to wear an Apple Watch throughout trial participation to assess changes in resting HRV during meditative practice. Galvanic Skin Response (GSR) refers to the changes in sweat gland activity that result from changes in an emotional state. A portable GSR device (e-Sense Skin Response) will be used to evaluate GSR score (baseline and 3 months). fMRI (N=20 for each group) will be performed by the Duke Brain Imaging and Analysis Center (BIAC).
fMRI Protocol: The first 20 eligible (exclusion criteria: pregnancy, claustrophobia, reluctance to participate) patients from each group will be randomly assigned to get fMRI at baseline and at the end of the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Eligible participants, on enrollment in the study, would be randomly assigned to meditation intervention group vs control group. Control group will be offered intervention at the end of the study
| Arm | Type | Receives |
|---|---|---|
| Transcendental Meditation Intervention Arm | Active comparator | Behavioral: Transcendental MeditationTM, a mind-body intervention that can reduce sympathetic arousal and promote a state of relaxation and calm, will be offered to a randomized group of eligible HCPs ( N=40)providing care during COVID-19 pandemic. |
| Treatment as usual(TAU) Control Arm | No intervention | –Control group consists of eligible HCPs who are randomized to control group(N=40) and would not receive any intervention. At the end of 3 month study period, control group participants would be eligible for TM training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- HCPs including physicians, trainee physicians, nurses, nurse practitioners, Physician Assistants, and respiratory therapists providing patient care during the COVID-19 pandemic.
- A single-item stress scale will be used as a screen for eligibility; a minimum score of 6 on a 10-point response scale will be needed to meet inclusion criteria
- Subjects who have at least a 5% increase from baseline in heart rate after exposure to a personalized stressful script OR at least a 33% increase in skin conductance after exposure to the script
- Willingness to address burnout symptoms by non-pharmacological means
- All subjects must provide Informed Consent prior to enrollment in the study.
Key exclusion criteria (3 listed)
- Antipsychotic medications or beta-blockers
- Current suicidal or homicidal ideation (suicidal ideation as screened by C-SSRI survey pre-enrollment)
- Previous instruction in TM
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 MeditationTM, a mind-body intervention that can reduce sympathetic arousal and promote a state of relaxation and calm, will be offered to HCPs dealing with COVID-19 pandemic | Behavioural | Transcendental Meditation Intervention Arm |
Primary outcome
change in self reported Stress symptoms
Time frame: Baseline, 1 month, 3 months
Changes in brief symptom inventory as evaluated by BSI 18
6 secondary outcomes
Change in self reported resilience
Time frame: Baseline, 1 month, 3 months
Change in symptoms of depression
Time frame: Baseline, 1 month, 3 months
Change in insomnia symptoms
Time frame: Baseline, 1 month, 3 months
Change in anxiety symptoms
Time frame: Baseline, 1 month, 3 months
Change in psychological distress
Time frame: Baseline, 1 month, 3 months
Change in self reported burnout symptoms
Time frame: Time Frame: Baseline, 1 month, 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Derived from this study: PubMed 36121655Joshi SP, Wong AI, Brucker A, Ardito TA, Chow SC, Vaishnavi S, Lee PJ. Efficacy of Transcendental Meditation to Reduce Stress Among Health Care Workers: A Randomized Clinical Trial. JAMA Netw Open. 2022 Sep 1;5(9):e2231917. doi: 10.1001/jamanetworkopen.2022.31917.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 in people with Burnout, Professional and Stress, Psychological, 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 6 inclusion and 3 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: finished, as of the sponsor's last update on 23 Aug 2021. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 self reported Stress symptoms (time frame: Baseline, 1 month, 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04632368, which also lists 1 linked publication.
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 23 Aug 2021.