Ignite Creation Date:
2025-12-24 @ 5:39 PM
Ignite Modification Date:
2026-01-06 @ 10:18 AM
Study NCT ID:
NCT04632368
Status:
COMPLETED
Last Update Posted:
2021-08-23
First Post:
2020-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Targeting the Health Care Provider (HCP) Burnout Crisis During the COVID-19 Pandemic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002055', 'term': 'Burnout, Professional'}, {'id': 'D013315', 'term': 'Stress, Psychological'}], 'ancestors': [{'id': 'D000073397', 'term': 'Occupational Stress'}, {'id': 'D009784', 'term': 'Occupational Diseases'}, {'id': 'D000077062', 'term': 'Burnout, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019122', 'term': 'Meditation'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D012064', 'term': 'Relaxation Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2021-08-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-19', 'studyFirstSubmitDate': '2020-11-11', 'studyFirstSubmitQcDate': '2020-11-16', 'lastUpdatePostDateStruct': {'date': '2021-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in self reported Stress symptoms', 'timeFrame': 'Baseline, 1 month, 3 months', 'description': 'Changes in brief symptom inventory as evaluated by BSI 18'}], 'secondaryOutcomes': [{'measure': 'Change in self reported resilience', 'timeFrame': 'Baseline, 1 month, 3 months', 'description': 'These will include secondary outcomes as measured by the Connor Davidson Resilience Scale-25 (CD-RISC).'}, {'measure': 'Change in symptoms of depression', 'timeFrame': 'Baseline, 1 month, 3 months', 'description': 'Change in symptoms of depression will be measured by PHQ 9 scale'}, {'measure': 'Change in insomnia symptoms', 'timeFrame': 'Baseline, 1 month, 3 months', 'description': 'Change in insomnia symptoms as measured by Insomnia severity Index(ISI)'}, {'measure': 'Change in anxiety symptoms', 'timeFrame': 'Baseline, 1 month, 3 months', 'description': 'Change in anxiety symptoms as measured by GAD-7'}, {'measure': 'Change in psychological distress', 'timeFrame': 'Baseline, 1 month, 3 months', 'description': 'change in psychological distress as measured by the Global Severity Index of the Brief Symptom Inventory (BSI)-18 questionnaire.'}, {'measure': 'Change in self reported burnout symptoms', 'timeFrame': 'Time Frame: Baseline, 1 month, 3 months', 'description': 'Change in burnout symptoms in HCPs as measured by Maslach Burnout Inventory( MBI)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Burnout, Professional', 'Stress, Psychological']}, 'referencesModule': {'references': [{'pmid': '36121655', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': "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.\n\nHCPs 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", 'detailedDescription': '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.\n\nSPECIFIC 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).\n\nfMRI 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nHCPs including physicians, trainee physicians, nurses, nurse practitioners, Physician Assistants, and respiratory therapists providing patient care during the COVID-19 pandemic.\n\n* 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\n* 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\n* Willingness to address burnout symptoms by non-pharmacological means\n* All subjects must provide Informed Consent prior to enrollment in the study.\n* Willingness to wear the provided Apple Watch for the data collection process\n\nExclusion Criteria:\n\n* Antipsychotic medications or beta-blockers\n* Current suicidal or homicidal ideation (suicidal ideation as screened by C-SSRI survey pre-enrollment)\n* Previous instruction in TM'}, 'identificationModule': {'nctId': 'NCT04632368', 'briefTitle': 'Targeting the Health Care Provider (HCP) Burnout Crisis During the COVID-19 Pandemic', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Targeting the Health Care Provider (HCP) Burnout Crisis During the COVID-19 Pandemic', 'orgStudyIdInfo': {'id': 'Pro00106191'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Transcendental Meditation Intervention Arm', 'description': '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.', 'interventionNames': ['Behavioral: Transcendental Meditation']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment as usual(TAU) Control Arm', 'description': '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.'}], 'interventions': [{'name': 'Transcendental Meditation', 'type': 'BEHAVIORAL', 'description': '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', 'armGroupLabels': ['Transcendental Meditation Intervention Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University health system', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}