Ignite Creation Date:
2025-12-24 @ 7:38 PM
Ignite Modification Date:
2025-12-30 @ 9:27 PM
Study NCT ID:
NCT06977503
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-24
First Post:
2025-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electrotherapy Stimulation Together With Life Coaching for the Support of Burnout Symptoms in Healthcare Workers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006262', 'term': 'Health'}], 'ancestors': [{'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': "Researchers will be blinded with respect to subjects' study number, pre/post assessment data, and CES group (e.g., Group A versus Group B), the participants will remain blinded to which device they received (either sham or investigational device) throughout the duration of the study."}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-10-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-17', 'studyFirstSubmitDate': '2025-05-09', 'studyFirstSubmitQcDate': '2025-05-09', 'lastUpdatePostDateStruct': {'date': '2025-12-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptoms of burnout in healthcare workers (HCWs)', 'timeFrame': 'At baseline, 6 weeks, and 12 weeks', 'description': 'Will be assessed using the Mini-Z Survey. Will be summarized by study arm and time-point (baseline, midpoint, and follow-up) using the appropriate descriptive statistics, and graphically using mean or dot plots. The Mini-Z scores will be modeled as a function of study arm, time-point, their two-way interaction, and random cohort and subject (nested within cohort) effects using linear mixed models (LMMs).'}, {'measure': 'Symptoms of moral distress in HCWs', 'timeFrame': 'At baseline, 6 weeks, and 12 weeks', 'description': 'Will be assessed using the Measure of Moral Distress for Healthcare Workers (MMDHW). Will be summarized by study arm and time-point (baseline, midpoint, and follow-up) using the appropriate descriptive statistics, and graphically using mean or dot plots. The MMDHW scores will be modeled as a function of study arm, time-point, their two-way interaction, and random cohort and subject (nested within cohort) effects using LMMs.'}], 'secondaryOutcomes': [{'measure': 'Self-reported resilience in HCWs', 'timeFrame': 'At baseline, 6 weeks, and 12 weeks', 'description': 'Measure of resilience will be assessed using the Brief Resilient Coping Scale. Will be summarized by study arm and time-point (baseline and follow-up) using the appropriate descriptive statistics, and graphically using mean or dot plots. Will be modeled as a function of study arm, time-point, their two-way interaction, and random cohort and subject (nested within cohort) effects using LMMs.'}, {'measure': 'HCW self-reported probability of employment retention', 'timeFrame': 'At baseline, 6 weeks, and 12 weeks', 'description': 'Likelihood of employment retention will be assessed using the Organizational Wellbeing Assessment - Retention. Will be summarized by study arm and time-point (baseline and follow-up) using the appropriate descriptive statistics, and graphically using mean or dot plots. Will be modeled as a function of study arm, time-point, their two-way interaction, and random cohort and subject (nested within cohort) effects using LMMs.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psychiatric Disorder']}, 'descriptionModule': {'briefSummary': 'This clinical trial evaluates the effect of life coaching together with Cranial Electrotherapy Stimulation (CES) as an intervention to decrease self-reported symptoms of burnout, moral distress, resilience, and employee retention in oncology healthcare workers. Burnout and moral distress are occupational hazards for oncology healthcare workers. Emotional exhaustion, depersonalization, and lack of personal accomplishment at work are symptoms of burnout. Moral distress may be defined as knowing the right thing to do but being unable to do so based upon internal or external constraints. The device is attached to the earlobes that uses cranial electrotherapy stimulation (CES) at a microcurrent to alleviate symptoms of anxiety, insomnia, pain, and possibly depression. Life coaching is partnering with clients in a thought-provoking and creative process that inspires them to maximize their personal and professional potential and can increase resiliency skills such as boundary setting and prioritizing, increases in self-compassion and self-care, and potentially indirectly positively impact patient care. Undergoing the use of CES via the CES device, coupled with life coaching, may help alleviate burnout symptoms and moral distress in oncology healthcare workers.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To determine the efficacy of using Cranial Electrotherapy Stimulation (CES) with group life coaching sessions as an intervention to decrease healthcare worker self-reported symptoms of burnout and moral distress.\n\nSECONDARY OBJECTIVE:\n\nI. To determine the efficacy of using Cranial Electrotherapy Stimulation (CES) with group life coaching sessions as a supportive intervention to increase healthcare worker self-reported ratings of resilience, and employment retention (Organizational Wellbeing Assessment - Retention \\[OWA-R\\]).\n\nOUTLINE: Participants are randomized to 1 of 2 arms.\n\nARM I: During weeks 1-6, participants use the CES device once daily (QD) over 1 hour 5 days per week for 6 weeks on study. Participants also participate in virtual group life coaching sessions and discussions and view video assignments 3 times during weeks 1, 3, and 6. During weeks 7-12, participants cross-over and use the sham device QD over 1 hour 5 days per week for 6 weeks on study.\n\nARM II: During weeks 1-6, participants use the sham device QD over 1 hour 5 days per week for 6 weeks on study. Participants also participate in virtual group life coaching sessions and discussions and view video assignments 3 times during weeks 1, 3, and 6. During weeks 7-12, participants cross-over and use the CES device QD over 1 hour 5 days per week for 6 weeks on study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 21 ≤ and ≤ 75 years old\n* Patient-facing healthcare workers (e.g., medical doctor, advanced practice provider, nurse)\n* Experiencing symptoms of burnout, as defined by a score of 1, 2, or 3 on question #2 of the Mini-Z II Survey\n* Working on the Buffalo-Niagara Medical Campus (e.g. Roswell Park, Oishei Children's Hospital, Buffalo General, etc.)\n* Ability to attend three (3) in-person appointments, one (1) hour in duration, at Roswell Park at week 1, week 6 and week 12 corresponding to the initial, midpoint, and final assessments\n* Ability to use the CES daily for an hour each day\n\n * Although the device is water-resistant, participants must agree to not use the device in the bath or shower\n* Ability to read and write in English\n* Participant has access to a computer with internet access and an email address\n\n * Ability to attend three (3) virtual 60-minute group life coaching sessions, via Zoom\n * Ability to complete three (3) 10-15-minute pre-recorded video assignments, which will be distributed via email (each assignment will be due by the end of the week that they are distributed)\n* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure\n\nExclusion Criteria:\n\n* Subjects who self-report as pregnant or nursing. Pregnancy be verified with a urine test for all persons of childbearing potential with a uterus\n* Subjects with a self-reported history of the following: Meniere's disease, history of vertigo or prone to dizziness, seizure disorder, pacemaker / implantable cardioverter-defibrillator (automatic implantable cardioverter defibrillator \\[AICD\\]), cochlear implant, or any implanted electrical devices that cannot be shut off\n* Inability to tolerate the required minimum stimulation amplitude (200 uA) during the initial device training at the baseline visit.\n* Any self-reported medical or psychiatric condition which in the PI or study physician's opinion deems the participant an unsuitable candidate to participate in this trial.\n* Unwilling or unable to follow protocol requirements"}, 'identificationModule': {'nctId': 'NCT06977503', 'briefTitle': 'Electrotherapy Stimulation Together With Life Coaching for the Support of Burnout Symptoms in Healthcare Workers', 'organization': {'class': 'OTHER', 'fullName': 'Roswell Park Cancer Institute'}, 'officialTitle': 'A Pilot Study Using a Cranial Electrotherapy Stimulation (CES) Device in Conjunction With Life Coaching to Alleviate Burnout Symptoms in HealthCare Workers (HCWs)', 'orgStudyIdInfo': {'id': 'I-3956824'}, 'secondaryIdInfos': [{'id': 'NCI-2025-03017', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'I-3956824', 'type': 'OTHER', 'domain': 'Roswell Park Cancer Institute'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I (Cranial Electrotherapy Stimulation (CES) + life coaching)', 'description': 'During weeks 1-6, participants use the CES device QD over 1 hour 5 days per week for 6 weeks on study. Participants also participate in virtual group life coaching sessions and discussions and view video assignments 3 times during weeks 1, 3, and 6. During weeks 7-12, participants cross-over and use the sham device QD over 1 hour 5 days per week for 6 weeks on study.', 'interventionNames': ['Other: Discussion', 'Behavioral: Health and Wellness Coach', 'Other: Informational Intervention', 'Other: Survey Administration']}, {'type': 'SHAM_COMPARATOR', 'label': 'Arm II (Sham device + life coaching sessions)', 'description': 'During weeks 1-6, participants use the sham device QD over 1 hour 5 days per week for 6 weeks on study. Participants also participate in virtual group life coaching sessions and discussions and view video assignments 3 times during weeks 1, 3, and 6. During weeks 7-12, participants cross-over and use the CES device QD over 1 hour 5 days per week for 6 weeks on study.', 'interventionNames': ['Procedure: Cranial Electrical Stimulation (CES)', 'Other: Discussion', 'Behavioral: Health and Wellness Coach', 'Other: Informational Intervention', 'Procedure: Sham Intervention', 'Other: Survey Administration']}], 'interventions': [{'name': 'Cranial Electrical Stimulation (CES)', 'type': 'PROCEDURE', 'description': 'Use CES device', 'armGroupLabels': ['Arm II (Sham device + life coaching sessions)']}, {'name': 'Discussion', 'type': 'OTHER', 'otherNames': ['Discuss'], 'description': 'Participate in discussions', 'armGroupLabels': ['Arm I (Cranial Electrotherapy Stimulation (CES) + life coaching)', 'Arm II (Sham device + life coaching sessions)']}, {'name': 'Health and Wellness Coach', 'type': 'BEHAVIORAL', 'description': 'Undergo coaching sessions', 'armGroupLabels': ['Arm I (Cranial Electrotherapy Stimulation (CES) + life coaching)', 'Arm II (Sham device + life coaching sessions)']}, {'name': 'Informational Intervention', 'type': 'OTHER', 'description': 'View video assignments', 'armGroupLabels': ['Arm I (Cranial Electrotherapy Stimulation (CES) + life coaching)', 'Arm II (Sham device + life coaching sessions)']}, {'name': 'Sham Intervention', 'type': 'PROCEDURE', 'otherNames': ['Sham Comparator'], 'description': 'Undergo sham intervention', 'armGroupLabels': ['Arm II (Sham device + life coaching sessions)']}, {'name': 'Survey Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm I (Cranial Electrotherapy Stimulation (CES) + life coaching)', 'Arm II (Sham device + life coaching sessions)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'contacts': [{'name': 'Amy Gallagher, PsyD', 'role': 'CONTACT', 'email': 'Amy.Gallagher@roswellpark.org', 'phone': '716-845-7399'}, {'name': 'Amy Gallagher', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'overallOfficials': [{'name': 'Amy Gallagher, PsyD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Roswell Park Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Roswell Park Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}