[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06977503":3,"trial-entities:NCT06977503":128,"trial-summary:NCT06977503":132},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":63,"secondary_outcomes":71,"sex":78,"minimum_age":79,"maximum_age":80,"healthy_volunteers":81,"eligibility_criteria":82,"std_ages":102,"locations":105,"central_contacts":123,"overall_officials":124,"references":126,"see_also_links":127},"NCT06977503","I-3956824","Electrotherapy Stimulation Together With Life Coaching for the Support of Burnout Symptoms in Healthcare Workers","A Pilot Study Using a Cranial Electrotherapy Stimulation (CES) Device in Conjunction With Life Coaching to Alleviate Burnout Symptoms in HealthCare Workers (HCWs)","RECRUITING","2027-10-04","2026-09","2026-09-09","2026-02-04","Roswell Park Cancer Institute","OTHER",false,"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.","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\nCOHORT 1:\n\nARM I:Participants receive their devices during week 1. During weeks 2-7, 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 2, 4, and 6. Participants cross-over and exchange their device at week 8.. During weeks 9-14, participants use the sham device QD over 1 hour 5 days per week for 6 weeks on study.\n\nARM II: Participants receive their devices during week 1. During weeks 2-,7 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 during weeks 3, 5, and 7. At week 8, participants exchange device for second device. During weeks 9-14, participants use the CES device QD over 1 hour 5 days per week for 6 weeks on study.\n\nCOHORT 2:\n\nCOHORT 2:\n\nARM III: Participants receive their devices during week 9. During weeks 10-15, participants use the CES device QD over 1 hour 5 days per week for 6 weeks on study. Participants also attend virtual group life coaching sessions and discussions during weeks 11, 13, and 15 and view video assignments 3 times during weeks 10, 12, and 14. Participants cross-over and exchange their devices at week 16. During weeks 7-22, participants use the sham device QD over 1 hour 5 days per week for 6 weeks on study.\n\nARM IV: Participants receive their devices during week 9. During weeks 10-15, participants use the sham device QD over 1 hour 5 days per week for 6 weeks on study. Participants also attend virtual group life coaching sessions and discussions during weeks 11, 13, and 15 and view video assignments 3 times during weeks 10, 12, and 14. Participants cross-over and exchange their devices at week 16. During weeks 7-22, participants use the CES device QD over 1 hour 5 days per week for 6 weeks on study.\n\nCOHORT 3:\n\nARM V: Participants receive their devices during week 17. During weeks 18-23, participants use the CES device QD over 1 hour 5 days per week for 6 weeks on study. Participants also attend virtual group life coaching sessions and discussions during weeks 19, 21, and 23 and view video assignments 3 times during weeks 18, 20, and 22. Participants cross-over and exchange their devices at week 24. During weeks 25-30, participants use the sham device QD over 1 hour 5 days per week for 6 weeks on study.\n\nARM VI: Participants receive their devices during week 17. During weeks 18-23, participants use the sham device QD over 1 hour 5 days per week for 6 weeks on study. Participants also attend virtual group life coaching sessions and discussions during weeks 19, 21, and 23 and view video assignments 3 times during weeks 18, 20, and 22. Participants cross-over and exchange their devices at week 24. During weeks 25-30, participants use the CES device QD over 1 hour 5 days per week for 6 weeks on study.\n\nCOHORT 4:\n\nARM VII: Participants receive their devices during week 25. During weeks 26-31, participants use the CES device QD over 1 hour 5 days per week for 6 weeks on study. Participants also attend virtual group life coaching sessions and discussions during weeks 27, 29, and 31 and view video assignments 3 times during weeks 26, 28, and 30. Participants cross-over and exchange their devices at week 32. During weeks 33-38, participants use the sham device QD over 1 hour 5 days per week for 6 weeks on study.\n\nARM VIII: Participants receive their devices during week 25. During weeks 26-31, participants use the sham device QD over 1 hour 5 days per week for 6 weeks on study. Participants also attend virtual group life coaching sessions and discussions during weeks 27, 29, 31 and view video assignments 3 times during weeks 26, 28, 30. Participants cross-over and exchange their devices at week 32. During weeks 33-38, participants use the CES device QD over 1 hour 5 days per week for 6 weeks on study.\n\nAfter completion of study intervention, participants are followed up at week 15 for cohort 1, week 23 for cohort 2, week 31 for cohort 3, and week 39 for cohort 4.",[19],"Psychiatric Disorder",[],"INTERVENTIONAL","SUPPORTIVE_CARE",[24],"NA",{"count":26,"type":27},40,"ESTIMATED",[29,38,48,53,57],{"type":30,"name":31,"description":32,"armGroupLabels":33},"PROCEDURE","Cranial Electrical Stimulation (CES)","Use CES device",[34,35,36,37],"Cohort 1- Arm 1 (Cranial Electrotherapy Stimulation (CES) + life coaching)","Cohort 2 - Arm III - CES device + life coaching sessions","Cohort 3, Arm V (CES device + life coaching sessions)","Cohort 4, Arm VII (CES device + life coaching sessions)",{"type":14,"name":39,"description":40,"armGroupLabels":41,"otherNames":46},"Discussion","Participate in discussions",[42,34,35,43,36,44,37,45],"Cohort 1 -Arm II (Sham device + life coaching sessions)","Cohort 2 - Arm IV (Sham device + life coaching sessions","Cohort 3, Arm VI (Sham-device + life coaching sessions)","Cohort 4, Arm VIII (Sham device + life coaching sessions)",[47],"Discuss",{"type":49,"name":50,"description":51,"armGroupLabels":52},"BEHAVIORAL","Health and Wellness Coach","Undergo coaching sessions",[42,34,35,43,36,44,37,45],{"type":14,"name":54,"description":55,"armGroupLabels":56},"Informational Intervention","View video assignments",[42,35,43],{"type":30,"name":58,"description":59,"armGroupLabels":60,"otherNames":61},"Sham Intervention","Undergo sham intervention",[42,43,44,45],[62],"Sham Comparator",[64,68],{"measure":65,"description":66,"timeFrame":67},"Symptoms of burnout in healthcare workers (HCWs)","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).","At baseline, 8 weeks, and 15 weeks",{"measure":69,"description":70,"timeFrame":67},"Symptoms of moral distress in HCWs","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.",[72,75],{"measure":73,"description":74,"timeFrame":67},"Self-reported resilience in HCWs","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":76,"description":77,"timeFrame":67},"HCW self-reported probability of employment retention","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.","ALL","21 Years","75 Years",true,{"inclusion":83,"exclusion":95,"raw_text":101},[84,85,86,87,88,89,90,91,92,93,94],"Age 21 ≤ and ≤ 75 years old","Patient-facing healthcare workers (e.g., medical doctor, advanced practice provider, nurse)","Experiencing symptoms of burnout, as defined by a score of 1, 2, or 3 on question #2 of the Mini-Z II Survey","Ability to attend three (3) in-person appointments, one (1) hour in duration, at Roswell Park at week 1, week 6 and week 15 corresponding to the initial, midpoint, and final assessments","Ability to use the CES daily for an hour each day","Although the device is water-resistant, participants must agree to not use the device in the bath or shower","Ability to read and write in English","Participant has access to a computer with internet access and an email address","Ability to attend three (3) virtual 60-minute group life coaching sessions occuring Mondays at 6:30pm EST, via Zoom","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)","Participant must understand the investigational nature of this study and sign an Independent Ethics Committee\u002FInstitutional Review Board approved written informed consent form prior to receiving any study related procedure",[96,97,98,99,100],"Subjects who self-report as pregnant or nursing. Pregnancy be verified with a urine test for all persons of childbearing potential with a uterus","Subjects with a self-reported history of the following: Meniere's disease, history of vertigo or prone to dizziness, seizure disorder, pacemaker \u002F implantable cardioverter-defibrillator (automatic implantable cardioverter defibrillator \\[AICD\\]), cochlear implant, or any implanted electrical devices that cannot be shut off","Inability to tolerate the required minimum stimulation amplitude (200 uA) during the initial device training at the baseline visit.","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.","Unwilling or unable to follow protocol requirements","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* Ability to attend three (3) in-person appointments, one (1) hour in duration, at Roswell Park at week 1, week 6 and week 15 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 occuring Mondays at 6:30pm EST, 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\u002FInstitutional 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 \u002F 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",[103,104],"ADULT","OLDER_ADULT",[106],{"facility":13,"status":8,"city":107,"state":108,"zip":109,"country":110,"contacts":111,"geoPoint":120},"Buffalo","New York","14263","United States",[112,117],{"name":113,"role":114,"phone":115,"email":116},"Amy Gallagher, PsyD","CONTACT","716-845-7399","Amy.Gallagher@roswellpark.org",{"name":118,"role":119},"Amy Gallagher","PRINCIPAL_INVESTIGATOR",{"lat":121,"lon":122},42.88645,-78.87837,[],[125],{"name":113,"affiliation":13,"role":119},[],[],{"nct_id":4,"conditions":129,"biomarkers":131},[130],"Physical AND emotional exhaustion state",[],{"nct_id":4,"found":81,"summary":133,"prompt_version":143},{"design":134,"status":135,"heading":136,"summary":137,"follow_up":138,"word_count":139,"commitments":140,"compensation":141,"drugs_mentioned":142},"This interventional study plans to enroll 40 participants who will be randomly assigned to one of two groups. One group will receive CES and coaching first, then a sham (inactive) device and coaching, while the other group will do the reverse.","completed","Electrotherapy and Coaching for Burnout in Healthcare Workers","This study is looking at whether Cranial Electrotherapy Stimulation (CES) combined with life coaching can help reduce burnout and moral distress in healthcare workers. CES involves a device attached to your earlobes that uses a small electrical current to help with anxiety, insomnia, and pain. The study aims to see if this combination can also improve resilience and help healthcare workers stay in their jobs. You might be able to join if you are a patient-facing healthcare worker between 21 and 75 years old, work on the Buffalo-Niagara Medical Campus, and are experiencing symptoms of burnout. The study will measure burnout and moral distress at the start, after 6 weeks, and after 13 weeks.","Your symptoms of burnout and moral distress will be measured at baseline, 6 weeks, and 13 weeks.",114,"Participants will use a device for 1 hour daily, 5 days a week for 6 weeks, and then switch devices for another 6 weeks. You will also participate in virtual group life coaching sessions and discussions, and view video assignments three times during weeks 1, 3, and 6.","Not stated in the trial record.",[],"v2"]