Electrotherapy Stimulation Together With Life Coaching for the Support of Burnout Symptoms in Healthcare Workers

PRIMARY OBJECTIVE:

I. 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.

SECONDARY OBJECTIVE:

I. 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]).

OUTLINE: Participants are randomized to 1 of 2 arms.

ARM 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. At week 7, participants exchange device for second device. During weeks 8-13, participants cross-over and use the sham device QD over 1 hour 5 days per week for 6 weeks on study.

ARM 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. At week 7, participants exchange device for second device. During weeks 8-13, participants cross-over and use the CES device QD over 1 hour 5 days per week for 6 weeks on study.

Inclusion criteria

• 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
• Working on the Buffalo-Niagara Medical Campus (e.g. Roswell Park, Oishei Children's Hospital, Buffalo General, etc.)
• 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
• 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, 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/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion criteria

• 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 / 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