Psychiatric Disorder
Conditions
Brief summary
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.
Detailed description
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. COHORT 1: ARM 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. ARM 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. COHORT 2: COHORT 2: ARM 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. ARM 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. COHORT 3: ARM 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. ARM 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. COHORT 4: ARM 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. ARM 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. After 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.
Interventions
Use CES device
Participate in discussions
Undergo coaching sessions
View video assignments
Undergo sham intervention
Sponsors
Study design
Masking description
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.
Eligibility
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 * 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/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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptoms of burnout in healthcare workers (HCWs) | At baseline, 8 weeks, and 15 weeks | 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). |
| Symptoms of moral distress in HCWs | At baseline, 8 weeks, and 15 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported resilience in HCWs | At baseline, 8 weeks, and 15 weeks | 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. |
| HCW self-reported probability of employment retention | At baseline, 8 weeks, and 15 weeks | 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. |
Countries
United States
Contacts
Roswell Park Cancer Institute