An interventional study of Cranial Electrical Stimulation (CES) and Discussion in Psychiatric Disorder, sponsored by Roswell Park Cancer Institute. Recruiting at 1 site in United States. Open to participants aged 21 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-09.
Sponsored by Roswell Park Cancer Institute · Not applicable, Interventional, and Supportive care
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:
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.
1,740 studies on the registry are indexed under Mental Disorders; 348 are open to participants now.
This study's planned enrollment of 40 is below the median of 100 across 1,301 interventional studies indexed under Mental Disorders.
Browse Mental Disorders studies →Roswell Park Cancer Institute is the lead sponsor of 419 studies on the registry; 65 are open to participants now.
Of its 38 completed or terminated interventional studies of FDA-regulated products, 21 (55%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Ability to use the CES daily for an hour each day
Participant has access to a computer with internet access and an email address
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Devices received during week 1. During weeks 2-7, 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 during weeks 3, 5, and 7 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 cross-over and use the sham device QD over 1 hour 5 days per week for 6 weeks on study.
Procedure: Cranial Electrical Stimulation (CES) · Other: Discussion · Behavioral: Health and Wellness Coach
Devices received 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 during weeks 3, 5, and 7 and view video assignments 3 times during weeks 2, 4 and 6.. At week 8 participants cross over and exchange their device and receive their second device. During weeks 9-14, participants use the CES device QD over 1 hour 5 days per week for 6 weeks on study.
Other: Discussion · Behavioral: Health and Wellness Coach · Other: Informational Intervention · Procedure: Sham Intervention
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.
Procedure: Cranial Electrical Stimulation (CES) · Other: Discussion · Behavioral: Health and Wellness Coach · Other: Informational Intervention
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
Other: Discussion · Behavioral: Health and Wellness Coach · Other: Informational Intervention · Procedure: Sham Intervention
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
Procedure: Cranial Electrical Stimulation (CES) · Other: Discussion · Behavioral: Health and Wellness Coach
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.
Other: Discussion · Behavioral: Health and Wellness Coach · Procedure: Sham Intervention
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.
Procedure: Cranial Electrical Stimulation (CES) · Other: Discussion · Behavioral: Health and Wellness Coach
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.
Other: Discussion · Behavioral: Health and Wellness Coach · Procedure: Sham Intervention
Use CES device
Participate in discussions
Also known as: Discuss
Undergo coaching sessions
View video assignments
Undergo sham intervention
Also known as: Sham Comparator
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).
Time frame: At week 1, 8 weeks, and 15 weeks
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.
Time frame: At week 1, 8 weeks, and 15 weeks
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.
Time frame: At week 1, 8 weeks, and 15 weeks
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.
Time frame: At week 1, 8 weeks, and 15 weeks
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