Psychiatric DisorderNCT06977503
Electrotherapy Stimulation Together With Life Coaching for the Support of Burnout Symptoms in Healthcare Workers
A study testing Cranial Electrical Stimulation (CES), Discussion and Health and Wellness Coach in people with Psychiatric Disorder, run by Roswell Park Cancer Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Psychiatric Disorder
- What is being tested?
- Cranial Electrical Stimulation (CES), Discussion and Health and Wellness Coach
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2026to 4 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Roswell Park Cancer Institute
Buffalo, New York, 14263
Amy Gallagher, PsyD, 716-845-7399, Amy.Gallagher@roswellpark.org
Amy Gallagher
About this study
Official title: A Pilot Study Using a Cranial Electrotherapy Stimulation (CES) Device in Conjunction With Life Coaching to Alleviate Burnout Symptoms in HealthCare Workers (HCWs)
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- 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.
- Conditions
- Psychiatric Disorder
- Being tested
- Cranial Electrical Stimulation (CES), Discussion, Health and Wellness Coach, Informational Intervention, Sham Intervention
- Medical subject headings
- Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranial Electrical Stimulation (CES)Procedure or surgery
Use CES device
DiscussionOther
Also called Discuss
Participate in discussions
Health and Wellness CoachBehavioural
Undergo coaching sessions
Informational InterventionOther
View video assignments
Sham InterventionProcedure or surgery
Also called Sham Comparator
Undergo sham intervention
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1- Arm 1 (Cranial Electrotherapy Stimulation (CES) + life coaching) | Experimental | 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. Receives: Procedure: Cranial Electrical Stimulation (CES); Other: Discussion; Behavioral: Health and Wellness Coach |
| Cohort 1 -Arm II (Sham device + life coaching sessions) | Sham comparator | 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. Receives: Other: Discussion; Behavioral: Health and Wellness Coach; Other: Informational Intervention; Procedure: Sham Intervention |
| Cohort 2 - Arm III - CES device + life coaching sessions | Experimental | 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. Receives: Procedure: Cranial Electrical Stimulation (CES); Other: Discussion; Behavioral: Health and Wellness Coach; Other: Informational Intervention |
| Cohort 2 - Arm IV (Sham device + life coaching sessions | Sham comparator | 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 Receives: Other: Discussion; Behavioral: Health and Wellness Coach; Other: Informational Intervention; Procedure: Sham Intervention |
| Cohort 3, Arm V (CES device + life coaching sessions) | Experimental | 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 Receives: Procedure: Cranial Electrical Stimulation (CES); Other: Discussion; Behavioral: Health and Wellness Coach |
| Cohort 3, Arm VI (Sham-device + life coaching sessions) | Sham comparator | 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. Receives: Other: Discussion; Behavioral: Health and Wellness Coach; Procedure: Sham Intervention |
| Cohort 4, Arm VII (CES device + life coaching sessions) | Experimental | 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. Receives: Procedure: Cranial Electrical Stimulation (CES); Other: Discussion; Behavioral: Health and Wellness Coach |
| Cohort 4, Arm VIII (Sham device + life coaching sessions) | Sham comparator | 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. Receives: Other: Discussion; Behavioral: Health and Wellness Coach; Procedure: Sham Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At baseline, 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.
Measured: At baseline, 8 weeks, and 15 weeks
Secondary outcomes (2)
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.
Measured: At baseline, 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.
Measured: At baseline, 8 weeks, and 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study start4 Feb 2026
- Primary completion4 Oct 2027 (estimated)
- Study completion4 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roswell Park Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy Gallagher, PsyD, Principal investigator, Roswell Park Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06977503
- Sponsor's protocol ID
- I-3956824
- Other IDs
- NCI-2025-03017, I-3956824
- Status last verified
- Oct 2026
- First submitted
- 9 May 2025
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Using a Cranial Electrotherapy Stimulation (CES) Device in Conjunction With Life Coaching to Alleviate Burnout Symptoms in HealthCare Workers (HCWs)
- ClinicalTrials.gov ID
- NCT06977503
- Acronym / sponsor ID
- I-3956824
- Conditions
- Psychiatric Disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Roswell Park Cancer InstituteUniversity, hospital or other
- Study start
- 4 Feb 2026 (actual)
- Primary completion
- 4 Oct 2027 (estimated)
- Study completion
- 4 Oct 2027 (estimated)
- First posted
- 18 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Cohort 1- Arm 1 (Cranial Electrotherapy Stimulation (CES) + life coaching) | Experimental | Procedure: Cranial Electrical Stimulation (CES), Other: Discussion, Behavioral: Health and Wellness CoachDevices 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. |
| Cohort 1 -Arm II (Sham device + life coaching sessions) | Sham comparator | Other: Discussion, Behavioral: Health and Wellness Coach, Other: Informational Intervention, Procedure: Sham InterventionDevices 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. |
| Cohort 2 - Arm III - CES device + life coaching sessions | Experimental | Procedure: Cranial Electrical Stimulation (CES), Other: Discussion, Behavioral: Health and Wellness Coach, Other: Informational InterventionParticipants 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. |
| Cohort 2 - Arm IV (Sham device + life coaching sessions | Sham comparator | Other: Discussion, Behavioral: Health and Wellness Coach, Other: Informational Intervention, Procedure: Sham InterventionParticipants 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 (CES device + life coaching sessions) | Experimental | Procedure: Cranial Electrical Stimulation (CES), Other: Discussion, Behavioral: Health and Wellness CoachParticipants 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 |
| Cohort 3, Arm VI (Sham-device + life coaching sessions) | Sham comparator | Other: Discussion, Behavioral: Health and Wellness Coach, Procedure: Sham InterventionParticipants 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 (CES device + life coaching sessions) | Experimental | Procedure: Cranial Electrical Stimulation (CES), Other: Discussion, Behavioral: Health and Wellness CoachParticipants 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. |
| Cohort 4, Arm VIII (Sham device + life coaching sessions) | Sham comparator | Other: Discussion, Behavioral: Health and Wellness Coach, Procedure: Sham InterventionParticipants 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. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cranial Electrical Stimulation (CES)Use CES device | Procedure or surgery | 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) |
| DiscussionAlso: DiscussParticipate in discussions | Other | Cohort 1 -Arm II (Sham device + life coaching sessions), Cohort 1- Arm 1 (Cranial Electrotherapy Stimulation (CES) + life coaching), Cohort 2 - Arm III - CES device + life coaching sessions, Cohort 2 - Arm IV (Sham device + life coaching sessions, Cohort 3, Arm V (CES device + life coaching sessions), Cohort 3, Arm VI (Sham-device + life coaching sessions), Cohort 4, Arm VII (CES device + life coaching sessions), Cohort 4, Arm VIII (Sham device + life coaching sessions) |
| Health and Wellness CoachUndergo coaching sessions | Behavioural | Cohort 1 -Arm II (Sham device + life coaching sessions), Cohort 1- Arm 1 (Cranial Electrotherapy Stimulation (CES) + life coaching), Cohort 2 - Arm III - CES device + life coaching sessions, Cohort 2 - Arm IV (Sham device + life coaching sessions, Cohort 3, Arm V (CES device + life coaching sessions), Cohort 3, Arm VI (Sham-device + life coaching sessions), Cohort 4, Arm VII (CES device + life coaching sessions), Cohort 4, Arm VIII (Sham device + life coaching sessions) |
| Informational InterventionView video assignments | Other | Cohort 1 -Arm II (Sham device + life coaching sessions), Cohort 2 - Arm III - CES device + life coaching sessions, Cohort 2 - Arm IV (Sham device + life coaching sessions |
| Sham InterventionAlso: Sham ComparatorUndergo sham intervention | Procedure or surgery | 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) |
Primary outcome
Symptoms of burnout in healthcare workers (HCWs)
Time frame: 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
Time frame: 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.
2 secondary outcomes
Self-reported resilience in HCWs
Time frame: At baseline, 8 weeks, and 15 weeks
HCW self-reported probability of employment retention
Time frame: At baseline, 8 weeks, and 15 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amy Gallagher, PsyD principal investigator
Roswell Park Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cranial Electrical Stimulation (CES), Discussion and Health and Wellness Coach in people with Psychiatric Disorder, run by Roswell Park Cancer Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptoms of burnout in healthcare workers (HCWs) (time frame: At baseline, 8 weeks, and 15 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.