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

Part of paid clinical trials in Buffalo, New York.

Sponsor
Roswell Park Cancer Institute
Study ID
NCT06977503
Status
Recruiting
Apply to this trial

Conditions

  • Psychiatric Disorder

Eligibility Criteria

Sex
ALL
Age
21 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Cranial Electrical Stimulation (CES) — PROCEDURE
    Use CES device
  • Discussion — OTHER
    Participate in discussions
  • Health and Wellness Coach — BEHAVIORAL
    Undergo coaching sessions
  • Informational Intervention — OTHER
    View video assignments
  • Sham Intervention — PROCEDURE
    Undergo sham intervention

Study Details

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.

Key Dates

First listed
May 18, 2025
Start date
Feb 4, 2026
Status verified
Sep 2026
Primary completion
Oct 4, 2026
Completion
Oct 4, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Cohort 1- Arm 1 (Cranial Electrotherapy Stimulation (CES) + life coaching)
    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.
  • Sham Comparator: Cohort 1 -Arm II (Sham device + life coaching sessions)
    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.
  • Experimental: Cohort 2 - Arm III - CES device + life coaching sessions
    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.
  • Sham Comparator: Cohort 2 - Arm IV (Sham device + life coaching sessions
    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
  • Experimental: Cohort 3, Arm V (CES device + life coaching sessions)
    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
  • Sham Comparator: Cohort 3, Arm VI (Sham-device + life coaching sessions)
    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.
  • Experimental: Cohort 4, Arm VII (CES device + life coaching sessions)
    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.
  • Sham Comparator: Cohort 4, Arm VIII (Sham device + life coaching sessions)
    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.

Primary Outcome Measure

Symptoms of burnout in healthcare workers (HCWs) [ Time Frame: At baseline, 8 weeks, and 15 weeks ]

Locations (1)

FacilityCityStateZIPSite coordinators
Roswell Park Cancer InstituteBuffaloNew York14263
Amy Gallagher, PsyD
[email protected]
716-845-7399
Amy Gallagher (PRINCIPAL_INVESTIGATOR)

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