Alpha-Stim AID® Together With Life Coaching for the Support of Burnout Symptoms in Healthcare Workers

Not Applicable

Not yet recruiting

• Conditions: Psychiatric Disorder

• Registration Number: NCT06977503
• Lead Sponsor: Roswell Park Cancer Institute

Brief Summary

This clinical trial evaluates the effect of life coaching together with Alpha-Stim AID® (Anxiety, Insomnia, Depression), also known as Alpha-Stim®, 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. Alpha-Stim® is a device 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 Alpha-Stim®, 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 Alpha-Stim® 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 Alpha-Stim® 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 Alpha-Stim® 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. During weeks 7-12, 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. During weeks 7-12, participants cross-over and use the Alpha-Stim® device QD over 1 hour 5 days per week for 6 weeks on study.

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-09
• Study First Submitted QC: 2025-05-09
• Study First Posted: 2025-05-18
• Last Update Submitted: 2025-05-27
• Last Update Posted: 2025-05-28
• Study Start: 2025-06-15
• Primary Completion: 2026-05-15
• Study Completion: 2027-05-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 40

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 Alpha-Stim® 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
• Unwilling or unable to follow protocol requirements

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Symptoms of burnout in healthcare workers (HCWs)	At baseline, 6 weeks, and 12 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, 6 weeks, and 12 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 Outcome Measures

Name	Time	Method
Self-reported resilience in HCWs	At baseline, 6 weeks, and 12 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, 6 weeks, and 12 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.

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States