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

NCT ID: NCT06977503

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2027-12-15

Brief Summary

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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

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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.

Conditions

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Psychiatric Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators
Researchers will be blinded with respect to subjects' study number, pre/post assessment data, and Alpha-Stim® 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.

Study Groups

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Arm I (Alpha-Stim® + life coaching)

During weeks 1-6, participants use the Alpha-Stim® 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 sham device QD over 1 hour 5 days per week for 6 weeks on study.

Group Type EXPERIMENTAL

Discussion

Intervention Type OTHER

Participate in discussions

Health and Wellness Coach

Intervention Type BEHAVIORAL

Undergo coaching sessions

Informational Intervention

Intervention Type OTHER

View video assignments

Survey Administration

Intervention Type OTHER

Ancillary studies

Arm II (Sham device + life coaching sessions)

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.

Group Type SHAM_COMPARATOR

Cranial Electrical Stimulation

Intervention Type PROCEDURE

Use Alpha-Stim® device

Discussion

Intervention Type OTHER

Participate in discussions

Health and Wellness Coach

Intervention Type BEHAVIORAL

Undergo coaching sessions

Informational Intervention

Intervention Type OTHER

View video assignments

Sham Intervention

Intervention Type PROCEDURE

Undergo sham intervention

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Cranial Electrical Stimulation

Use Alpha-Stim® device

Intervention Type PROCEDURE

Discussion

Participate in discussions

Intervention Type OTHER

Health and Wellness Coach

Undergo coaching sessions

Intervention Type BEHAVIORAL

Informational Intervention

View video assignments

Intervention Type OTHER

Sham Intervention

Undergo sham intervention

Intervention Type PROCEDURE

Survey Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Discuss Sham Comparator

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Roswell Park Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amy A Case

Role: PRINCIPAL_INVESTIGATOR

Roswell Park Cancer Institute

Locations

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Roswell Park Cancer Institute

Buffalo, New York, United States

Site Status

Countries

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United States

Facility Contacts

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Amy A. Case

Role: primary

Other Identifiers

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NCI-2025-03017

Identifier Type: REGISTRY

Identifier Source: secondary_id

I-3956824

Identifier Type: OTHER

Identifier Source: secondary_id

I-3956824

Identifier Type: -

Identifier Source: org_study_id