40 Participants Needed

Alpha-Stim AID + Life Coaching for Mental Health Disorders

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Roswell Park Cancer Institute
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Research Team

AA

Amy A Case

Principal Investigator

Roswell Park Cancer Institute

Eligibility Criteria

This trial is for oncology healthcare workers experiencing burnout and moral distress. Participants should be seeking ways to improve their mental health, resilience, and job satisfaction.

Inclusion Criteria

Participant has access to a computer with internet access and an email address
Ability to read and write in English
Patient-facing healthcare workers (e.g., medical doctor, advanced practice provider, nurse)
See 8 more

Exclusion Criteria

Subjects who self-report as pregnant or nursing. Pregnancy must be verified with a urine test for all persons of childbearing potential with a uterus
Subjects with a self-reported history of 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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Alpha-Stim® or sham device daily and participate in virtual group life coaching sessions

12 weeks
3 virtual group sessions

Follow-up

Participants are monitored for changes in burnout symptoms, moral distress, resilience, and employment retention

4 weeks

Treatment Details

Interventions

  • Alpha-Stim AID®
Trial Overview The study tests if Alpha-Stim AID®, a device offering cranial electrical stimulation, combined with life coaching can reduce symptoms of burnout and moral distress in healthcare professionals.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (Alpha-Stim® + life coaching)Experimental Treatment4 Interventions
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 II: Arm II (Sham device + life coaching sessions)Placebo Group6 Interventions
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials
427
Recruited
40,500+
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