Alpha-Stim AID + Life Coaching for Mental Health Disorders

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Roswell Park Cancer Institute

Disqualifiers: Pregnancy, Meniere's, Seizure, Pacemaker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: 12 weeks

40 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Amy A Case

Principal Investigator

Roswell Park Cancer Institute

Are You a Good Fit for This Trial?

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)

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Arm I (Alpha-Stim® + life coaching) Experimental Treatment 4 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 Group 6 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.

Who Is Running the Clinical Trial?

Roswell Park Cancer Institute

Lead Sponsor

Trials

427

Recruited

40,500+