New therapies to help military personnel with anxiety

Novel Mental Health Therapies to Improve Military Readiness

This study is testing if a new device called Alpha-Stim can help military personnel with anxiety feel better compared to a fake treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 160 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Mike O'Callaghan Military Hospital (fed)
• Locations: 1 site (Nellis Air Force Base, Nevada)
• Trial ID: NCT05887713 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of Cranial Electrotherapy Stimulation (CES), also known as Alpha-Stim, in treating generalized anxiety among Department of Defense (DoD) beneficiaries. Participants will receive either the active CES treatment or a sham (placebo) treatment to compare outcomes. The study aims to address the increasing prevalence of anxiety disorders in the military, where traditional therapies may not be suitable due to their side effects. By focusing on a nonpharmacological approach, the trial seeks to improve mental health and readiness for active-duty personnel.

Who should consider this trial

Good fit: Ideal candidates for this study are active-duty military personnel and DoD beneficiaries aged 18 or older who exhibit symptoms of generalized anxiety.

Not a fit: Patients with severe mental health disorders such as bipolar disorder, schizophrenia, or those on specific anti-psychotic medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a non-invasive and effective option for managing anxiety in military personnel, enhancing their overall readiness and quality of life.

How similar studies have performed: While CES has been used in various contexts, this specific application within the military setting is relatively novel and has not been extensively tested.

Eligibility criteria

\*\*Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study\*\*

Inclusion Criteria:

* Active Duty and DoD Beneficiaries aged 18 or older
* Threshold Generalized Anxiety symptoms based on MINI scoring and GAD-7 score of 10 or higher

Exclusion Criteria:

* Bi-polar disorder, schizophrenia or schizoaffective disorders, manic depressive disorder, autism spectrum disorders, binge eating disorder, anorexia nervosa, bulimia, obsessive compulsive disorder, gender dysphoria (transgender is not an exclusion unless subject meets DSM-5 criteria for gender dysphoria), dementia, mental or other health disorders that prevent subjects from adhering to treatment.This will be verified by patient report or by chart review.
* Subjects taking anti-psychotic medications including but not limited to; risperidone, quetiapine, olanzapine, ziprasidone, paliperidone, aripiprazole and clozapine.
* Subjects taking any seizure medications (ex: Dilantin)
* Subjects who use nicotine in any form: Cigarettes, Vape pens, chewing tobacco, tobacco pouches, patches, gum.
* Subjects with medical implant devices such as pacemakers or any device contraindicated for CES treatment.
* Subjects who have started, altered, or discontinued use of any anti-depressant or anxiolytic in the past four weeks (including any medication in the following classes; selective serotonin reuptake inhibitors \[SSRI\], serotonin and norepinephrine reuptake inhibitors \[SnRI\], Wellbutrin, beta blockers specifically taken for anxiety, monoamine oxidase inhibitors \[MAOI\], tricyclic antidepressants \[TCA\], benzodiazepenes).
* Pregnancy
* Current or previous use of a CES device.
* Experimental or clinical brain stimulation such as deep brain stimulation or transcranial magnetic stimulation for any indication (current or past 3 months).
* Psychotherapy for anxiety based on exposure therapy (current or past 6 weeks)
* Seizure disorder (current or history). History of febrile childhood seizures is allowed.
* Higher than low suicide risk on the Columbia Suicide Severity Rating Scale (CSSRS).
* Known cardiac arrythmias
* Anything that would make participation in the study unsafe or medically unadvisable in the assessment of a study clinician.

Where this trial is running

Nellis Air Force Base, Nevada

• Mike O'Callaghan Military Medical Center — Nellis Air Force Base, Nevada, United States (RECRUITING)

Study contacts

• Study coordinator: Amanda Crawford, MSHS

Conditions: Anxiety, Alpha Stim, Cranial Electrotherapy Stimulation, Cognitive Behavioral Therapy, Heart Rate Variability