Novel Mental Health Therapies to Improve Military Readiness

Running, not enrolling · Not applicable · Has a placebo group

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

In brief

To evaluate the efficacy of CES as a therapy to treat and mitigate symptoms of generalized anxiety in DoD beneficiaries in a prospective clinical trial and compare this to sham (placebo) CES.

Key facts

Study ID

NCT05887713

Run by

David Moss

People needed

200

Starts

2024-01-01

Expected to finish

2026-12-01

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

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

Full record on ClinicalTrials.gov

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