Active — Not RecruitingNot Applicable

Novel Mental Health Therapies to Improve Military Readiness

United States200 participantsStarted 2024-01-01

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

\*\*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 \[S…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is comparing Alpha-Stim cranial electrotherapy stimulation with cognitive behavioral therapy for anxiety — given my specific situation, is one of these approaches already considered a standard of care option I should try first before considering a study like this?
2Since the trial is no longer actively recruiting, is there any way for me to still be considered for participation, or are there similar studies comparing these same treatments that are still open and enrolling?
3This study is measuring heart rate variability and vagal efficiency alongside standard anxiety scales — what do those physiological measures actually tell us about how well a treatment is working, and why does that matter for my care?
4The trial is rated Phase NA, which often means it's studying a device or behavioral intervention rather than a drug — does that change the kind of safety concerns I should be thinking about compared to a medication trial?
5If I can't join this trial, would my doctor consider trying Alpha-Stim or CBT as part of my regular treatment for anxiety, and what does the existing evidence say about how well either of them works?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Beck Anxiety Inventory (BAI)

Timeframe: Visit 1 (Week 0)

Beck Anxiety Inventory (BAI)

Timeframe: Visit 8 (Week 10)

Hamilton Anxiety Rating Scale (HAM-A)

Timeframe: Visit 1 (Week 0)

Hamilton Anxiety Rating Scale (HAM-A)

Timeframe: Visit 8 (Week 10)

Heart Rate Variability (HRV)

Timeframe: Visit 1 (Week 0)

Heart Rate Variability (HRV)

Timeframe: Visit 8 (Week 10)

Vagal Efficiency (VE)

Timeframe: Visit 1 (Week 0)

Vagal Efficiency (VE)

Timeframe: Visit 8 (Week 10)

Trial details

NCT IDNCT05887713

SponsorDavid Moss

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2026-12

View on ClinicalTrials.gov More Anxiety trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Beck Anxiety Inventory (BAI)

Timeframe: Visit 1 (Week 0)

Beck Anxiety Inventory (BAI)

Timeframe: Visit 8 (Week 10)

Hamilton Anxiety Rating Scale (HAM-A)

Timeframe: Visit 1 (Week 0)

Hamilton Anxiety Rating Scale (HAM-A)

Timeframe: Visit 8 (Week 10)

Heart Rate Variability (HRV)

Timeframe: Visit 1 (Week 0)

Heart Rate Variability (HRV)

Timeframe: Visit 8 (Week 10)

Vagal Efficiency (VE)

Timeframe: Visit 1 (Week 0)

Vagal Efficiency (VE)

Timeframe: Visit 8 (Week 10)