Novel Mental Health Therapies to Improve Military Readiness
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.
Conditions:
🦠 Anxiety 🦠 Alpha Stim 🦠 Cranial Electrotherapy Stimulation 🦠 Cognitive Behavioral Therapy 🦠 Heart Rate Variability
🗓️ Study Start (Actual) 1 January 2024
🗓️ Primary Completion (Estimated) June 2025
✅ Study Completion (Estimated) June 2025
👥 Enrollment (Estimated) 160
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Nellis Air Force Base, Nevada, United States

📋 Eligibility Criteria

Description

  • \*\*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.
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 24 May 2023
  • First Submitted that Met QC Criteria 24 May 2023
  • First Posted 5 June 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 12 January 2024
  • Last Update Posted 16 January 2024
  • Last Verified January 2024