Novel Mental Health Therapies to Improve Military Readiness
David Moss
160 participants
Jan 1, 2024
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria3
- \*\*Patients must be able to get care at Nellis Air Force Base (a military installation) in order to participate in this study\*\*
- 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 Criteria14
- 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.
Interventions
Subjects in CES intervention group will run CES at home daily for 6 weeks. Study staff will call weekly to ensure adherence to CES treatment, gather CES usage data for the week and to answer any questions.
Subjects in CES sham group will run sham CES at home daily for 6 weeks. Study staff will call weekly to ensure adherence to sham CES treatment, gather sham CES usage data for the week and to answer any questions.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05887713