Novel Mental Health Therapies to Improve Military Readiness (NCT05887713) | Clinical Trial Compass
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 range18 Years
SexALL
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\*\*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…