Novel Mental Health Therapies to Improve Military Readiness

Launched by DAVID MOSS · May 24, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at a new treatment called Cranial Electrotherapy Stimulation (CES) to help reduce symptoms of generalized anxiety in military personnel and their families. The goal is to see how effective CES is compared to a placebo, which is a fake treatment that does not have any therapeutic effects. This study is open to active-duty service members and Department of Defense (DoD) beneficiaries aged 18 and older who experience significant anxiety, as indicated by specific scoring measures.

To participate, individuals must be able to receive care at Nellis Air Force Base and should not have certain mental health conditions like bipolar disorder or schizophrenia, nor can they be taking specific medications that could interfere with the study. Participants can expect to be part of a respectful research environment where their well-being is a priority, and they will receive guidance throughout the process. It's important to note that this study aims to improve mental health support within the military community, potentially leading to better readiness and overall well-being.

Gender

ALL

Eligibility criteria

• • \*\*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.