RecruitingNot ApplicableNCT05887713

Novel Mental Health Therapies to Improve Military Readiness

Sponsor

David Moss

Enrollment

160 participants

Start Date

Jan 1, 2024

Study Type

INTERVENTIONAL

Conditions

Anxiety Heart Rate Variability Cognitive Behavioral Therapy Alpha Stim Cranial Electrotherapy Stimulation

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing new mental health treatment approaches for active-duty military personnel and Department of Defense beneficiaries who have significant anxiety. Participants must receive care at Nellis Air Force Base. **You may be eligible if...** - You are active-duty military or a DoD beneficiary aged 18 or older - You receive care at Nellis Air Force Base - You have significant generalized anxiety symptoms (GAD-7 score of 10 or higher) **You may NOT be eligible if...** - You have bipolar disorder, schizophrenia, manic depressive disorder, autism spectrum disorder, certain eating disorders, OCD, or dementia - You are currently taking medications that conflict with the study treatments - Your anxiety is better explained by another medical or psychiatric condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEExperimental: Alpha-Stim 100

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.

DEVICESham Comparator

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.