Novel Mental Health Therapies to Improve Military Readiness

Anxiety Clinical Trial

Official title: Novel Mental Health Therapies to Improve Military Readiness

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

Anxiety disorders are diverse. The Veterans Administration diagnostic code options for anxiety are Post-Traumatic Stress Disorder (PTSD), Generalized Anxiety Disorder (GAD), obsessive- compulsive disorder (OCD), Other Specified Anxiety Disorder, phobias and Social Anxiety Disorder, and panic disorder and/or agoraphobia. In the US Military, anxiety disorders are increasing in prevalence.

According to one DoD report, by 2012 anxiety disorders made up more medical encounters than any other mental disorder and was fourth in overall encounter categories including non-mental health related injuries and illnesses (Anxiety Disorders Active Component).

Traditional mental health therapies and active-duty military readiness are often mutually exclusive due to habit-forming and significant physical and mental adverse side effects resulting from standard mental health therapies. In veterans, while work readiness is less of an issue, traditional mental health therapies affect activities of daily living and overall quality of life.

Nonpharmacological approaches to mental health therapy in the military health system are therefore relevant and timely (Bravo).

Cranial Electrotherapy Stimulation (CES): Also known by the proprietary name Alpha-Stim, cranial electrotherapy stimulation is a noninvasive neuromodulation treatment commonly used to mitigate anxiety, posttraumatic stress, insomnia, and depression. The device is FDA cleared for the treatment of anxiety, insomnia, depression, and acute post-traumatic and chronic pain.

Active duty servicemembers and veterans using the device reported at least 50% improvement in each area (Kirsch). Newer cranial electrotherapy stimulation devices that attach to the patients' ears significantly improved general and state-anxiety (Kim, Morriss). Set up of alpha stim is demonstrated at the following website; https://youtu.be/ImDQ2HWAS6U

Cognitive behavioral therapy is a form of talk therapy shown to be effective for GAD. While its effectiveness is proven, it requires referral to a trained counselor or therapist, requires multiple visits and can cause patients to miss work or other events (Borza). Brief CBT is a specific method of CBT that consists of 1. psychoeducation on the Cognitive Behavioral Model 2.

assessment of frequency and severity of symptoms, as well as desired cognitive and behavioral change (ie goal setting) 3. Practice developing insight and cognitive disputation using the Antecedents, Behavior, Consequences (ABC) Model 4) Review subjects' homework (Thought Record) and reinforce cognitive disputation of unhelpful thinking patterns during appointments (Cully).

There are multiple screening/diagnostic scales to determine the presence and severity of GAD. The Mini International Neuropsychiatric Interview is a validated clinician administered brief structured interview for multiple major psychiatric disorders including anxiety (Sheehan). The Beck Anxiety Inventory (BAI) is a 21 item self-report and addresses comprehensive symptoms of anxiety.

This tool specifically can be used to monitor symptoms over time (Beck). The Hamilton Anxiety Rating Scale (HAM-A) is a 14-item validated clinician administered questionnaire that measures the severity of both psychic and somatic anxiety symptoms (Hamilton).

Heart Rate Variability (HRV) has been used as a surrogate marker for autonomic function

/balance. Low HRV correlates with increased sympathetic tone and studies indicate that patients with depression and anxiety disorders may have abnormally low HRV compared to controls (Servant).

This study will utilize the Firstbeat Bodyguard 2, a device designed to act as a professional grade sensor of short and long term HRV measurements. As a non medical device, it does not require FDA clearance.

Vagal efficiency is measured by the slope of the linear regression between heart rate and HRV. It represents the change in heart rate per unit increase/decrease in HRV. Clinically it is theorized that it measures the ability of the parasympathetic nervous system to adapt to dynamic changes in sympathetic tone (Kovacic).

This study will 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. ;

Related Conditions & MeSH terms

• Anxiety
• Cognitive Behavioral Therapy
• Heart Rate Variability

• NCT number: NCT05887713
• Study type: Interventional
• Source: Mike O'Callaghan Military Hospital
• Contact: Amanda Crawford, MSHS
• Phone: 7026533583
• Email: amanda.j.crawford.ctr@health.mil
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2024
• Completion date: June 2025