Novel Mental Health Therapies to Improve Military Readiness
NCT ID: NCT05887713
Last Updated: 2025-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
160 participants
INTERVENTIONAL
2024-01-01
2025-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group 1: Active CES
Active CES treatment at home 40 minutes daily for 6 weeks
Experimental: 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.
Group 2: Sham CES
Sham CES treatment at home 40 minutes daily for 6 weeks
Sham 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.
Interventions
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Experimental: 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.
Sham 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.
Eligibility Criteria
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Inclusion Criteria
* Threshold Generalized Anxiety symptoms based on MINI scoring and GAD-7 score of 10 or higher
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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David Moss
FED
Responsible Party
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David Moss
Doctor/Principal Investigator
Locations
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Mike O'Callaghan Military Medical Center
Nellis Air Force Base, Nevada, United States
Countries
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Central Contacts
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Facility Contacts
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References
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Anxiety Disorders, Active Component, U.S. Armed Forces, 2000-2012. October 2013 Vol. 20 No. 10M S M R. https://deploymentpsych.org/system/files/member_resource /2013_MSMR_Anxiety_Disorders_Active_Component_US_Armed_Forces_2000-2012.pdf
Bravo AJ, Witkiewitz K, Kelley ML, Redman JC. Prevalence of Mental Health Problems and Willingness to Participate in a Mindfulness Treatment: An Examination among Veterans Injured in Combat. Mindfulness (N Y). 2019 May;10(5):953-963. doi: 10.1007/s12671-018-1047-4. Epub 2018 Nov 10.
Kirsch DL, Price LR, Nichols F, Marksberry JA, Platoni KT. Military service member and veteran self reports of efficacy of cranial electrotherapy stimulation for anxiety, posttraumatic stress disorder, insomnia, and depression. US Army Med Dep J. 2014 Oct-Dec:46-54.
Kim J, Kim H, Kim DH, Lee SK, Roh JY, Kim CH, Chang JG, Roh D. Effects of cranial electrotherapy stimulation with novel in-ear electrodes on anxiety and resting-state brain activity: A randomized double-blind placebo-controlled trial. J Affect Disord. 2021 Dec 1;295:856-864. doi: 10.1016/j.jad.2021.08.141. Epub 2021 Sep 3.
Borza L. Cognitive-behavioral therapy for generalized anxiety. Dialogues Clin Neurosci. 2017 Jun;19(2):203-208. doi: 10.31887/DCNS.2017.19.2/lborza.
Cully, J.A., Dawson, D.B., Hamer, J., & Tharp, A.L. 2020. A Provider's Guide to Brief Cognitive Behavioral Therapy. Department of Veterans Affairs South Central MIRECC, Houston, TX
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, Hergueta T, Baker R, Dunbar GC. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59 Suppl 20:22-33;quiz 34-57.
Beck AT, Epstein N, Brown G, Steer RA. An inventory for measuring clinical anxiety: psychometric properties. J Consult Clin Psychol. 1988 Dec;56(6):893-7. doi: 10.1037//0022-006x.56.6.893. No abstract available.
HAMILTON M. The assessment of anxiety states by rating. Br J Med Psychol. 1959;32(1):50-5. doi: 10.1111/j.2044-8341.1959.tb00467.x. No abstract available.
Servant D, Logier R, Mouster Y, Goudemand M. [Heart rate variability. Applications in psychiatry]. Encephale. 2009 Oct;35(5):423-8. doi: 10.1016/j.encep.2008.06.016. Epub 2008 Dec 18. French.
Kovacic K, Kolacz J, Lewis GF, Porges SW. Impaired Vagal Efficiency Predicts Auricular Neurostimulation Response in Adolescent Functional Abdominal Pain Disorders. Am J Gastroenterol. 2020 Sep;115(9):1534-1538. doi: 10.14309/ajg.0000000000000753.
Other Identifiers
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alpha stim
Identifier Type: -
Identifier Source: org_study_id
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