Novel Mental Health Therapies to Improve Military Readiness

NCT05887713 | Active Not Recruiting FDA Device

• 1 other identifier: alpha stim
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (8)

• Beck Anxiety Inventory (BAI)

  BAI total scores range from 0 to 63; higher total scores indicate more severe anxiety symptoms. Scores are clinically categorized as 0-7 (minimal anxiety) 8-15 (mild anxiety), 16-25 (moderate anxiety), and 26-63 (severe anxiety). The BAI and HAM-A are mildly correlated. BAI will be treated as normally distributed allowing parametric statistical methods to be used. Baseline BAI will be obtained.

  Visit 1 (Week 0)

• Beck Anxiety Inventory (BAI)

  BAI total scores range from 0 to 63; higher total scores indicate more severe anxiety symptoms. Scores are clinically categorized as 0-7 (minimal anxiety) 8-15 (mild anxiety), 16-25 (moderate anxiety), and 26-63 (severe anxiety). The BAI and HAM-A are mildly correlated. BAI will be treated as normally distributed allowing parametric statistical methods to be used. BAI will be obtained.

  Visit 8 (Week 10)

• Hamilton Anxiety Rating Scale (HAM-A)

  HAM-A total scores range from 0 to 56. Scores are clinically categorized as 17 or less (mild anxiety), 18-24 (moderate anxiety), and 25-30 (severe anxiety). HAM-A will be treated as normally distributed allowing parametric statistical methods to be used. Baseline HAM-A will be obtained.

  Visit 1 (Week 0)

• Hamilton Anxiety Rating Scale (HAM-A)

  HAM-A total scores range from 0 to 56. Scores are clinically categorized as 17 or less (mild anxiety), 18-24 (moderate anxiety), and 25-30 (severe anxiety). HAM-A will be treated as normally distributed allowing parametric statistical methods to be used. HAM-A will be obtained.

  Visit 8 (Week 10)

• Heart Rate Variability (HRV)

  Heart Rate Variability (HRV) time domain measures estimate the statistical variability of interbeat intervals. HRV will be obtained using the First Beat Bodyguard 2. Subjects will have the device placed according to the manufacturer's instructions on the torso. HRV will be captured for 2 minutes in a seated position, then 2 minutes in a standing position, then 2 minutes in a seated position. HRV, and vagal efficiency will be calculated using this data. Subjects will be instructed not to consume caffeine, alcohol or nicotine containing products within 12 hours of HRV data collection. Subjects will be told not to take anti-cholinergic medications (ex: antihistamines), central nervous system depressants or central nervous system stimulant medications within 24 hours of HRV measurement. (Based on literature review, alcohol, caffeine and nicotine are excreted completely within 12 hours and the majority of medications listed are excreted within 24-48 hours.)

  Visit 1 (Week 0)

• Heart Rate Variability (HRV)

  Heart Rate Variability (HRV) time domain measures estimate the statistical variability of interbeat intervals. HRV will be obtained using the First Beat Bodyguard 2. Subjects will have the device placed according to the manufacturer's instructions on the torso. HRV will be captured for 2 minutes in a seated position, then 2 minutes in a standing position, then 2 minutes in a seated position. HRV, and vagal efficiency will be calculated using this data. Subjects will be instructed not to consume caffeine, alcohol or nicotine containing products within 12 hours of HRV data collection. Subjects will be told not to take anti-cholinergic medications (ex: antihistamines), central nervous system depressants or central nervous system stimulant medications within 24 hours of HRV measurement. (Based on literature review, alcohol, caffeine and nicotine are excreted completely within 12 hours and the majority of medications listed are excreted within 24-48 hours.)

  Visit 8 (Week 10)

• Vagal Efficiency (VE)

  Vagal efficiency (VE) mean (SD) in a sample having a history of maltreatment were 61.7(19.5) and in a sample without a history of maltreatment were 69.6 (25.5). VE will be treated as normally distributed allowing parametric statistical methods to be used. 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.

  Visit 1 (Week 0)

• Vagal Efficiency (VE)

  Vagal efficiency (VE) mean (SD) in a sample having a history of maltreatment were 61.7(19.5) and in a sample without a history of maltreatment were 69.6 (25.5). VE will be treated as normally distributed allowing parametric statistical methods to be used. 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

  Visit 8 (Week 10)

Study Arms (2)

Group 1: Active CES

EXPERIMENTAL

Active CES treatment at home 40 minutes daily for 6 weeks

Device: Experimental: Alpha-Stim 100

Group 2: Sham CES

SHAM COMPARATOR

Sham CES treatment at home 40 minutes daily for 6 weeks

Device: Sham Comparator

Interventions

Experimental: Alpha-Stim 100 DEVICE

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 1: Active CES

Sham Comparator DEVICE

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.

Group 2: Sham CES

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• David Moss: lead

Study Sites (1)

Mike O'Callaghan Military Medical Center

Nellis Air Force Base, Nevada, 89191, United States

Location

Related Publications (12)

• 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

  BACKGROUND

• 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.

  PMID: 31131067 BACKGROUND

• 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.

  PMID: 25830798 BACKGROUND

• 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.

  PMID: 34706456 BACKGROUND

• 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.

  PMID: 28867944 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 16717171 BACKGROUND

• 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.

  PMID: 9881538 BACKGROUND

• 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.

  PMID: 3204199 BACKGROUND

• 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.

  PMID: 13638508 BACKGROUND

• 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.

  PMID: 19853714 BACKGROUND

• 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.

  PMID: 32732620 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor/Principal Investigator

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 5, 2023
• Study Start: January 1, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)